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Pressure control plus spontaneous ventilation versus volume assist-control ventilation in acute respiratory distress syndrome. A randomised clinical trial
Intensive Care Medicine ( IF 27.1 ) Pub Date : 2024-09-17 , DOI: 10.1007/s00134-024-07612-3
Jean-Christophe M Richard 1, 2 , François M Beloncle 1 , Gaëtan Béduneau 3 , Satar Mortaza 1, 4 , Stephan Ehrmann 5 , Jean-Luc Diehl 6 , Gwenaël Prat 7 , Samir Jaber 8 , Hassene Rahmani 9 , Jean Reignier 10 , Thierry Boulain 11 , Hodane Yonis 12 , Jack Richecoeur 13 , Arnaud W Thille 14 , Pierre-Louis Declercq 15 , Emmanuel Antok 16 , Guillaume Carteaux 17 , Bruno Vielle 18 , Laurent Brochard 19 , Alain Mercat 1 ,
Affiliation  

Purpose

The aim of this study was to compare the effect of a pressure-controlled strategy allowing non-synchronised unassisted spontaneous ventilation (PC-SV) to a conventional volume assist-control strategy (ACV) on the outcome of patients with acute respiratory distress syndrome (ARDS).

Methods

Open-label randomised clinical trial in 22 intensive care units (ICU) in France. Seven hundred adults with moderate or severe ARDS (PaO2/FiO2 < 200 mmHg) were enrolled from February 2013 to October 2018. Patients were randomly assigned to PC-SV (n = 348) or ACV (n = 352) with similar objectives of tidal volume (6 mL/kg predicted body weight) and positive end-expiratory pressure (PEEP). Paralysis was stopped after 24 h and sedation adapted to favour patients’ spontaneous ventilation. The primary endpoint was in-hospital death from any cause at day 60.

Results

Hospital mortality [34.6% vs 33.5%, p = 0.77, risk ratio (RR) = 1.03 (95% confidence interval [CI] 0.84–1.27)], 28-day mortality, as well as the number of ventilator-free days and organ failure-free days at day 28 did not differ between PC-SV and ACV groups. Patients in the PC-SV group received significantly less sedation and neuro-muscular blocking agents than in the ACV group. A lower proportion of patients required adjunctive therapy of hypoxemia (including prone positioning) in the PC-SV group than in the ACV group [33.1% vs 41.3%, p = 0.03, RR = 0.80 (95% CI 0.66–0.98)]. The incidences of pneumothorax and refractory hypoxemia did not differ between the groups.

Conclusions

A strategy based on PC-SV mode that favours spontaneous ventilation reduced the need for sedation and adjunctive therapies of hypoxemia but did not significantly reduce mortality compared to ACV with similar tidal volume and PEEP levels.



中文翻译:


急性呼吸窘迫综合征中的压力控制加自主通气与容量辅助控制通气的比较。一项随机临床试验


 目的


本研究的目的是比较允许非同步非同步自主通气 (PC-SV) 的压力控制策略与传统容量辅助控制策略 (ACV) 对急性呼吸窘迫综合征 (ARDS) 患者预后的影响。

 方法


在法国 22 个重症监护病房 (ICU) 进行的开放标签随机临床试验。2013 年 2 月至 2018 年 10 月,纳入了 700 例患有中度或重度 ARDS (PaO2/FiO2 <, 200 mmHg) 的成人患者。患者被随机分配到 PC-SV (n = 348) 或 ACV (n = 352),潮气量 (6 mL/kg 预测体重) 和呼气末正压 (PEEP) 目标相似。24 小时后停止麻痹,镇静剂适应患者的自主通气。主要终点是第 60 天全因导致的院内死亡。

 结果


住院死亡率 [34.6% vs 33.5%,p = 0.77,风险比 (RR) = 1.03 (95% 置信区间 [CI] 0.84-1.27)]、28 天死亡率以及第 28 天无呼吸机天数和无器官衰竭天数在 PC-SV 和 ACV 组之间没有差异。PC-SV 组患者接受的镇静和神经肌肉阻滞剂明显少于 ACV 组。PC-SV 组需要低氧血症辅助治疗(包括俯卧位)的患者比例低于 ACV 组 [33.1% vs 41.3%,p = 0.03,RR = 0.80 (95% CI 0.66–0.98)]。气胸和难治性低氧血症的发生率在两组之间没有差异。

 结论


基于有利于自主通气的 PC-SV 模式策略减少了对低氧血症镇静和辅助治疗的需求,但与潮气量和 PEEP 水平相似的 ACV 相比,并未显著降低死亡率。

更新日期:2024-09-17
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