Faculty Opinions recommendation of The effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverse events in infants: a randomised controlled trial.

BackgroundCarrageenan, a non-toxic gelling agent derived from red algae, has potent anti-human papillomavirus (HPV) activity in in vitro and animal studies. We assessed, in an interim analysis, the efficacy of a carrageenan-based gel in reducing the risk of new detections of anal HPV among gay, bisexual and other men who have sex with men (gbMSM).MethodsThe LIMIT-HPV study (Lubricant Investigation in Men to Inhibit Transmission of HPV Infection) is a phase IIb, double-blind, placebo-controlled randomised controlled trial conducted in Montreal, Canada. gbMSM were randomly assigned (1:1) to receive a carrageenan-based or placebo gel. Participants were instructed to apply the gel to the anus, condom and/or partners’ penis before and—as required—during receptive anal intercourse. Questionnaire data and anal samples were collected at 0, 1, 2, 3, 6, 9 and 12 months. We estimated new detections of anal HPV infection(s) detected via Linear Array using Cox proportional hazards models.ResultsParticipants recruited from February 2016 to December 2019 were randomly assigned to the carrageenan (n=127) or placebo (n=128) arm. The efficacy and safety analyses included 201 and 210 participants. The median follow-up time was 7.6 months (range: 0–28.5) in the carrageenan group and 9.3 months (range: 0–40.7) in the placebo group. The HR for new detections was 1.21 (95% CI 0.86 to 1.70): 69.4% and 65.1% new detections of HPV in the carrageenan and placebo arms, respectively. More adverse events were reported in the carrageenan (59.8%) compared with the placebo (39.8%) arm.ConclusionsThe interim analysis did not demonstrate a protective effect of carrageenan on the risk of new detections of anal HPV infection among gbMSM. Carrageenan gel use was associated with a higher proportion of adverse events. Given these findings and the (assumed) low probability that a beneficial effect would be found by the study’s end, the trial was terminated as recommended by the Data Safety and Monitoring Board.Trial registration numberNCT02354144.

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A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement

European Respiratory Journal ◽

10.1183/13993003.01753-2021 ◽

2021 ◽

pp. 2101753

Author(s):

Rachel M Mercer ◽

Eleanor Mishra ◽

Radhika Banka ◽

John P Corcoran ◽

Cyrus Daneshvar ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Adverse Events ◽

Standard Care ◽

Primary Outcome ◽

Controlled Trial ◽

Clinical Problem ◽

Outcome Data ◽

Chest Drain ◽

Drain Removal ◽

Randomised Controlled

BackgroundChest drain displacement is a common clinical problem, occurring in 9–42% of cases and results in treatment failure or additional pleural procedures conferring unnecessary risk. A novel chest drain with an integrated intrapleural balloon may reduce the risk of displacement.MethodsProspective randomised controlled trial comparing the balloon drain to standard care (12 F chest drain with no balloon) with the primary outcome of objectively-defined unintentional or accidental chest drain displacement.Results267 patients were randomised (primary outcome data available in 257, 96.2%). Displacement occurred less frequently using the balloon drain (displacement 5/128, 3.9%; standard care displacement 13/129, 10.1%) but this was not statistically significant (Odds Ratio (OR) for drain displacement 0.36, 95% CI 0.13 to 1.0, χ2 1df=2.87, p=0.09). Adjusted analysis to account for minimisation factors and use of drain sutures demonstrated balloon drains were independently associated with reduced drain fall out rate (adjusted OR 0.27, 95% CI 0.08 to 0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59/131, 45.0%; standard care 18/132, 13.6%; χ2 1df=31.3, p<0.0001).ConclusionBalloon drains reduce displacement compared with standard drains independent of the use of sutures but are associated with increased adverse events specifically during drain removal. The potential benefits of the novel drain should be weighed against the risks, but may be considered in practices where sutures are not routinely used.

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The skill of tracheal intubation with rigid scopes – a randomised controlled trial comparing learning curves in 740 intubations

BMC Anesthesiology ◽

10.1186/s12871-020-01181-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lorenz Theiler ◽

Robert Greif ◽

Lukas Bütikofer ◽

Kristopher Arheart ◽

Maren Kleine-Brueggeney

Keyword(s):

Randomised Controlled Trial ◽

Adverse Events ◽

Confidence Interval ◽

Learning Effect ◽

Controlled Trial ◽

Geometric Mean ◽

Success Probability ◽

Learning Curves ◽

Secondary Outcome ◽

Randomised Controlled

Abstract Background Rigid scopes are successfully used for management of difficult airways, but learning curves have not been established. Methods This randomised controlled trial was performed at the University Hospital Bern in Switzerland to establish learning curves for the rigid scopes Bonfils and SensaScope and to assess their performance. Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia. According to randomisation, physicians intubated the patient’s trachea with either the Bonfils or the SensaScope. A maximum of three intubation attempts was allowed. Primary outcome was overall time to successful intubation. Secondary outcome parameters included first attempt success, first attempt success within 60 s, failures and adverse events. Results A clear learning effect was demonstrated: Over 20 trials, intubations became 2.5-times quicker and first attempt intubation success probability increased by 21–28 percentage points. Fourteen and 20 trials were needed with the Bonfils and the SensaScope, respectively, to reach a 90% first attempt success probability. Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12–1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45–0.92, p = 0.016) with the SensaScope. Consultants showed a tendency for a better first attempt success compared to registrars. Overall, 23 intubations (10 Bonfils, 13 SensaScope) failed. Adverse events were rare and did not differ between devices. Conclusions A clear learning effect was demonstrated for both rigid scopes. Fourteen intubations with the Bonfils and 20 intubations with the SensaScope were required to reach a 90% first attempt success probability. Learning of the technique seemed more complex with the SensaScope compared to the Bonfils. Trial registration Current Controlled Trials, ISRCTN14429285. Registered 28 September 2011, retrospectively registered.

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Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID): a randomised controlled trial in systemic cancer treatment

BMC Cancer ◽

10.1186/s12885-017-3303-8 ◽

2017 ◽

Vol 17 (1) ◽

Cited By ~ 26

Author(s):

Kate Absolom ◽

◽

Patricia Holch ◽

Lorraine Warrington ◽

Faye Samy ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Adverse Events ◽

Cancer Treatment ◽

Patient Information ◽

Controlled Trial ◽

Randomised Controlled

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A Randomised Controlled Trial Comparing Fibreoptic-Guided Tracheal Intubation through Two Supraglottic Devices: Ambu® Auragain™ Laryngeal Mask and LMA® Fastrach™

Anaesthesia and Intensive Care ◽

10.1177/0310057x1804600508 ◽

2018 ◽

Vol 46 (5) ◽

pp. 474-479 ◽

Cited By ~ 4

Author(s):

G. Preece ◽

I. Ng ◽

K. Lee ◽

P. Mezzavia ◽

R. Krieser ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Endotracheal Intubation ◽

Controlled Trial ◽

Muscle Relaxation ◽

Laryngeal Mask ◽

Supraglottic Airway ◽

Supraglottic Airway Devices ◽

Airway Pathology ◽

Airway Devices ◽

Randomised Controlled

The Ambu®AuraGain™ laryngeal mask (LM) (Ambu A/S, Ballerup, Denmark) is one of the few readily available second-generation supraglottic airway devices (SADs) that offer a conduit for fibreoptic-guided endotracheal intubation. We aimed to compare fibreoptic intubation through this device with the LMA® (laryngeal mask airway) Fastrach™ (Teleflex Medical, Co. Westmeath, Ireland), which has been a recommended dedicated rescue device for the management of the unanticipated difficult airway. This randomised controlled trial compared a previously described fibreoptic score in 116 patients with no known airway pathology, who had asleep fibreoptic endotracheal intubation via either the AuraGain LM or the LMA Fastrach. Time, ease and success rate of SAD and endotracheal tube (ETT) insertion and complications were recorded. The AuraGain LM demonstrated better laryngeal alignment with 29 out of 59 patients in the AuraGain LM (AG) group having a Grade 4 view (only vocal cords visible), compared to 20 out of 54 patients in the LMA Fastrach (FT) group (P=0.003). It allowed significantly quicker and easier ETT intubation when used as a conduit. The AuraGain LM was also quicker to insert compared to the Fastrach LMA. Similar rates of minor complications, such as sore throat and dysphonia occurred in both groups. Our study indicates that when used in patients with complete muscle relaxation and no known airway pathology, the AuraGain LM achieves better laryngeal alignment and quicker, easier and more successful fibreoptic-guided ETT intubation than the Fastrach LMA.

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