Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
The Research Institute of St. Joseph's Healthcare Hamilton, St Joseph's Healthcare, Hamilton, Ontario, Canada.
BMJ Open. 2019 Jul 19;9(7):e029394. doi: 10.1136/bmjopen-2019-029394.
Endotracheal intubation and invasive mechanical ventilation are lifesaving interventions that are commonly performed in the intensive care unit (ICU). Laryngeal oedema is a known complication of intubation that may cause airway obstruction in a patient on extubation. To date, the only test available to predict this complication is the cuff leak test (CLT); however, its diagnostic accuracy and utility remains uncertain. Herein, we report the protocol for the CuffLeak and AirwayObstruction in MechanicallyVentilated ICU Patients (COMIC) pilottrial.
This will be a multicentred, pragmatic, pilot randomised controlled trial (RCT). We will enrol 100 mechanically ventilated patients in the ICU who are deemed ready for extubation. We will exclude patients at a high risk of laryngeal oedema. All enrolled patients will have a CLT done before extubation. In the intervention arm, the results of the CLT will be communicated to the bedside physician, and decision to extubate will be left to the treating team. In the control arm, respiratory therapist will not communicate the results of the CLT to the treating physician, and the patient will be extubated regardless of the CLT result. Randomisation will be done in a 1:1 allocation ratio, stratified by size of the endotracheal tube and duration of invasive mechanical ventilation.Although we will examine all clinical outcomes relevant for the future COMIC RCT, the primary outcomes of the COMIC pilottrial will be feasibility outcomes including: consent rate, recruitment rate and protocol adherence. Clinical outcomes include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation and ICU length of stay in days.
The Hamilton Integrated Research Ethics Board, Imam Abdulrahman Bin Faisal University Institutional Review Board and Bioethical Commission of the Jagiellonian University approved this study. The trial results will be disseminated via publication in peer-reviewed journals.
NCT03372707.
气管插管和有创机械通气是在重症监护病房（ICU）中进行的挽救生命的干预措施。喉水肿是插管的已知并发症，可导致拔管患者气道阻塞。迄今为止，唯一可用于预测此并发症的测试是气囊漏气测试（CLT）；然而，其诊断准确性和实用性仍不确定。在此，我们报告了机械通气 ICU 患者的 CuffLeak 和气道阻塞（COMIC）试验的方案。
这将是一项多中心、实用的、先导性随机对照试验（RCT）。我们将招募 100 名在 ICU 中被认为准备拔管的机械通气患者。我们将排除有发生喉水肿高风险的患者。所有入组患者在拔管前均进行 CLT。在干预组中，CLT 的结果将传达给床边医生，拔管决定将由治疗团队做出。在对照组中，呼吸治疗师不会将 CLT 的结果传达给主治医生，无论 CLT 结果如何，患者都将被拔管。随机化将按 1:1 分配比例进行，按气管内导管的大小和有创机械通气的持续时间分层。虽然我们将检查与未来 COMIC RCT 相关的所有临床结局，但 COMIC 先导试验的主要结局将是可行性结局，包括：同意率、招募率和方案依从性。临床结局包括拔管后喘鸣、再次插管、紧急手术气道、ICU 死亡率、院内死亡率、机械通气时间和 ICU 住院天数。
哈密尔顿综合研究伦理委员会、伊玛目阿卜杜勒拉赫曼·本·法伊萨尔大学机构审查委员会和雅盖隆大学生物伦理委员会批准了这项研究。试验结果将通过在同行评议期刊上发表来传播。
NCT03372707。
