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危重症患者经鼻高流量氧疗预充氧用于气管插管:一项随机临床试验。

Nasal high-flow preoxygenation for endotracheal intubation in the critically ill patient: a randomized clinical trial.

机构信息

Service de Réanimation Médico Chirurgicale, USC, Centre Hospitalier du Mans, 194 Avenue Rubillard, 72037, Le Mans Cedex 9, France.

Médecine Intensive Réanimation, INSERM CIC 1415, Centre Hospitalier Universitaire de Tours, Centre d'Etude des Pathologies Respiratoires INSERM U1100, Tours University, Tours, France.

出版信息

Intensive Care Med. 2019 Apr;45(4):447-458. doi: 10.1007/s00134-019-05529-w. Epub 2019 Jan 21.

Abstract

PURPOSE

Preoxygenation with high-flow therapy by nasal cannulae (HFNC) is now widespread in the intensive care unit (ICU). However, no large randomized study has assessed its relevance in non-severely hypoxemic patients. In a randomized controlled trial (PROTRACH study), we aimed to evaluate preoxygenation with HFNC vs. standard bag-valve mask oxygenation (SMO) in non-severely hypoxemic patients during rapid sequence intubation (RSI) in the ICU.

METHODS

Randomized controlled trial including non-severely hypoxemic patients requiring intubation in the ICU. Patients received preoxygenation by HFNC or SMO during RSI. HFNC was maintained throughout the intubation procedure whereas SMO was removed to perform laryngoscopy. The primary outcome was the lowest pulse oximetry (SpO) throughout the intubation procedure. Secondary outcomes included drop in SpO, adverse events related to intubation, and outcome in the ICU.

RESULTS

A total of 192 patients were randomized. In the intent-to-treat analysis, 184 patients (HFNC n = 95; SMO n = 89), the median [IQR] lowest SpO was 100% [97; 100] for HFNC and 99% [95; 100] for the SMO group (P = 0.30). Mild desaturation below 95% was more frequent with SMO (23%) than with HFNC (12%) (RR 0.51, 95% CI 0.26-0.99, P = 0.045). There were fewer adverse events in the HFNC group (6%) than in the SMO group (19%) (RR 0.31, 95% CI 0.13-0.76, P = 0.007), including fewer severe adverse events, respectively 6 (6%) and 14 (16%) with HFNC and SMO (RR 0.38, 95% CI 0.15-0.95, P = 0.03).

CONCLUSIONS

Compared with SMO, preoxygenation with HFNC in the ICU did not improve the lowest SpO during intubation in the non-severely hypoxemic patients but led to a reduction in intubation-related adverse events.

TRIAL REGISTRATION

Clinical trial Submission: 7 March 2016. Registry name: Benefits of high-flow nasal cannulae oxygen for preoxygenation during intubation in non-severely hypoxemic patients: the PROTRACH study. Clinicaltrials.gov identifier: NCT02700321. Eudra CT: 2015-A00145-44. CPP: 15/13-975 (Comité de protection des personnes de Rennes). URL registry: https://clinicaltrials.gov/ct2/show/record/NCT02700321 .

摘要

目的

经鼻高流量氧疗(HFNC)在重症监护病房(ICU)中已广泛应用于预充氧。然而,尚无大型随机研究评估其在非严重低氧血症患者中的相关性。在一项随机对照试验(PROTRACH 研究)中,我们旨在评估 HFNC 与标准球囊面罩通气(SMO)在 ICU 中需要快速序贯插管(RSI)的非严重低氧血症患者中的预充氧效果。

方法

这是一项纳入非严重低氧血症需要在 ICU 插管的患者的随机对照试验。患者在 RSI 期间接受 HFNC 或 SMO 预充氧。HFNC 在整个插管过程中持续使用,而 SMO 在进行喉镜检查时被移除。主要结局是整个插管过程中最低脉搏血氧饱和度(SpO)。次要结局包括 SpO 下降、与插管相关的不良事件以及 ICU 结局。

结果

共纳入 192 例患者。在意向治疗分析中,HFNC 组 95 例,SMO 组 89 例,184 例患者(HFNC 组 184 例;SMO 组 184 例)。HFNC 组的最低 SpO 中位数[IQR]为 100%[97;100],SMO 组为 99%[95;100](P=0.30)。SMO 组的轻度低氧血症(<95%)发生率高于 HFNC 组(23%比 12%)(RR 0.51,95%CI 0.26-0.99,P=0.045)。HFNC 组的不良事件发生率(6%)低于 SMO 组(19%)(RR 0.31,95%CI 0.13-0.76,P=0.007),包括更严重的不良事件,HFNC 组分别为 6 例(6%)和 SMO 组为 14 例(16%)(RR 0.38,95%CI 0.15-0.95,P=0.03)。

结论

与 SMO 相比,HFNC 预充氧并未改善非严重低氧血症患者插管期间的最低 SpO,但减少了与插管相关的不良事件。

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