Estrada Jose, Armanious Irene, Perri Dan, Cook Deborah J, Duan Erick Huaileigh, Bosma Karen, Hassall Kelly, Marchildon Corry, Mehta Sangeeta, Jaeschke Roman, Piraino Thomas, Carayannopoulos Kallirroi Laiya, Alhazzani Waleed, Lewis Kimberley
The Research Institute of St Joe's Hamilton, Hamilton, Ontario, Canada.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2025 Jun 19;15(6):e096053. doi: 10.1136/bmjopen-2024-096053.
The cuff leak test (CLT) is hypothesised to help optimise extubation by assessing for laryngeal oedema which, if unrecognised and untreated, could lead to post-extubation stridor, post-extubation airway obstruction, and reintubation. However, the diagnostic accuracy of the CLT to detect post-extubation stridor (and hence potentially airway obstruction) remains uncertain. Given the equipoise that exists surrounding the CLT, we are conducting a pilot randomised clinical trial (RCT) examining the CLT as part of the pathway to extubation. Herein, we report the protocol for the uff Leak Test and Airway btruction in echanically Ventilated U Patients (COSMIC): a Pilot Feasibility Randomized Clinical trial (RCT).
This is a multicentre, international, parallel-group, pragmatic, pilot RCT. We will enrol 100 mechanically ventilated patients in the intensive care unit (ICU) who are deemed ready for extubation and have at least one risk factor for laryngeal oedema. In the intervention arm, respiratory therapists will perform a qualitative CLT before extubation. If a patient passes the CLT (suggesting no laryngeal oedema), extubation will be performed in keeping with standard care. If the patient fails the CLT (suggesting laryngeal oedema), extubation will be delayed allowing for administration of dexamethasone, consideration of diuresis, and the CLT will be repeated in 12-24 hours. In the control arm, patients will be extubated without completing a CLT, without steroid administration, and without delay. Randomization will be by a 1:1 allocation, stratified by centre. The primary feasibility outcomes will include recruitment and protocol adherence. Secondary outcomes will include post-extubation stridor, reintubation within 72 hours, emergency surgical airway within 72 hours, and ICU and hospital mortality within 30 days.
This trial has been approved by Clinical Trials Ontario, Hamilton Integrated Research Ethics Board, State of Kuwait Ministry of Health, University of Texas Health Committee for the Protection of Human Subjects and Brant Community Health Systems Research Ethics Committee. The trial has received a No Objection Letter from Health Canada. Trial results will be disseminated via publication in peer-reviewed journals.
NCT05456542.
袖带漏气试验（CLT）的假设是通过评估喉水肿来帮助优化拔管，若未识别和治疗喉水肿，可能导致拔管后喘鸣、拔管后气道梗阻和再次插管。然而，CLT检测拔管后喘鸣（进而可能检测气道梗阻）的诊断准确性仍不确定。鉴于围绕CLT存在的平衡状态，我们正在开展一项试点随机临床试验（RCT），将CLT作为拔管流程的一部分进行研究。在此，我们报告机械通气患者袖带漏气试验与气道梗阻（COSMIC）的方案：一项试点可行性随机临床试验（RCT）。
这是一项多中心、国际性、平行组、务实的试点RCT。我们将纳入100名重症监护病房（ICU）中被认为已准备好拔管且至少有一个喉水肿危险因素的机械通气患者。在干预组，呼吸治疗师将在拔管前进行定性CLT。如果患者通过CLT（提示无喉水肿），将按照标准护理进行拔管。如果患者未通过CLT（提示有喉水肿），拔管将延迟，以便给予地塞米松、考虑利尿，并在12 - 24小时后重复CLT。在对照组，患者将不进行CLT、不给予类固醇且不延迟地进行拔管。随机分组将按1:1分配，按中心分层。主要可行性结局将包括招募情况和方案依从性。次要结局将包括拔管后喘鸣、72小时内再次插管、72小时内紧急手术气道以及30天内的ICU和医院死亡率。
本试验已获得安大略省临床试验、汉密尔顿综合研究伦理委员会、科威特卫生部、德克萨斯大学人类受试者保护健康委员会以及布兰特社区卫生系统研究伦理委员会的批准。该试验已收到加拿大卫生部的无异议函。试验结果将通过在同行评审期刊上发表进行传播。
NCT05456542。
