-
World Journal of Surgery Nov 2019Pharyngolaryngeal symptoms are a main concern after neck surgery. The Protector™ LMA is a new supraglottic airway device. The main purpose of this study was to... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Pharyngolaryngeal symptoms are a main concern after neck surgery. The Protector™ LMA is a new supraglottic airway device. The main purpose of this study was to evaluate whether application of the LMA Protector™ causes fewer pharyngolaryngeal symptoms than application of the endotracheal tube after minimally invasive total thyroidectomy and parathyroidectomy.
METHODS
This prospective, randomized controlled trial involved one university and one private practice clinic, during the period from January 2017 until November 2017. The patients were randomly allocated to two groups: ETT and LMA. Main outcomes were Numerical Rating Scale scores of postoperative dysphagia, pharyngodynia, and incisional pain. Secondary outcomes were the frequency of rescue analgesia (paracetamol) consumption and emergence cough. Data were recorded in the post-anesthesia care unit and at 1, 6, 12, and 24 h after surgery.
RESULTS
Data from 78 patients were included in the final analysis. Pharyngodynia scores were significantly lower in the LMA group, compared with the ETT group, at 1 h, 6 h and 12 h after surgery. Dysphagia and surgical incision pain scores were also significantly lower in the LMA group, compared with the ETT group, at 6 h and 12 h after surgery. The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group. Finally, the LMA group had fewer episodes of emergence cough, compared with the ETT group.
CONCLUSION
The LMA Protector™ causes fewer pharyngolaryngeal symptoms than the ETT within 6 and 12 h after minimally invasive total thyroidectomy and parathyroidectomy.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT03098667.
Topics: Acetaminophen; Adult; Aged; Analgesics, Non-Narcotic; Cough; Deglutition Disorders; Female; Humans; Intubation, Intratracheal; Laryngeal Masks; Male; Middle Aged; Minimally Invasive Surgical Procedures; Pain, Postoperative; Parathyroidectomy; Postoperative Period; Prospective Studies; Single-Blind Method; Surgical Wound; Thyroid Gland; Thyroidectomy
PubMed: 31410514
DOI: 10.1007/s00268-019-05122-8 -
BMC Anesthesiology Jan 2019Insertion under laryngoscopic guidance has been used to achieve ideal positioning of the laryngeal mask airway (LMA). However, to date, the efficacy of this technique... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Insertion under laryngoscopic guidance has been used to achieve ideal positioning of the laryngeal mask airway (LMA). However, to date, the efficacy of this technique has been evaluated only using fiberoptic evaluation, and the results have been conflicting. Other reliable tests to evaluate the efficacy of this technique have not been established. Recently, it has been suggested that the accuracy of LMA placement can be determined by clinical signs such as oropharyngeal leak pressure (OPLP). The aim of this study was to assess the efficacy of LMA insertion under laryngoscopic guidance using OPLP as an indicator.
METHODS
After approved by the institutional ethics committee, a prospective comparison of 100 patients divided into 2 groups (50 with blind technique and 50 with the laryngoscope technique) were evaluated. An LMA (LarySeal™, Flexicare medical Ltd., UK) was inserted using the blind approach in the blind insertion group and using laryngoscopy in the laryngoscope-guided insertion group. The OPLP, fiberoptic position score, whether the first attempt at LMA insertion was successful, time taken for insertion, ease of LMA insertion, and adverse airway events were recorded.
RESULTS
Data were presented as mean ± standard deviation. The OPLP was higher in the laryngoscope-guided insertion group than in the blind insertion group (21.4 ± 8.6 cmHO vs. 18.1 ± 6.1 cmHO, p = 0.031). The fiberoptic position score, rate of success in the first attempt, ease of insertion, and pharyngolaryngeal adverse events were similar between both groups. The time taken for insertion of the LMA was significantly longer in the laryngoscope-guided insertion group, compared to blind insertion group (35.9 ± 9.5 s vs. 28.7 ± 9.5 s, p < 0.0001).
CONCLUSION
Laryngoscope-guided insertion of LMA improves the airway seal pressure compared to blind insertion. Our result suggests that it may be a useful technique for LMA insertion.
TRIAL REGISTRATION
cris.nih.go.kr , identifier: KCT0001945 (2016-06-17).
Topics: Aged; Female; Fiber Optic Technology; Humans; Intubation, Intratracheal; Laryngeal Masks; Laryngoscopes; Laryngoscopy; Male; Middle Aged; Prospective Studies
PubMed: 30611202
DOI: 10.1186/s12871-018-0674-6 -
Anaesthesia, Critical Care & Pain... Aug 2019The optimal size of the I-Gel remains unclear since the manufacturer's weight-based formula (size 3 for weight < 50 kg, size 4 for weight 50-90 kg, and size 5... (Comparative Study)
Comparative Study
PURPOSE
The optimal size of the I-Gel remains unclear since the manufacturer's weight-based formula (size 3 for weight < 50 kg, size 4 for weight 50-90 kg, and size 5 for weight > 90 kg) for the laryngeal mask airway I-Gel is not evidence-based. We hypothesised that sex may also guide the choice of I-Gel size.
METHODS
Insertion success rates of the I-Gel chosen according to the weight-based formula were prospectively recorded and compared with those of a patients' cohort ventilated with an I-Gel chosen according to the sex-based formula recorded. Two periods of 18 months were randomised in three independent hospitals in France to study each choice strategy. Patients requiring I-Gel size change were compared with those who where successfully ventilated with the initially chosen device. Complications linked to the I-Gel and factors for changing the size of the I-Gel were also recorded and analysed.
RESULTS
Data from 900 patients were prospectively collected in the three participating centres. The overall initial ventilation was inadequate in 80 cases, including 7% (n = 31) in the weight-based group and 3% (n = 13) in the sex-based group (P = 0.01). In the weight-based group, changing size of I-Gel was successful in 28 (90%) cases. In the sex-based group, changing size of I-Gel was useful in 1 case only. Endotracheal tube insertion was necessary in 15 cases despite changing I-Gel size, including 3 cases in the weight-based group and 12 cases in the sex-based group. Ease of insertion and postoperative pharyngo-laryngeal problems were similar between groups with or without changing size of I-Gel.
CONCLUSION
Adequate ventilation is achieved most of the time using size selection for the I-Gel laryngeal mask airway according to the manufacturer's weight-based formula. However, our results suggest that the sex-based formula in healthy, anaesthetised, adult patients may also be appropriate for I-Gel size choice.
Topics: Adult; Aged; Body Weight; Equipment Design; Female; Humans; Laryngeal Masks; Male; Middle Aged; Prospective Studies; Respiration
PubMed: 30336273
DOI: 10.1016/j.accpm.2018.08.003 -
Anesthesia and Analgesia Feb 2020Age-related changes in upper airway anatomy may affect the overall performance of supraglottic airways significantly. The clinical performance of the i-gel and the... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Age-related changes in upper airway anatomy may affect the overall performance of supraglottic airways significantly. The clinical performance of the i-gel and the self-pressurized air-Q intubating laryngeal airways with noninflatable cuffs for elderly populations remains unknown, unlike in children. Thus, we performed a prospective, randomized comparison of these 2 supraglottic airways in elderly patients undergoing general anesthesia.
METHODS
We recruited 100 patients, 65-90 years of age, who were scheduled for elective surgery under general anesthesia with muscle relaxation. The enrolled patients were allocated to the i-gel or self-pressurized air-Q group. We assessed oropharyngeal leak pressure as the primary outcome and fiberoptic view after placement and fixation of the airway and at 10 minutes after the initial assessment. The fiberoptic view was scored using a 5-point scale as follows: vocal cords not visible; vocal cords and anterior epiglottis visible, >50% visual obstruction of epiglottis to vocal cords; vocal cords and anterior epiglottis visible, <50% visual obstruction of epiglottis to vocal cords; vocal cords and posterior epiglottis visible; and vocal cords visible. We also investigated success rate and ease of insertion, insertion time, and manipulations during insertion as insertion variables, complications during maintenance and emergence periods, and postoperative pharyngolaryngeal complications including sore throat, dysphagia, and dysphonia.
RESULTS
After assessing for eligibility, 48 patients were allocated to each group. Oropharyngeal leak pressures were significantly higher in the i-gel group than in the self-pressurized air-Q group (P < .001) at the 2 measurement points. The raw mean difference at initial assessment and the median difference after 10 minutes were 5.5 cm H2O (95% confidence interval, 3.3-7.6 cm H2O) and 5.0 (95% confidence interval, 2.0-7.0 cm H2O), respectively. The initial scores of fiberoptic view were similar in the 2 groups. However, the self-pressurized air-Q supraglottic airway provided a significantly improved fiberoptic view at 10 minutes after initial assessment (P = .030). We found no statistically significant differences in insertion variables and complications between the 2 groups.
CONCLUSIONS
The i-gel provided better sealing function than the self-pressurized air-Q supraglottic airway according to the high oropharyngeal leak pressures in elderly patients during general anesthesia. The self-pressurized air-Q supraglottic airway had improved fiberoptic views in elderly patients during general anesthesia.
Topics: Aged; Aged, 80 and over; Airway Management; Anesthesia, General; Female; Humans; Intubation, Intratracheal; Laryngeal Masks; Male; Prospective Studies
PubMed: 30320644
DOI: 10.1213/ANE.0000000000003849 -
Journal of Vascular and Interventional... Jun 2018To evaluate the efficacy and safety of sclerotherapy with sodium tetradecyl sulfate (STS) and bleomycin for treatment of venous malformations (VMs) of the oropharyngeal...
PURPOSE
To evaluate the efficacy and safety of sclerotherapy with sodium tetradecyl sulfate (STS) and bleomycin for treatment of venous malformations (VMs) of the oropharyngeal region.
MATERIALS AND METHODS
A retrospective study of 33 patients with 46 VMs of the buccal and pharyngolaryngeal cavity associated with impairment of eating, respiration, or elocution was performed. Individual lesions were divided based on their anterior or posterior location, using the base of the tongue as an anatomic landmark. Lesion size was estimated with the use of orthogonal measurements on magnetic resonance or ultrasound images before and after treatment to assess radiologic response. Sclerotherapy sessions were performed under ultrasound, fluoroscopic, and, if needed, endoscopic guidance. Clinical response was assessed with the use of the Manchester Orofacial Pain Disability Scale. Methods for airway management were also compiled.
RESULTS
Following sclerotherapy, average VM diameter was reduced by 31.4% (P < .0001) on a per-patient basis and by 30.8% (P < .0001) on a per-lesion basis. The Manchester score improved by an average of 37.0% (P = .013). Four patients reported a worsening of symptoms, and 11 patients experienced symptomatic recurrence. Complications include pneumonia (5 patients) and urgent placement of a post-procedure tracheostomy (4 patients). Patients with posterior malformations experienced more complications (emergency tracheostomies in 4 and pneumonias in 4).
CONCLUSIONS
Sclerotherapy using STS is an efficient treatment for venous malformations of the buccal and pharyngolaryngeal cavity but can lead to significant complication for posterior lesions. Careful assessment of the airway is needed before treatment, and prophylactic tracheotomy should be considered in patients with posterior lesions.
Topics: Adolescent; Adult; Aged; Bleomycin; Female; Humans; Male; Middle Aged; Oropharynx; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Treatment Outcome; Vascular Malformations
PubMed: 29628299
DOI: 10.1016/j.jvir.2017.12.028 -
The Cochrane Database of Systematic... Feb 2018Several agents are used to clear secretions from the airways of people with cystic fibrosis. Mannitol increases mucociliary clearance, but its exact mechanism of action... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several agents are used to clear secretions from the airways of people with cystic fibrosis. Mannitol increases mucociliary clearance, but its exact mechanism of action is unknown. The dry powder formulation of mannitol may be more convenient and easier to use compared with established agents which require delivery via a nebuliser. Phase III trials of inhaled dry powder mannitol for the treatment of cystic fibrosis have been completed and it is now available in Australia and some countries in Europe. This is an update of a previous review.
OBJECTIVES
To assess whether inhaled dry powder mannitol is well tolerated, whether it improves the quality of life and respiratory function in people with cystic fibrosis and which adverse events are associated with the treatment.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic databases, handsearching relevant journals and abstracts from conferences.Date of last search: 28 September 2017.
SELECTION CRITERIA
All randomised controlled studies comparing mannitol with placebo, active inhaled comparators (for example, hypertonic saline or dornase alfa) or with no treatment.
DATA COLLECTION AND ANALYSIS
Authors independently assessed studies for inclusion, carried out data extraction and assessed the risk of bias in included studies. The quality of the evidence was assessed using GRADE.
MAIN RESULTS
Six studies (reported in 50 publications) were included with a total of 784 participants.Duration of treatment in the included studies ranged from 12 days to six months, with open-label treatment for an additional six months in two of the studies. Five studies compared mannitol with control (a very low dose of mannitol or non-respirable mannitol) and the final study compared mannitol to dornase alfa alone and to mannitol plus dornase alfa. Two large studies had a similar parallel design and provided data for 600 participants, which could be pooled where data for a particular outcome and time point were available. The remaining studies had much smaller sample sizes (ranging from 22 to 95) and data could not be pooled due to differences in design, interventions and population.Pooled evidence from the two large parallel studies was judged to be of low to moderate quality and from the smaller studies was judged to be of low to very low quality. In all studies, there was an initial test to see if participants tolerated mannitol, with only those who could tolerate the drug being randomised; therefore, the study results are not applicable to the cystic fibrosis population as a whole.While the published papers did not provide all the data required for our analysis, additional unpublished data were provided by the drug's manufacturer and the author of one of the studies.Pooling the large parallel studies comparing mannitol to control, up to and including six months, lung function (forced expiratory volume at one second) measured in both mL and % predicted was significantly improved in the mannitol group compared to the control group (moderate-quality evidence). Beneficial results were observed in these studies in adults and in both concomitant dornase alfa users and non-users in these studies. In the smaller studies, statistically significant improvements in lung function were also observed in the mannitol groups compared to the non-respirable mannitol groups; however, we judged this evidence to be of low to very low quality.For the comparisons of mannitol and control, we found no consistent differences in health-related quality of life in any of the domains except for burden of treatment, which was less for mannitol up to four months in the two pooled studies of a similar design; this difference was not maintained at six months. It should be noted that the tool used to measure health-related quality of life was not designed to assess mucolytics and pooling of the age-appropriate tools (as done in some of the included studies) may not be valid so results were judged to be low to very low quality and should be interpreted with caution. Cough, haemoptysis, bronchospasm, pharyngolaryngeal pain and post-tussive vomiting were the most commonly reported side effects in both treatment groups. Where rates of adverse events could be compared, statistically no significant differences were found between mannitol and control groups; although some of these events may have clinical relevance for people with CF.For the comparisons of mannitol to dornase alfa alone and to mannitol plus dornase alfa, very low-quality evidence from a 12-week cross-over study of 28 participants showed no statistically significant differences in the recorded domains of health-related quality of life or measures of lung function. Cough was the most common side effect in the mannitol alone arm but there was no occurrence of cough in the dornase alfa alone arm and the most commonly reported reason of withdrawal from the mannitol plus dornase alfa arm was pulmonary exacerbations.In terms of secondary outcomes of the review (pulmonary exacerbations, hospitalisations, symptoms, sputum microbiology), evidence provided by the included studies was more limited. For all comparisons, no consistent statistically significant and clinically meaningful differences were observed between mannitol and control treatments (including dornase alfa).
AUTHORS' CONCLUSIONS
There is moderate-quality evidence to show that treatment with mannitol over a six-month period is associated with an improvement in some measures of lung function in people with cystic fibrosis compared to control. There is low to very low-quality evidence suggesting no difference in quality of life for participants taking mannitol compared to control. This review provides very low-quality evidence suggesting no difference in lung function or quality of life comparing mannitol to dornase alfa alone and to mannitol plus dornase alfa.The clinical implications from this review suggest that mannitol could be considered as a treatment in cystic fibrosis; but further research is required in order to establish who may benefit most and whether this benefit is sustained in the longer term. Furthermore, studies comparing its efficacy against other (established) mucolytic therapies need to be undertaken before it can be considered for mainstream practice.
Topics: Administration, Inhalation; Adult; Child; Cystic Fibrosis; Deoxyribonuclease I; Humans; Mannitol; Mucociliary Clearance; Powders; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Function Tests
PubMed: 29424930
DOI: 10.1002/14651858.CD008649.pub3 -
Clinical Therapeutics Sep 2017The tree pollen sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) is being developed for the treatment of tree pollen induced allergic rhinitis with or without... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
The tree pollen sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) is being developed for the treatment of tree pollen induced allergic rhinitis with or without conjunctivitis. The objective of this Phase I trial was to investigate the tolerability and acceptable dose range of the SQ tree SLIT-tablet in adults with allergic rhinoconjunctivitis.
METHODS
The trial was a randomized, double-blind, placebo-controlled, dose escalation Phase I trial that included 70 adults (aged 19-61 years) with birch pollen-induced rhinoconjunctivitis with or without mild to moderate asthma. The trial included 6 different dosage groups that were randomized 3:1 to active treatment or placebo once daily for 28 days. Adverse events (AEs) were coded in the Medical Dictionary for Regulatory Activities by medically qualified personnel. Immunologic assessments included IgE and IgE-blocking factor.
FINDINGS
Most (96%) reported AEs were mild, and only 5 severe events (0.2%) were reported. The most frequently reported investigational medicinal product-related AEs were oral pruritus, ear pruritus, mouth edema, sensation of foreign body, throat irritation, pharyngolaryngeal pain, dry throat, tongue blistering, eye pruritus, and headache. The trial included doses ranging from 1 to 24 development units (DU), and the mean number of investigational medicinal product-related AEs per participant was highest in the 24 DU group. The 12 and 24 DU doses induced statistically significant changes from baseline compared with placebo in birch specific IgE and IgE-blocking factor.
IMPLICATIONS
The trial found that doses up to 12 DU of the SQ tree SLIT tablet have a tolerability profile suitable for at-home administration. An immunomodulatory effect was found for all doses included in the trial, and doses up to 12 DU were thus chosen for further clinical development of the SQ tree SLIT tablet. EudraCT identifier: 2007-003234-42.
Topics: Administration, Sublingual; Adult; Allergens; Antigens, Neoplasm; Asthma; Conjunctivitis, Allergic; Denmark; Double-Blind Method; Female; Humans; Immunoglobulin E; Male; Middle Aged; Pollen; Rhinitis, Allergic, Seasonal; Sublingual Immunotherapy; Tablets; Trees; Young Adult
PubMed: 28844318
DOI: 10.1016/j.clinthera.2017.08.003 -
Ear, Nose, & Throat Journal Mar 2017Pemphigus vulgaris is an autoimmune blistering disorder that involves the skin and mucous membranes. Few reports have described nasal and oropharyngolaryngeal lesions in...
Pemphigus vulgaris is an autoimmune blistering disorder that involves the skin and mucous membranes. Few reports have described nasal and oropharyngolaryngeal lesions in pemphigus vulgaris using an endoscopic ororhinolaryngologic examination. We retrospectively reviewed the clinical records of 11 patients with pemphigus vulgaris between 2001 and 2013 with respect to their symptoms, lesion sites, lesion features, and treatments received. All patients had undergone an endoscopic ororhinolaryngologic examination. Their mucosa-related symptoms were sore throat, oral pain, odynophagia, gingival bleeding, hoarseness, and epistaxis. The most frequent sites were the oral cavity (gingiva and buccal mucosa), larynx (epiglottis and vocal fold), oropharynx (soft palate), and nasal cavity (nasal septum). Lesions were typically characterized by erosion, erosion with a whitish exudate, and erythematous patches. Thus, our study findings reveal that pemphigus vulgaris involves both the nasal and oropharyngolaryngeal regions. Patients with pemphigus vulgaris should undergo an endoscopic ororhinolaryngologic examination to determine the range of their lesions.
Topics: Adult; Aged; Aged, 80 and over; Female; Gingiva; Humans; Laryngoscopy; Larynx; Male; Middle Aged; Mouth Mucosa; Nasal Cavity; Oropharynx; Otorhinolaryngologic Surgical Procedures; Pemphigus; Retrospective Studies
PubMed: 28346642
DOI: 10.1177/014556131709600311 -
Clinics and Practice Jan 2017Most patients complaining of pharyngeal pain have an upper respiratory tract infection or other local explanation for their pain. Here we show 3 rare cases of patients...
Most patients complaining of pharyngeal pain have an upper respiratory tract infection or other local explanation for their pain. Here we show 3 rare cases of patients visiting our Otorhinolaryngology Department who had an initial symptom of pharyngeal pain caused by acute coronary syndrome (ACS). An electrocardiogram and a cardiac biomarker test are recommended to exclude ACS with atypical presentation in cases without pharyngolaryngeal findings comparable to pharyngeal pain.
PubMed: 28243429
DOI: 10.4081/cp.2017.904 -
Korean Journal of Anesthesiology Dec 2016Anterior cervical osteophytes are commonly found in elderly patients, but rarely produce symptoms. When symptoms occur, they can range from mild symptoms of dysphagia,...
Anterior cervical osteophytes are commonly found in elderly patients, but rarely produce symptoms. When symptoms occur, they can range from mild symptoms of dysphagia, dysphonia, and foreign body sensation to severe symptoms of airway obstruction due to compression of the pharynx or larynx. We report the case of a 59-year-old man who underwent brain tumor surgery, and developed post-operative respiratory difficulty due to progressive pharyngo-laryngeal edema, requiring urgent endotracheal intubation, secondary to the presence of a previously asymptomatic anterior cervical osteophyte. It is paramount to recognize that asymptomatic anterior cervical osteophytes are a potential cause of life-threatening post-operative respiratory complications that can rapidly progress to life-threatening airway obstruction after surgeries in the prone position, especially in elderly patients.
PubMed: 27924209
DOI: 10.4097/kjae.2016.69.6.640