-
The Cochrane Database of Systematic... Mar 2012Riluzole is approved for the treatment of amyotrophic lateral sclerosis in most countries. Questions persist about its clinical utility because of high cost and modest... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Riluzole is approved for the treatment of amyotrophic lateral sclerosis in most countries. Questions persist about its clinical utility because of high cost and modest efficacy.
OBJECTIVES
To examine the efficacy of riluzole in prolonging survival and in delaying the use of surrogates (tracheostomy and mechanical ventilation) to sustain survival, and to assess the effect of riluzole upon functional health.
SEARCH METHODS
We searched the Cochrane Neuromuscular Disease Group Specialized Register (20 April 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (2011, Issue 2), MEDLINE (1966 to April 2011), EMBASE (1980 to May 2011) and made enquiries of authors of trials, Aventis (manufacturer of riluzole) and other experts in the field.
SELECTION CRITERIA
Types of studies: randomized controlled trials
TYPES OF PARTICIPANTS
adults with a diagnosis of amyotrophic lateral sclerosis Types of interventions: treatment with riluzole or placebo Types of outcome measures: Primary: pooled hazard ratio of tracheostomy-free survival over all time points with riluzole 100 mg. Secondary: per cent mortality with riluzole 50 mg, 100 mg and 200 mg; neurologic function, muscle strength and adverse events.
DATA COLLECTION AND ANALYSIS
One author performed data extraction and two other authors checked them. One author checked the data and entered them into the computer. The other authors verified the data entry. We obtained missing data from the trial authors whenever possible.
MAIN RESULTS
The four trials examining tracheostomy-free survival included a total of 974 riluzole-treated patients and 503 placebo-treated patients. No new randomized controlled trials were found when we updated the searches for this update in 2011. The methodological quality was acceptable and three trials were easily comparable, although one trial (169 participants) included older patients in more advanced stages of amyotrophic lateral sclerosis and one (195 participants) had multiple primary endpoints. Riluzole 100 mg per day provided a benefit for the homogeneous group of patients in the first two trials (hazard ratio (HR) 0.80, 95% confidence internal (CI) 0.64 to 0.99, P= 0.042) and there was no evidence of heterogeneity (P = 0.33). When the third trial (which included older and more seriously affected patients) was added, there was evidence of heterogeneity (P < 0.0001) and the overall treatment effect was reduced but still significant (HR 0.84, 95% CI 0.698 to 0.997, P= 0.046). This represented a 9% gain in the probability of surviving one year (49% in the placebo and 58% in the riluzole group), and increased median survival from 11.8 to 14.8 months. There was a small beneficial effect on both bulbar and limb function, but not on muscle strength. A three-fold increase in serum alanine transferase was more frequent in riluzole-treated patients than controls (mean difference 2.62, 95% CI 1.59 to 4.31).
AUTHORS' CONCLUSIONS
Riluzole 100 mg daily is reasonably safe and probably prolongs median survival by about two to three months in patients with amyotrophic lateral sclerosis.
Topics: Age Factors; Amyotrophic Lateral Sclerosis; Excitatory Amino Acid Antagonists; Humans; Life Expectancy; Neuroprotective Agents; Randomized Controlled Trials as Topic; Riluzole; Tracheostomy
PubMed: 22419278
DOI: 10.1002/14651858.CD001447.pub3 -
The Cochrane Database of Systematic... Jan 2015Long-term mechanical ventilation is the most common situation for which tracheostomy is indicated for patients in intensive care units (ICUs). 'Early' and 'late'... (Review)
Review
BACKGROUND
Long-term mechanical ventilation is the most common situation for which tracheostomy is indicated for patients in intensive care units (ICUs). 'Early' and 'late' tracheostomies are two categories of the timing of tracheostomy. Evidence on the advantages attributed to early versus late tracheostomy is somewhat conflicting but includes shorter hospital stays and lower mortality rates.
OBJECTIVES
To evaluate the effectiveness and safety of early (≤ 10 days after tracheal intubation) versus late tracheostomy (> 10 days after tracheal intubation) in critically ill adults predicted to be on prolonged mechanical ventilation with different clinical conditions.
SEARCH METHODS
This is an update of a review last published in 2012 (Issue 3, The Cochrane Library) with previous searches run in December 2010. In this version, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 8); MEDLINE (via PubMed) (1966 to August 2013); EMBASE (via Ovid) (1974 to August 2013); LILACS (1986 to August 2013); PEDro (Physiotherapy Evidence Database) at www.pedro.fhs.usyd.edu.au (1999 to August 2013) and CINAHL (1982 to August 2013). We reran the search in October 2014 and will deal with any studies of interest when we update the review.
SELECTION CRITERIA
We included all randomized and quasi-randomized controlled trials (RCTs or QRCTs) comparing early tracheostomy (two to 10 days after intubation) against late tracheostomy (> 10 days after intubation) for critically ill adult patients expected to be on prolonged mechanical ventilation.
DATA COLLECTION AND ANALYSIS
Two review authors extracted data and conducted a quality assessment. Meta-analyses with random-effects models were conducted for mortality, time spent on mechanical ventilation and time spent in the ICU.
MAIN RESULTS
We included eight RCTs (N = 1977 participants). At the longest follow-up time available in these studies, evidence of moderate quality from seven RCTs (n = 1903) showed lower mortality rates in the early as compared with the late tracheostomy group (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.70 to 0.98; P value 0.03; number needed to treat for an additional beneficial outcome (NNTB) ≅ 11). Divergent results were reported on the time spent on mechanical ventilation and no differences were noted for pneumonia, but the probability of discharge from the ICU was higher at day 28 in the early tracheostomy group (RR 1.29, 95% CI 1.08 to 1.55; P value 0.006; NNTB ≅ 8).
AUTHORS' CONCLUSIONS
The whole findings of this systematic review are no more than suggestive of the superiority of early over late tracheostomy because no information of high quality is available for specific subgroups with particular characteristics.
Topics: Critical Care; Critical Illness; Humans; Length of Stay; Pneumonia; Randomized Controlled Trials as Topic; Respiration, Artificial; Time Factors; Tracheostomy
PubMed: 25581416
DOI: 10.1002/14651858.CD007271.pub3 -
Journal of Physiotherapy Jul 2015Does inspiratory muscle training improve inspiratory muscle strength in adults receiving mechanical ventilation? Does it improve the duration or success of weaning? Does... (Review)
Review
QUESTION
Does inspiratory muscle training improve inspiratory muscle strength in adults receiving mechanical ventilation? Does it improve the duration or success of weaning? Does it affect length of stay, reintubation, tracheostomy, survival, or the need for post-extubation non-invasive ventilation? Is it tolerable and does it cause adverse events?
DESIGN
Systematic review of randomised trials.
PARTICIPANTS
Adults receiving mechanical ventilation.
INTERVENTION
Inspiratory muscle training versus sham or no inspiratory muscle training.
OUTCOME MEASURES
Data were extracted regarding: inspiratory muscle strength and endurance; the rapid shallow breathing index; weaning success and duration; duration of mechanical ventilation; reintubation; tracheostomy; length of stay; use of non-invasive ventilation after extubation; survival; readmission; tolerability and adverse events.
RESULTS
Ten studies involving 394 participants were included. Heterogeneity within some meta-analyses was high. Random-effects meta-analyses showed that the training significantly improved maximal inspiratory pressure (MD 7 cmH2O, 95% CI 5 to 9), the rapid shallow breathing index (MD 15 breaths/min/l, 95% CI 8 to 23) and weaning success (RR 1.34, 95% CI 1.02 to 1.76). Although only assessed in individual studies, significant benefits were also reported for the time spent on non-invasive ventilation after weaning (MD 16 hours, 95% CI 13 to 18), length of stay in the intensive care unit (MD 4.5 days, 95% CI 3.6 to 5.4) and length of stay in hospital (MD 4.4 days, 95% CI 3.4 to 5.5). Weaning duration decreased in the subgroup of patients with known weaning difficulty. The other outcomes weren't significantly affected or weren't measured.
CONCLUSION
Inspiratory muscle training for selected patients in the intensive care unit facilitates weaning, with potential reductions in length of stay and the duration of non-invasive ventilatory support after extubation. The heterogeneity among the results suggests that the effects of inspiratory muscle training may vary; this perhaps depends on factors such as the components of usual care or the patient's characteristics.
Topics: Humans; Inhalation; Intensive Care Units; Physical Therapy Modalities; Respiration, Artificial; Respiratory Muscles; Ventilator Weaning
PubMed: 26092389
DOI: 10.1016/j.jphys.2015.05.016 -
Critical Care (London, England) Oct 2016Ventilator-dependent patients in the ICU often experience difficulties with one of the most basic human functions, namely communication, due to intubation. Although... (Review)
Review
BACKGROUND
Ventilator-dependent patients in the ICU often experience difficulties with one of the most basic human functions, namely communication, due to intubation. Although various assistive communication tools exist, these are infrequently used in ICU patients. We summarized the current evidence on communication methods with mechanically ventilated patients in the ICU. Secondly, we developed an algorithm for communication with these patients based on current evidence.
METHODS
We performed a systematic review. PubMed, Embase, Cochrane, Cinahl, PsychInfo, and Web of Science databases were systematically searched to November 2015. Studies that reported a communication intervention with conscious nonverbal mechanically ventilated patients in the ICU aged 18 years or older were included. The methodological quality was assessed using the Quality Assessment Tool.
RESULTS
The search yielded 9883 publications, of which 31 articles, representing 29 different studies, fulfilled the inclusion criteria. The overall methodological quality varied from poor to moderate. We identified four communication intervention types: (1) communication boards were studied in three studies-they improved communication and increased patient satisfaction, but they can be time-consuming and limit the ability to produce novel utterances; (2) two types of specialized talking tracheostomy tubes were assessed in eight studies-audible voicing was achieved in the majority of patients (range 74-100 %), but more studies are needed to facilitate safe and effective use; (3) an electrolarynx improved communication in seven studies-its effectiveness was mainly demonstrated with tracheostomized patients; and (4) "high-tech" augmentative and alternative communication (AAC) devices in nine studies with diverse computerized AAC devices proved to be beneficial communication methods-two studies investigated multiple AAC interventions, and different control devices (e.g., touch-sensitive or eye/blink detection) can be used to ensure that physical limitations do not prevent use of the devices. We developed an algorithm for the assessment and selection of a communication intervention with nonverbal and conscious mechanically intubated patients in the ICU.
CONCLUSIONS
Although evidence is limited, results suggest that most communication methods may be effective in improving patient-healthcare professional communication with mechanically ventilated patients. A combination of methods is advised. We developed an algorithm to standardize the approach for selection of communication techniques.
Topics: Communication; Consciousness; Critical Illness; Humans; Intensive Care Units; Intubation, Intratracheal; Respiration, Artificial
PubMed: 27756433
DOI: 10.1186/s13054-016-1483-2 -
The Cochrane Database of Systematic... Jan 2017Motor neuron disease (MND), which is also known as amyotrophic lateral sclerosis (ALS), causes a wide range of symptoms but the evidence base for the effectiveness of... (Review)
Review
BACKGROUND
Motor neuron disease (MND), which is also known as amyotrophic lateral sclerosis (ALS), causes a wide range of symptoms but the evidence base for the effectiveness of the symptomatic treatment therapies is limited.
OBJECTIVES
To summarise the evidence from Cochrane Systematic Reviews of all symptomatic treatments for MND.
METHODS
We searched the Cochrane Database of Systematic Reviews (CDSR) on 15 November 2016 for systematic reviews of symptomatic treatments for MND. We assessed the methodological quality of the included reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the GRADE approach. We followed standard Cochrane study (review) selection and data extraction procedures. We reported findings narratively and in tables.
MAIN RESULTS
We included nine Cochrane Systematic Reviews of interventions to treat symptoms in people with MND. Three were empty reviews with no included randomised controlled trials (RCTs); however, all three reported on non-RCT evidence and the remaining six included mostly one or two studies. We deemed all of the included reviews of high methodological quality. Drug therapy for painThere is no RCT evidence in a Cochrane Systematic Review exploring the efficacy of drug therapy for pain in MND. Treatment for crampsThere is evidence (13 RCTs, N = 4012) that for the treatment of cramps in MND, compared to placebo:- memantine and tetrahydrocannabinol (THC) are probably ineffective (moderate-quality evidence);- vitamin E may have little or no effect (low-quality evidence); and- the effects of L-threonine, gabapentin, xaliproden, riluzole, and baclofen are uncertain as the evidence is either very low quality or the trial specified the outcome but did not report numerical data.The review reported adverse effects of riluzole, but it is not clear whether other interventions had adverse effects. Treatment for spasticityIt is uncertain whether an endurance-based exercise programme improved spasticity or quality of life, measured at three months after the programme, as the quality of evidence is very low (1 RCT, comparison "usual activities", N = 25). The review did not evaluate other approaches, such as use of baclofen as no RCTs were available. Mechanical ventilation for supporting respiratory functionNon-invasive ventilation (NIV) probably improves median survival and quality of life in people with respiratory insufficiency and normal to moderately impaired bulbar function compared to standard care, and improves quality of life but not survival for people with poor bulbar function (1 RCT, N = 41, moderate-quality evidence; a second RCT did not provide data). The review did not evaluate other approaches such as tracheostomy-assisted ('invasive') ventilation, or assess timing of NIV initiation. Treatment for sialorrhoeaA single session of botulinum toxin type B injections to parotid and submandibular glands probably improves sialorrhoea and quality of life at up to 4 weeks compared to placebo injections, but not at 8 or 12 weeks after the injections (moderate-quality evidence from 1 placebo-controlled RCT, N = 20). The review authors found no trials of other approaches. Enteral tube feeding for supporting nutritionThere is no RCT evidence in a Cochrane Systematic Review to support benefit or harms of enteral tube feeding in supporting nutrition in MND. Repetitive transcranial magnetic stimulationIt is uncertain whether repetitive transcranial magnetic stimulation (rTMS) improves disability or limitation in activity in MND in comparison with sham rTMS (3 RCTs, very low quality evidence, N = 50). Therapeutic exerciseThere is evidence that exercise may improve disability in MND at three months after the exercise programme, but not quality of life, in comparison with "usual activities" or "usual care" including stretching (2 RCTs, low-quality evidence, N = 43). Multidisciplinary careThere is no RCT evidence in a Cochrane Systematic Review to demonstrate any benefit or harm for multidisciplinary care in MND.None of the reviews, other than the review of treatment for cramps, reported that adverse events occurred. However, the trials were too small for reliable adverse event reporting.
AUTHORS' CONCLUSIONS
This overview has highlighted the lack of robust evidence in Cochrane Systematic Reviews on interventions to manage symptoms resulting from MND. It is important to recognise that clinical trials may fail to demonstrate efficacy of an intervention for reasons other than a true lack of efficacy, for example because of insufficient statistical power, the wrong choice of dose, insensitive outcome measures or inappropriate participant eligibility. The trials were mostly too small to reliably assess adverse effects of the treatments. The nature of MND makes it difficult to research clinically accepted or recommended practice, regardless of the level of evidence supporting the practice. It would not be ethical, for example, to design a placebo-controlled trial for treatment of pain in MND or to withhold multidisciplinary care where such care is available. It is therefore highly unlikely that there will ever be classically designed placebo-controlled RCTs in these areas.We need more research with appropriate study designs, robust methodology, and of sufficient duration to address the changing needs-of people with MND and their caregivers-associated with MND disease progression and mortality. There is a significant gap in studies assessing the effectiveness of interventions for symptoms relating to MND, such as pseudobulbar emotional lability and cognitive and behavioural difficulties. Future studies should use appropriate outcome measures that are reliable, have internal and external validity, and are sensitive to change in what is being measured (such as quality of life).
Topics: Amyotrophic Lateral Sclerosis; Enteral Nutrition; Exercise Therapy; Humans; Motor Neuron Disease; Muscle Cramp; Muscle Spasticity; Noninvasive Ventilation; Pain; Respiratory Insufficiency; Review Literature as Topic; Sialorrhea; Transcranial Magnetic Stimulation
PubMed: 28072907
DOI: 10.1002/14651858.CD011776.pub2 -
The Cochrane Database of Systematic... Jan 2017There are various reasons why weaning and extubation failure occur, but ineffective cough and secretion retention can play a significant role. Cough augmentation... (Review)
Review
BACKGROUND
There are various reasons why weaning and extubation failure occur, but ineffective cough and secretion retention can play a significant role. Cough augmentation techniques, such as lung volume recruitment or manually- and mechanically-assisted cough, are used to prevent and manage respiratory complications associated with chronic conditions, particularly neuromuscular disease, and may improve short- and long-term outcomes for people with acute respiratory failure. However, the role of cough augmentation to facilitate extubation and prevent post-extubation respiratory failure is unclear.
OBJECTIVES
Our primary objective was to determine extubation success using cough augmentation techniques compared to no cough augmentation for critically-ill adults and children with acute respiratory failure admitted to a high-intensity care setting capable of managing mechanically-ventilated people (such as an intensive care unit, specialized weaning centre, respiratory intermediate care unit, or high-dependency unit).Secondary objectives were to determine the effect of cough augmentation techniques on reintubation, weaning success, mechanical ventilation and weaning duration, length of stay (high-intensity care setting and hospital), pneumonia, tracheostomy placement and tracheostomy decannulation, and mortality (high-intensity care setting, hospital, and after hospital discharge). We evaluated harms associated with use of cough augmentation techniques when applied via an artificial airway (or non-invasive mask once extubated/decannulated), including haemodynamic compromise, arrhythmias, pneumothorax, haemoptysis, and mucus plugging requiring airway change and the type of person (such as those with neuromuscular disorders or weakness and spinal cord injury) for whom these techniques may be efficacious.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4, 2016), MEDLINE (OvidSP) (1946 to April 2016), Embase (OvidSP) (1980 to April 2016), CINAHL (EBSCOhost) (1982 to April 2016), and ISI Web of Science and Conference Proceedings. We searched the PROSPERO and Joanna Briggs Institute databases, websites of relevant professional societies, and conference abstracts from five professional society annual congresses (2011 to 2015). We did not impose language or other restrictions. We performed a citation search using PubMed and examined reference lists of relevant studies and reviews. We contacted corresponding authors for details of additional published or unpublished work. We searched for unpublished studies and ongoing trials on the International Clinical Trials Registry Platform (apps.who.int/trialsearch) (April 2016).
SELECTION CRITERIA
We included randomized and quasi-randomized controlled trials that evaluated cough augmentation compared to a control group without this intervention. We included non-randomized studies for assessment of harms. We included studies of adults and of children aged four weeks or older, receiving invasive mechanical ventilation in a high-intensity care setting.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts identified by our search methods. Two review authors independently evaluated full-text versions, independently extracted data and assessed risks of bias.
MAIN RESULTS
We screened 2686 citations and included two trials enrolling 95 participants and one cohort study enrolling 17 participants. We assessed one randomized controlled trial as being at unclear risk of bias, and the other at high risk of bias; we assessed the non-randomized study as being at high risk of bias. We were unable to pool data due to the small number of studies meeting our inclusion criteria and therefore present narrative results rather than meta-analyses. One trial of 75 participants reported that extubation success (defined as no need for reintubation within 48 hours) was higher in the mechanical insufflation-exsufflation (MI-E) group (82.9% versus 52.5%, P < 0.05) (risk ratio (RR) 1.58, 95% confidence interval (CI) 1.13 to 2.20, very low-quality evidence). No study reported weaning success or reintubation as distinct from extubation success. One trial reported a statistically significant reduction in mechanical ventilation duration favouring MI-E (mean difference -6.1 days, 95% CI -8.4 to -3.8, very low-quality evidence). One trial reported mortality, with no participant dying in either study group. Adverse events (reported by two trials) included one participant receiving the MI-E protocol experiencing haemodynamic compromise. Nine (22.5%) of the control group compared to two (6%) MI-E participants experienced secretion encumbrance with severe hypoxaemia requiring reintubation (RR 0.25, 95% CI 0.06 to 1.10). In the lung volume recruitment trial, one participant experienced an elevated blood pressure for more than 30 minutes. No participant experienced new-onset arrhythmias, heart rate increased by more than 25%, or a pneumothorax.For outcomes assessed using GRADE, we based our downgrading decisions on unclear risk of bias, inability to assess consistency or publication bias, and uncertainty about the estimate of effect due to the limited number of studies contributing outcome data.
AUTHORS' CONCLUSIONS
The overall quality of evidence on the efficacy of cough augmentation techniques for critically-ill people is very low. Cough augmentation techniques when used in mechanically-ventilated critically-ill people appear to result in few adverse events.
Topics: Adult; Airway Extubation; Cohort Studies; Cough; Critical Illness; Humans; Infant; Insufflation; Intensive Care Units; Length of Stay; Randomized Controlled Trials as Topic; Ventilator Weaning
PubMed: 28075489
DOI: 10.1002/14651858.CD011833.pub2 -
The Cochrane Database of Systematic... May 2022Motor neuron disease (MND), also known as amyotrophic lateral sclerosis (ALS), is a progressive neurodegenerative condition that may cause dysphagia, as well as limb... (Review)
Review
BACKGROUND
Motor neuron disease (MND), also known as amyotrophic lateral sclerosis (ALS), is a progressive neurodegenerative condition that may cause dysphagia, as well as limb weakness, dysarthria, emotional lability, and respiratory failure. Since normal salivary production is 0.5 L to 1.5 L daily, loss of salivary clearance due to dysphagia leads to salivary pooling and sialorrhea, often resulting in distress and inconvenience to people with MND. This is an update of a review first published in 2011.
OBJECTIVES
To assess the effects of treatments for sialorrhea in MND, including medications, radiotherapy and surgery.
SEARCH METHODS
On 27 August 2021, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, ClinicalTrials.gov and the WHO ICTRP. We checked the bibliographies of the identified randomized trials and contacted trial authors as needed. We contacted known experts in the field to identify further published and unpublished papers.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs, including cross-over trials, on any intervention for sialorrhea and related symptoms, compared with each other, placebo or no intervention, in people with ALS/MND.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified four RCTs involving 110 participants with MND who were described as having intractable sialorrhea or bulbar dysfunction. A well-designed study of botulinum toxin B compared to placebo injected into the parotid and submandibular glands of 20 participants showed that botulinum toxin B may produce participant-reported improvement in sialorrhea, but the confidence interval (CI) was also consistent with no effect. Six of nine participants in the botulinum group and two of nine participants in the placebo group reported improvement (risk ratio (RR) 3.00, 95% CI 0.81 to 11.08; 1 RCT; 18 participants; low-certainty evidence). An objective measure indicated that botulinum toxin B probably reduced saliva production (in mL/5 min) at eight weeks compared to placebo (MD -0.50, 95% CI -1.07 to 0.07; 18 participants, moderate-certainty evidence). Botulinum toxin B may have little to no effect on quality of life, measured on the Schedule for Evaluation of Individual Quality of Life direct weighting scale (SEIQoL-DW; 0-100, higher values indicate better quality of life) (MD -2.50, 95% CI -17.34 to 12.34; 1 RCT; 17 participants; low-certainty evidence). The rate of adverse events may be similar with botulinum toxin B and placebo (20 participants; low-certainty evidence). Trialists did not consider any serious events to be related to treatment. A randomized pilot study of botulinum toxin A or radiotherapy in 20 participants, which was at high risk of bias, provided very low-certainty evidence on the primary outcome of the Drool Rating Scale (DRS; range 8 to 39 points, higher scores indicate worse drooling) at 12 weeks (effect size -4.8, 95% CI -10.59 to 0.92; P = 0.09; 1 RCT; 16 participants). Quality of life was not measured. Evidence for adverse events, measured immediately after treatment (RR 7.00, 95% CI 1.04 to 46.95; 20 participants), and after four weeks (when two people in each group had viscous saliva) was also very uncertain. A phase 2, randomized, placebo-controlled cross-over study of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate (DMQ) found that DMQ may produce a participant-reported improvement in sialorrhea, indicated by a slight improvement (decrease) in mean scores for the primary outcome, the Center for Neurologic Study Bulbar Function Scale (CNS-BFS). Mean total CNS-BFS (range 21 (no symptoms) to 112 (maximum symptoms)) was 53.45 (standard error (SE) 1.07) for the DMQ treatment period and 59.31 (SE 1.10) for the placebo period (mean difference) MD -5.85, 95% CI -8.77 to -2.93) with a slight decrease in the CNS-BFS sialorrhea subscale score (range 7 (no symptoms) to 35 (maximum symptoms)) compared to placebo (MD -1.52, 95% CI -2.52 to -0.52) (1 RCT; 60 participants; moderate-certainty evidence). The trial did not report an objective measure of saliva production or measure quality of life. The study was at an unclear risk of bias. Adverse events were similar to other trials of DMQ, and may occur at a similar rate as placebo (moderate-certainty evidence, 60 participants), with the most common side effects being constipation, diarrhea, nausea, and dizziness. Nausea and diarrhea on DMQ treatment resulted in one withdrawal. A randomized, double-blind, placebo-controlled cross-over study of scopolamine (hyoscine), administered using a skin patch, involved 10 randomized participants, of whom eight provided efficacy data. The participants were unrepresentative of clinic cohorts under routine clinical care as they had feeding tubes and tracheostomy ventilation, and the study was at high risk of bias. The trial provided very low-certainty evidence on sialorrhea in the short term (7 days' treatment, measured on the Amyotrophic Lateral Scelerosis Functional Rating Scale-Revised (ALSFRS-R) saliva item (P = 0.572)), and the amount of saliva production in the short term, as indicated by the weight of a cotton roll (P = 0.674), or daily oral suction volume (P = 0.69). Quality of life was not measured. Adverse events evidence was also very uncertain. One person treated with scopolamine had a dry mouth and one died of aspiration pneumonia considered unrelated to treatment.
AUTHORS' CONCLUSIONS
There is some low-certainty or moderate-certainty evidence for the use of botulinum toxin B injections to salivary glands and moderate-certainty evidence for the use of oral dextromethorphan with quinidine (DMQ) for the treatment of sialorrhea in MND. Evidence on radiotherapy versus botulinum toxin A injections, and scopolamine patches is too uncertain for any conclusions to be drawn. Further research is required on treatments for sialorrhea. Data are needed on the problem of sialorrhea in MND and its measurement, both by participant self-report measures and objective tests. These will allow the development of better RCTs.
Topics: Amyotrophic Lateral Sclerosis; Botulinum Toxins, Type A; Clinical Trials, Phase II as Topic; Deglutition Disorders; Diarrhea; Humans; Motor Neuron Disease; Nausea; Randomized Controlled Trials as Topic; Saliva; Scopolamine Derivatives; Sialorrhea
PubMed: 35593746
DOI: 10.1002/14651858.CD006981.pub3 -
Medicine Mar 2023Post-extubation dysphagia is high in critically ill patients and is not easily recognized. This study aimed to identify risk factors for acquired swallowing disorders in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Post-extubation dysphagia is high in critically ill patients and is not easily recognized. This study aimed to identify risk factors for acquired swallowing disorders in the intensive care unit (ICU).
METHODS
We have retrieved all relevant research published before August 2022 from PubMed, Embase, Web of Science, and the Cochrane Library electronic databases. The studies were selected using inclusion and exclusion criteria. Two reviewers screened studies, extracted data, and independently evaluated the risk of bias. The quality of the study was assessed with the Newcastle-Ottawa Scale, and a meta-analysis was carried out with Cochrane Collaboration's Revman 5.3 software.
RESULTS
A total of 15 studies were included. Age (odds ratio [OR] = 1.04), tracheal intubation time (OR = 1.61), APACHE II (OR = 1.04), and tracheostomy (OR = 3.75) were significant risk factors that contributed to post-extubation dysphagia in ICU.
CONCLUSION
This study provides preliminary evidence that post-extraction dysphagia in ICU is associated with factors such as age, tracheal intubation time, APACHE II, and tracheostomy. The results of this research may improve clinician awareness, risk stratification, and prevention of post-extraction dysphagia in the ICU.
Topics: Humans; Deglutition Disorders; Airway Extubation; Intensive Care Units; Intubation, Intratracheal; Critical Illness; Risk Factors
PubMed: 36897733
DOI: 10.1097/MD.0000000000033153 -
The Cochrane Database of Systematic... Aug 2019Hospital-acquired infection is a frequent adverse event in patient care; it can lead to longer stays in the intensive care unit (ICU), additional medical complications,...
BACKGROUND
Hospital-acquired infection is a frequent adverse event in patient care; it can lead to longer stays in the intensive care unit (ICU), additional medical complications, permanent disability or death. Whilst all hospital-based patients are susceptible to infections, prevalence is particularly high in the ICU, where people who are critically ill have suppressed immunity and are subject to increased invasive monitoring. People who are mechanically-ventilated are at infection risk due to tracheostomy and reintubation and use of multiple central venous catheters, where lines and tubes may act as vectors for the transmission of bacteria and may increase bloodstream infections and ventilator-associated pneumonia (VAP). Chlorhexidine is a low-cost product, widely used as a disinfectant and antiseptic, which may be used to bathe people who are critically ill with the aim of killing bacteria and reducing the spread of hospital-acquired infections.
OBJECTIVES
To assess the effects of chlorhexidine bathing on the number of hospital-acquired infections in people who are critically ill.
SEARCH METHODS
In December 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared chlorhexidine bathing with soap-and-water bathing of patients in the ICU.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and undertook risk of bias and GRADE assessment of the certainty of the evidence .
MAIN RESULTS
We included eight studies in this review. Four RCTs included a total of 1537 individually randomised participants, and four cluster-randomised cross-over studies included 23 randomised ICUs with 22,935 participants. We identified one study awaiting classification, for which we were unable to assess eligibility.The studies compared bathing using 2% chlorhexidine-impregnated washcloths or dilute solutions of 4% chlorhexidine versus soap-and-water bathing or bathing with non-antimicrobial washcloths.Eight studies reported data for participants who had a hospital-acquired infection during the ICU stay. We are uncertain whether using chlorhexidine for bathing of critically ill people reduces the rate of hospital-acquired infection, because the certainty of the evidence is very low (rate difference 1.70, 95% confidence interval (CI) 0.12 to 3.29; 21,924 participants). Six studies reported mortality (in hospital, in the ICU, and at 48 hours). We cannot be sure whether using chlorhexidine for bathing of critically-ill people reduces mortality, because the certainty of the evidence is very low (odds ratio 0.87, 95% CI 0.76 to 0.99; 15,798 participants). Six studies reported length of stay in the ICU. We noted that individual studies found no evidence of a difference in length of stay; we did not conduct meta-analysis because data were skewed. It is not clear whether using chlorhexidine for bathing of critically ill people reduced length of stay in the ICU, because the certainty of the evidence is very low. Seven studies reported skin reactions as an adverse event, and five of these reported skin reactions which were thought to be attributable to the bathing solution. Data in these studies were reported inconsistently and we were unable to conduct meta-analysis; we cannot tell whether using chlorhexidine for bathing of critically ill people reduced adverse events, because the certainty of the evidence is very low.We used the GRADE approach to downgrade the certainty of the evidence of each outcome to very low. For all outcomes, we downgraded evidence because of study limitations (most studies had a high risk of performance bias, and we noted high risks of other bias in some studies). We downgraded evidence due to indirectness, because some participants in studies may have had hospital-acquired infections before recruitment. We noted that one small study had a large influence on the effect for hospital-acquired infections, and we assessed decisions made in analysis of some cluster-randomised cross-over studies on the effect for hospital-acquired infections and for mortality; we downgraded the evidence for these outcomes due to inconsistency. We also downgraded the evidence on length of stay in the ICU, because of imprecision. Data for adverse events were limited by few events and so we downgraded for imprecision.
AUTHORS' CONCLUSIONS
Due to the very low-certainty evidence available, it is not clear whether bathing with chlorhexidine reduces hospital-acquired infections, mortality, or length of stay in the ICU, or whether the use of chlorhexidine results in more skin reactions.
Topics: Anti-Infective Agents, Local; Baths; Central Venous Catheters; Chlorhexidine; Critical Illness; Cross Infection; Humans; Pneumonia, Ventilator-Associated; Randomized Controlled Trials as Topic; Sepsis
PubMed: 31476022
DOI: 10.1002/14651858.CD012248.pub2 -
The British Journal of Oral &... Nov 2021A systematic review and meta-analysis of the entire COVID-19 Tracheostomy cohort was conducted to determine the cumulative incidence of complications, mortality, time to... (Meta-Analysis)
Meta-Analysis Review
A systematic review and meta-analysis of the entire COVID-19 Tracheostomy cohort was conducted to determine the cumulative incidence of complications, mortality, time to decannulation and ventilatory weaning. Outcomes of surgical versus percutaneous and outcomes relative to tracheostomy timing were also analysed. Studies reporting outcome data on patients with COVID-19 undergoing tracheostomy were identified and screened by 2 independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed. Outcome data were analysed using a random-effects model. From 1016 unique studies, 39 articles reporting outcomes for a total of 3929 patients were included for meta-analysis. Weighted mean follow-up time was 42.03±26 days post-tracheostomy. Meta-analysis showed that 61.2% of patients were weaned from mechanical ventilation [95%CI 52.6%-69.5%], 44.2% of patients were decannulated [95%CI 33.96%-54.67%], and cumulative mortality was found to be 19.23% [95%CI 15.2%-23.6%] across the entire tracheostomy cohort. The cumulative incidence of complications was 14.24% [95%CI 9.6%-19.6%], with bleeding accounting for 52% of all complications. No difference was found in incidence of mortality (RR1.96; p=0.34), decannulation (RR1.35, p=0.27), complications (RR0.75, p=0.09) and time to decannulation (SMD 0.46, p=0.68) between percutaneous and surgical tracheostomy. Moreover, no difference was found in mortality (RR1.57, p=0.43) between early and late tracheostomy, and timing of tracheostomy did not predict time to decannulation. Ten confirmed nosocomial staff infections were reported from 1398 tracheostomies. This study provides an overview of outcomes of tracheostomy in COVID-19 patients, and contributes to our understanding of tracheostomy decisions in this patient cohort.
Topics: COVID-19; Cohort Studies; Humans; Respiration, Artificial; SARS-CoV-2; Tracheostomy
PubMed: 34294476
DOI: 10.1016/j.bjoms.2021.05.011