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Critical Care (London, England) Mar 2013Randomized trials investigating neuromuscular blocking agents in adult acute respiratory distress syndrome (ARDS) have been inconclusive about effects on mortality,... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Randomized trials investigating neuromuscular blocking agents in adult acute respiratory distress syndrome (ARDS) have been inconclusive about effects on mortality, which is very high in this population. Uncertainty also exists about the associated risk of ICU-acquired weakness.
METHODS
We conducted a systematic review and meta-analysis. We searched the Cochrane (Central) database, MEDLINE, EMBASE, ACP Journal Club, and clinical trial registries for randomized trials investigating survival effects of neuromuscular blocking agents in adults with ARDS. Two independent reviewers abstracted data and assessed methodologic quality. Primary study investigators provided additional unpublished data.
RESULTS
Three trials (431 patients; 20 centers; all from the same research group in France) met inclusion criteria for this review. All trials assessed 48-hour infusions of cisatracurium besylate. Short-term infusion of cisatracurium besylate was associated with lower hospital mortality (RR, 0.72; 95% CI, 0.58 to 0.91; P=0.005; I2=0). This finding was robust on sensitivity analyses. Neuromuscular blockade was also associated with lower risk of barotrauma (RR, 0.43; 95% CI, 0.20 to 0.90; P=0.02; I2=0), but had no effect on the duration of mechanical ventilation among survivors (MD, 0.25 days; 95% CI, 5.48 to 5.99; P=0.93; I2=49%), or the risk of ICU-acquired weakness (RR, 1.08; 95% CI, 0.83 to 1.41; P=0.57; I2=0). Primary studies lacked protracted measurements of weakness.
CONCLUSIONS
Short-term infusion of cisatracurium besylate reduces hospital mortality and barotrauma and does not appear to increase ICU-acquired weakness for critically ill adults with ARDS.
Topics: Atracurium; Humans; Neuromuscular Blocking Agents; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Distress Syndrome
PubMed: 23497608
DOI: 10.1186/cc12557 -
The Cochrane Database of Systematic... Nov 2012Asthma is the most common chronic disease in children, and children with asthma frequently visit the paediatric emergency departments with acute exacerbations. Some of... (Review)
Review
BACKGROUND
Asthma is the most common chronic disease in children, and children with asthma frequently visit the paediatric emergency departments with acute exacerbations. Some of these children fail to respond to standard therapy (aerosol beta(2)-agonist with or without aerosol anticholinergic and oral or parenteral corticosteroids) for acute asthma leading to prolonged emergency department stay, hospitalisation, morbidity (e.g. barotrauma, intubation) and death, albeit rarely. Ketamine may relieve bronchospasm and is a potentially promising therapy for children with acute asthma who fail to respond to standard treatment.
OBJECTIVES
To evaluate the efficacy of ketamine compared to placebo, no intervention or standard care for management of severe acute asthma in children who had not responded to standard therapy.
SEARCH METHODS
We identified trials from the Cochrane Airways Group Specialised Register of trials (CAGR) and ClinicalTrials.gov. We reviewed reference lists of all primary studies and review articles for additional references. We contacted authors of identified trials and asked them to identify other published and unpublished studies. The latest search was in July 2012.
SELECTION CRITERIA
Randomised controlled trials comparing ketamine to placebo or standard care in children (up to 18 years of age) presenting with an acute asthma exacerbation who had not responded to standard therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies. The data were extracted in pre-defined proforma and were analysed independently by two review authors. The data analysis was performed using Review Manager 5.1.
MAIN RESULTS
A single study enrolling 68 non-intubated children was found eligible for inclusion in review. The study had low or unclear risk of bias. It demonstrated no significant difference in respiratory rate, oxygen saturation, hospital admission rate (odds ratio (OR) 0.77; 95% confidence interval (CI) 0.23 to 2.58) and need for mechanical ventilation between ketamine (0.2 mg/kg intravenous bolus over one to two minutes, followed by a 0.5 mg/kg per hour continuous infusion for two hours) and placebo group. There were no significant side effects of ketamine in the study. There was also no difference in need for other adjuvant therapy (OR 2.19; 95% CI 0.19 to 25.40) and in Pulmonary Index Score (mean difference (MD) -0.40; 95% CI -1.21 to 0.41) between the groups.
AUTHORS' CONCLUSIONS
The single study on non-intubated children with severe acute asthma did not show significant benefit and does not support the case studies and observational reports showing benefits of ketamine in both non-ventilated and ventilated children. There were no significant side effects of ketamine. We could not find any trials on ventilated children. To prove that ketamine is an effective treatment for acute asthma in children, there is need for sufficiently powered randomised trials of high methodological quality with objective outcome measures of clinical importance. Future trials should also explore different doses of ketamine and its role in children needing ventilation because of severe acute asthma.
Topics: Acute Disease; Adolescent; Asthma; Bronchodilator Agents; Child; Child, Preschool; Disease Progression; Humans; Infant; Ketamine; Randomized Controlled Trials as Topic; Respiration, Artificial
PubMed: 23152273
DOI: 10.1002/14651858.CD009293.pub2 -
The Cochrane Database of Systematic... May 2012Decompression illness (DCI) is due to bubble formation in the blood or tissues following the breathing of compressed gas. Clinically, DCI may range from a trivial... (Review)
Review
BACKGROUND
Decompression illness (DCI) is due to bubble formation in the blood or tissues following the breathing of compressed gas. Clinically, DCI may range from a trivial illness to loss of consciousness, death or paralysis. Recompression is the universally accepted standard treatment of DCI. When recompression is delayed, a number of strategies have been suggested in order to improve the outcome.
OBJECTIVES
To examine the effectiveness and safety of both recompression and adjunctive therapies in the treatment of DCI.
SEARCH METHODS
In our previous update we searched until October 2009. In this version we searched CENTRAL (The Cochrane Library, October 2011); MEDLINE (1966 to October 2011); CINAHL (1982 to October 2011); EMBASE (1980 to October 2011); the Database of Randomised Controlled Trials in Hyperbaric Medicine (October 2011); and handsearched journals and texts.
SELECTION CRITERIA
We included randomized controlled trials that compared the effect of any recompression schedule or adjunctive therapy with a standard recompression schedule. We did not apply language restrictions.
DATA COLLECTION AND ANALYSIS
Three authors extracted the data independently. We assessed each trial for internal validity and resolved differences by discussion. Data were entered into RevMan 5.1.
MAIN RESULTS
Two randomized controlled trials enrolling a total of 268 patients satisfied the inclusion criteria. The risk of bias for Drewry 1994 was unclear as this study was presented as an abstract, while Bennett 2003 was rated as at low risk. Pooling of data was not possible. In one study there was no evidence of improved effectiveness with the addition of a non-steroidal anti-inflammatory drug (tenoxicam) to routine recompression therapy (at six weeks: relative risk (RR) 1.04, 95% confidence interval (CI) 0.90 to 1.20, P = 0.58) but there was a reduction in the number of compressions required when tenoxicam was added from three to two (P = 0.01, 95% CI 0 to 1). In the other study, the odds of multiple recompressions were lower with a helium and oxygen (heliox) table compared to an oxygen treatment table (RR 0.56, 95% CI 0.31 to 1.00, P = 0.05).
AUTHORS' CONCLUSIONS
Recompression therapy is standard for the treatment of DCI, but there is no randomized controlled trial evidence for its use. Both the addition of a non-steroidal anti-inflammatory drug (NSAID) and the use of heliox may reduce the number of recompressions required, but neither improve the odds of recovery. The application of either of these strategies may be justified. The modest number of patients studied demands a cautious interpretation. Benefits may be largely economic and an economic analysis should be undertaken. There is a case for large randomized trials of high methodological rigour in order to define any benefit from the use of different breathing gases and pressure profiles during recompression therapy.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Decompression Sickness; Humans; Hyperbaric Oxygenation; Piroxicam; Randomized Controlled Trials as Topic; Retreatment
PubMed: 22592704
DOI: 10.1002/14651858.CD005277.pub3 -
PloS One Jan 2011Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are life threatening clinical conditions seen in critically ill patients with diverse underlying... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are life threatening clinical conditions seen in critically ill patients with diverse underlying illnesses. Lung injury may be perpetuated by ventilation strategies that do not limit lung volumes and airway pressures. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing pressure and volume-limited (PVL) ventilation strategies with more traditional mechanical ventilation in adults with ALI and ARDS.
METHODS AND FINDINGS
We searched Medline, EMBASE, HEALTHSTAR and CENTRAL, related articles on PubMed™, conference proceedings and bibliographies of identified articles for randomized trials comparing PVL ventilation with traditional approaches to ventilation in critically ill adults with ALI and ARDS. Two reviewers independently selected trials, assessed trial quality, and abstracted data. We identified ten trials (n = 1,749) meeting study inclusion criteria. Tidal volumes achieved in control groups were at the lower end of the traditional range of 10-15 mL/kg. We found a clinically important but borderline statistically significant reduction in hospital mortality with PVL [relative risk (RR) 0.84; 95% CI 0.70, 1.00; p = 0.05]. This reduction in risk was attenuated (RR 0.90; 95% CI 0.74, 1.09, p = 0.27) in a sensitivity analysis which excluded 2 trials that combined PVL with open-lung strategies and stopped early for benefit. We found no effect of PVL on barotrauma; however, use of paralytic agents increased significantly with PVL (RR 1.37; 95% CI, 1.04, 1.82; p = 0.03).
CONCLUSIONS
This systematic review suggests that PVL strategies for mechanical ventilation in ALI and ARDS reduce mortality and are associated with increased use of paralytic agents.
Topics: Acute Lung Injury; Humans; Pressure; Respiration, Artificial; Respiratory Distress Syndrome
PubMed: 21298026
DOI: 10.1371/journal.pone.0014623 -
Respiratory Care May 2011Studies of ventilation strategies that included higher PEEP in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) have yielded... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Studies of ventilation strategies that included higher PEEP in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) have yielded conflicting results.
OBJECTIVE
To determine whether higher PEEP during volume-limited and pressure-limited ventilation is associated with 28-day mortality or barotrauma rates in patients with ALI/ARDS.
METHODS
We searched MEDLINE, CENTRAL, EMBASE, CINAHL, Web of Science, and the bibliographies of retrieved papers to identify randomized controlled trials that compared higher and lower PEEP in adult patients with ALI/ARDS who were already receiving volume-limited or pressure-limited ventilation. Two of us independently abstracted study-level data, including study design, patient characteristics, study methods, intervention, and main results. We pooled the study-level data with a random-effects model, unless heterogeneity was low (I(2) < 50%), in which case we used a fixed-effects model. The primary outcome was 28-day mortality.
RESULTS
Four randomized trials (2,360 participants) were evaluated. Higher PEEP had a nonsignificant trend toward lower 28-day mortality (pooled relative risk 0.90, 95% CI 0.79-1.02). There was no difference in barotrauma between the 2 groups (pooled relative risk 1.17, 95% CI 0.90-1.52). Two studies reported an adjusted hospital death rate, and the pooled results of sensitivity analysis with those adjusted rates were identical to those of the unadjusted analysis.
CONCLUSIONS
In 4 recent studies that used volume-limited or pressure-limited ventilation in ALI/ARDS patients, higher PEEP was not associated with significantly different short-term mortality or barotrauma. This study does not support the routine use of higher PEEP in patients with ALI/ARDS.
Topics: Acute Lung Injury; Humans; Positive-Pressure Respiration; Practice Guidelines as Topic; Survival Rate; United States
PubMed: 21276322
DOI: 10.4187/respcare.01011 -
Anesthesiology May 2009Positive end expiratory pressure (PEEP) is an important component of therapy in patients with acute lung injury or acute respiratory distress syndrome. The independent... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Positive end expiratory pressure (PEEP) is an important component of therapy in patients with acute lung injury or acute respiratory distress syndrome. The independent effect of PEEP on mortality is currently unknown.
METHODS
A systematic review and meta-analysis of randomized controlled clinical trials comparing the use of higher and lower levels of PEEP.
RESULTS
Six trials with a total of 2,484 patients from 102 intensive care units and 9 countries met the eligibility criteria. In three trials, the effect of different levels of PEEP was compared in groups receiving comparable tidal volumes. Three trials accounted for more than 85% of total weighting in the meta-analyses. The pooled relative risk obtained from these three trials showed a trend towards improved mortality with high PEEP, even though the difference did not reach statistical significance: Pooled cumulative risk of 0.90 (95% CI 0.72-1.02, P = 0.077). The reduction in absolute risk of death was approximately 4%. There was no evidence of a significant increase in baro-trauma in patients receiving high PEEP, with a pooled risk of 0.95 (95% CI 0.62-1.45, P = 0.81).
CONCLUSION
High PEEP strategy may have a clinically relevant independent mortality benefit. Despite a possible increase in baro-trauma, the benefits far outweigh potential risks. Current evidence therefore favors the use of high PEEP as the preferred option when ventilating patients with severe acute respiratory distress syndrome. As the reduction in absolute risk of death is less than 5%, a future clinical trial aimed at demonstrating statistical significance is likely to pose considerable financial and ethical burdens.
Topics: Humans; Positive-Pressure Respiration; Randomized Controlled Trials as Topic; Respiratory Distress Syndrome
PubMed: 19352160
DOI: 10.1097/ALN.0b013e31819fae06 -
Medicina Intensiva Dec 2007To perform a systematic review and meta-analysis of the literature to evaluate the effects of high PEEP versus conventional PEEP on mortality and on the risk of... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis of the literature to evaluate the effects of high PEEP versus conventional PEEP on mortality and on the risk of barotrauma in patients with the acute respiratory distress syndrome (ARDS).
SOURCE OF DATA
Computer search of Medline, Embase, CINAHL, CANCERLIT, Pascal-Biomed, ACP Journal Club, Cochrane library (CDSR, DARE, CCTR), ISI Proceedings, Current Contents, and Web of Science, as well as manual search of selected references.
SELECTION OF STUDIES
Controlled random clinical trials published after NAECC (1994) that evaluated the effect of two levels of PEEP and that reported the mortality and incidence of barotrauma in the series.
DATA EXTRACTION
By two investigators working independently, with discrepancies resolved by group consensus. Contingency tables were elaborated and the RRs with corresponding confidence intervals were obtained for each study.
RESULTS
Four articles were selected for the meta-analysis of mortality and three for the meta-analysis of barotrauma. No effects of PEEP level on mortality were found (RR 0.73, 95% CI: 0.49 to 1.10) or on the incidence of barotrauma (RR 0.50, 95% CI: 0.14 to 1.73). However, an analysis of the studies in which PEEP was individualized in function of Pflex showed a significant decrease in mortality (RR 0.59, 95% CI: 0.43 to 0.82) (p=0.001)
CONCLUSIONS
The use of high or conventional PEEP in function of oxygenation does not affect mortality or the incidence of barotrauma in patients with ARDS. However, there might be a decrease in mortality associated to high PEEP individualized in function of the pulmonary mechanics of each patient.
Topics: Humans; Positive-Pressure Respiration; Respiratory Distress Syndrome
PubMed: 18039449
DOI: 10.1016/s0210-5691(07)74856-8 -
BMJ Clinical Evidence Sep 2007Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children... (Review)
Review
INTRODUCTION
Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children might have damage to the ear drum after a flight, although perforation is rare. Symptoms usually resolve spontaneously.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent middle ear pain during air travel? We searched: Medline, Embase, The Cochrane Library and other important databases up to April 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 4 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: nasal balloon inflation, oral pseudoephedrine, and topical nasal decongestants.
Topics: Administration, Oral; Air Travel; Barotrauma; Ear, Middle; Earache; Humans; Incidence; Nasal Decongestants; Pain; Travel
PubMed: 19450303
DOI: No ID Found -
The Cochrane Database of Systematic... Apr 2005Ventilated newborn infants breathing in asynchrony with the ventilator are at risk for complications during mechanical ventilation, such as pneumothorax or... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Ventilated newborn infants breathing in asynchrony with the ventilator are at risk for complications during mechanical ventilation, such as pneumothorax or intraventricular hemorrhage, and are exposed to more severe barotrauma, which consequently could impair their clinical outcome. Neuromuscular paralysis, which eliminates spontaneous breathing efforts of the infant, has potential advantages in this respect. However, a number of complications have been reported with muscle relaxation in infants, so that concerns exist regarding the safety of prolonged neuromuscular paralysis in newborn infants.
OBJECTIVES
To determine whether routine neuromuscular paralysis of newborn infants receiving mechanical ventilation compared with no routine paralysis results in clinically important benefits or harms.
SEARCH STRATEGY
The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004), MEDLINE (from 1966 to April 2004) and EMBASE (from 1988 to April 2004) were searched. References of review articles were hand searched. Language restriction was not imposed.
SELECTION CRITERIA
All trials using random or quasi-random patient allocation, in which the routine use of neuromuscular blocking agents during mechanical ventilation was compared to no paralysis or selective paralysis in newborn infants. Methodological quality was assessed blindly and independently by the two authors.
DATA COLLECTION AND ANALYSIS
Data were abstracted using standard methods of the Cochrane Collaboration and its Neonatal Review Group, with independent evaluation of trial quality, and abstraction and synthesis of data by both authors. Treatment effect was analysed using relative risk, risk difference and weighted mean difference.
MAIN RESULTS
Ten possibly eligible trials were identified, of which six were included in the review. All the included trials studied preterm infants ventilated for respiratory distress syndrome, and used pancuronium as the neuromuscular blocking agent. In the analysis of the results of all trials, no significant difference was found in mortality, air leak or chronic lung disease, but there was a significant reduction in intraventricular hemorrhage and a trend towards less severe intraventricular hemorrhages. In the subgroup analysis of trials studying a selected population of ventilated infants with evidence of asynchronous respiratory efforts, a significant reduction in intraventricular hemorrhage (any grade and severe IVH) was found, and a trend towards less air leak. In the subgroup analysis of trials studying an unselected population of ventilated infants, no significant differences were found for any of the outcomes.
AUTHORS' CONCLUSIONS
For ventilated preterm infants with evidence of asynchronous respiratory efforts, neuromuscular paralysis with pancuronium seems to have a favourable effect on intraventricular hemorrhage and possibly on air leak. Uncertainty remains, however, regarding the long term pulmonary and neurologic effects, and regarding the safety of prolonged use of pancuronium in ventilated newborn infants. There is no evidence from randomized trials on the effects of neuromuscular blocking agents other than pancuronium. The routine use of pancuronium or any other neuromuscular blocking agent in ventilated newborn infants cannot be recommended based on current evidence.
Topics: Cerebral Hemorrhage; Humans; Infant, Newborn; Infant, Premature; Neuromuscular Blockade; Neuromuscular Nondepolarizing Agents; Outcome Assessment, Health Care; Pancuronium; Pneumothorax; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Distress Syndrome, Newborn
PubMed: 15846639
DOI: 10.1002/14651858.CD002773.pub2 -
Jornal de Pediatria Mar 2005To describe the main controversies about resuscitation procedures performed in extremely low birth weight infants in the delivery room. (Review)
Review
OBJECTIVE
To describe the main controversies about resuscitation procedures performed in extremely low birth weight infants in the delivery room.
SOURCES OF DATA
Systematic review including articles from MEDLINE, SciELO and Cochrane Library, and abstracts published in national and international proceedings, using the keywords resuscitation, asphyxia, and newborn infant.
SUMMARY OF THE FINDINGS
The main controversies concern the oxygenation and ventilation of extremely low birth weight infants. The effects of oxygen concentrations between 21 and 100% need to be addressed. Appropriate inspiratory pressure, lung volume, and positive end-expiratory pressure parameters also need to be established in order to decrease barotrauma and volutrauma. The benefits of nasal continuous positive airway pressure may be determined through randomized clinical trials. On top of that, manual resuscitation devices have to be developed in order to optimize these ventilatory parameters and to reduce lung injury. So far, clinical trials on the administration of epinephrine, volume expanders, and sodium bicarbonate to extremely low birth weight infants have not been published. In addition, the main ethical dilemma concerns the decision of health professionals and parents not to initiate resuscitation procedures at very low gestational ages.
CONCLUSIONS
In the future, guidelines may be modified based on the results of randomized and controlled clinical trials, as well as neurodevelopmental follow-up studies, involving extremely low birth weight infants submitted to resuscitation procedures in the delivery room.
Topics: Delivery Rooms; Humans; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Intubation, Intratracheal; Oxygen Inhalation Therapy; Pulmonary Ventilation; Resuscitation
PubMed: 15809695
DOI: 10.2223/1295