Service d'Anesthésie-Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, PAYS-DE-LA-LOIRE, France.
UPRES EA 3826, "Thérapeutiques Cliniques et Expérimentales des infections", IRS2 Nantes Biotech, Centre Hospitalier Universitaire de Nantes, Nantes, PAYS-DE-LA-LOIRE, France.
BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909.
Although preoxygenation and airway management respond to precise algorithms, difficult intubation (DI) remains a daily challenge in intensive care units and in the operating rooms because of its frequent complications, including hypoxaemia. To prevent desaturation during DI, high-flow oxygenation by nasal cannula (HFNC) could prove beneficial. Indeed, contrary to standard preoxygenation device, it can be held in place throughout the intubation trying to perform apnoeic oxygenation during DI. Hence, recent guidelines recommend HFNC during DI, but its relevance has never been evaluated in this setting in a large randomised study until now.
The PREOPTIDAM trial is a prospective, single-centre, randomised, controlled study in Nantes University Hospital. In anticipated DI, we hypothesised that HFNC can decrease the incidence of desaturation ≤94% or face mask ventilation from 16% to 4% compared with standard device. Using a two-sided t-test with a first species risk of 5% and 80% power, a total of 186 patients will be included. Using a computer-generated randomisation, with a 1:1 allocation ratio, patients will be randomised to HFNC or face mask preoxygenation. Randomisation will be stratified on intubation sequence: Rapid sequence intubation or awake fibreoptic intubation. The primary objective is to determine whether HFNC is more efficient than standard oxygenation techniques to prevent desaturation ≤94% or face mask ventilation during DI. Intent-to-treat and per-protocol analysis are planned for the primary outcome.
The study project has been approved by an independent ethics committee. Written informed consent will be obtained before study inclusion. Participant recruitment begins in September 2018. Results will be submitted to international peer-reviewed medical journals.
NCT03604120.
尽管预充氧和气道管理可遵循精确的算法，但由于其常见并发症（包括低氧血症），在重症监护病房和手术室中，困难插管（DI）仍然是每天面临的挑战。为了防止 DI 期间发生低氧血症，可以通过鼻导管（HFNC）进行高流量氧合。实际上，与标准预充氧设备不同，HFNC 可以在整个插管过程中保持在位，试图在 DI 期间进行无通气氧合。因此，最近的指南建议在 DI 期间使用 HFNC，但直到现在，在一项大型随机研究中，尚未在这种情况下评估其相关性。
PREOPTIDAM 试验是在南特大学医院进行的一项前瞻性、单中心、随机、对照研究。在预期的 DI 中，我们假设 HFNC 可以将低氧血症（<94%）或面罩通气的发生率从 16%降低至 4%，与标准设备相比。使用双侧 t 检验，第一类风险为 5%，功效为 80%，共纳入 186 例患者。使用计算机生成的随机化，1:1 分配比例，将患者随机分为 HFNC 或面罩预充氧组。随机化将根据插管顺序分层：快速序贯插管或清醒纤维光学插管。主要目的是确定 HFNC 是否比标准氧合技术更有效，以防止 DI 期间低氧血症（<94%）或面罩通气。计划对主要结局进行意向治疗和方案分析。
研究项目已获得独立伦理委员会的批准。在研究纳入之前，将获得书面知情同意。参与者招募于 2018 年 9 月开始。结果将提交给国际同行评议的医学期刊。
NCT03604120。
