Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial,British Journal of Anaesthesia

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Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial
British Journal of Anaesthesia ( IF 9.8 ) Pub Date : 2022-01-05 , DOI: 10.1016/j.bja.2021.11.033
Stanislas Abrard ₁ , Emmanuel Rineau ₂ , Valerie Seegers ₃ , Nathalie Lebrec ₄ , Cyril Sargentini ₅ , Audrey Jeanneteau ₅ , Emmanuelle Longeau ₅ , Sigrid Caron ₆ , Jean-Christophe Callahan ₇ , Nicolas Chudeau ₇ , François Beloncle ₈ , Sigismond Lasocki ₅ , Denis Dupoiron ₄

Affiliation

Background

Pulmonary complications are an important cause of morbidity and mortality after surgery. We evaluated the clinical effectiveness of noninvasive ventilation (NIV) in preventing postoperative acute respiratory failure.

Methods

This is an open, multicentre randomised trial that included patients at high risk of postoperative pulmonary complications after elective or semi-urgent surgery with an Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score ≥45. Patients were randomly assigned to intermittent prophylactic face-mask NIV for 6–8 h day⁻¹ or usual postoperative care. The primary outcome was in-hospital acute respiratory failure within 7 days after surgery. Patients who underwent surgery and postoperative extubation were included in the modified intended-to-treat analysis. Results are presented as n (%) and odds ratios (ORs) with 95% confidence intervals.

Results

Between November 2017 and October 2019, 266 patients were randomised and 253 included in the main analysis. Of these, 203 (80.2%) were male with a mean age of 68 (11) yr and an ARISCAT score of 53 (6); 237 subjects (93.7%) underwent cardiac or thoracic surgery. There were 125 patients allocated to prophylactic NIV and 128 to usual care. Unplanned treatment termination occurred in 58 subjects in the NIV group, which was linked to NIV discomfort for 36 subjects. There was no difference in the incidence of the primary outcome of postoperative acute respiratory failure between treatment groups (NIV: 30 of 125 subjects [24.0%] vs usual care: 35 of 128 subjects [27.3%]; OR 0.97 [0.90–1.04]; P=0.54).

Conclusions

Prophylactic NIV was difficult to implement after high-risk surgery because of low patient compliance. Prophylactic NIV did not prevent acute respiratory failure.

Clinical trial registration

NCT 03629431 and EudraCT 2017-001011-36.

中文翻译：

肺部并发症高风险患者的术后预防性间歇性无创通气与常规术后护理：一项多中心随机试验

背景

肺部并发症是手术后发病率和死亡率的重要原因。我们评估了无创通气 (NIV) 在预防术后急性呼吸衰竭方面的临床效果。

方法

这是一项开放的多中心随机试验，纳入了加泰罗尼亚手术患者呼吸风险评估 (ARISCAT) 评分≥45 分的择期或半紧急手术后肺部并发症高危患者。患者被随机分配到间歇性预防性面罩 NIV 6-8 小时^-1天或常规术后护理。主要结局是术后 7 天内院内急性呼吸衰竭。接受手术和术后拔管的患者被纳入改良的意向性治疗分析。结果以n (%) 和比值比 (OR) 以及 95% 置信区间表示。

结果

2017 年 11 月至 2019 年 10 月期间，266 名患者被随机分组，其中 253 名患者被纳入主要分析。其中，203 名 (80.2%) 为男性，平均年龄为 68 (11) 岁，ARISCAT 评分为 53 (6)；237 名受试者 (93.7%) 接受了心脏或胸部手术。有 125 名患者分配到预防性 NIV，128 名患者分配到常规护理。NIV 组中有 58 名受试者意外终止治疗，这与 36 名受试者的 NIV 不适有关。治疗组之间术后急性呼吸衰竭主要结局的发生率没有差异（NIV：125 名受试者中的 30 名 [24.0%] vs常规治疗：128 名受试者中的 35 名 [27.3%]；OR 0.97 [0.90–1.04] ；P = 0.54）。