ABC试验和先导试验期间SAT与SBT实施情况的比较

Comparison of SAT and SBT Conduct During the ABC Trial and PILOT Trial.

作者信息

Alkhateeb Tuqa, Semler Matthew W, Girard Timothy D, Ely E Wesley, Stollings Joanna L

机构信息

The Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

J Intensive Care Med. 2025 Jan;40(1):3-9. doi: 10.1177/08850666231213337. Epub 2023 Nov 19.

DOI:10.1177/08850666231213337

PMID:37981753

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11622525/

Abstract

BACKGROUND

Implementation of the "B" element-both spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs)-of the ABCDEF bundle improves the outcomes for mechanically ventilated patients. In 2021, the Pragmatic Investigation of optimal Oxygen Targets (PILOT) trial investigating optimal oxygenation targets in patients on mechanical ventilation was completed.

OBJECTIVES

To compare SAT and SBT conduct between a randomized controlled trial and current clinical care.

METHODS

The 2008 Awakening and Breathing Controlled (ABC) Trial (2003-2006) randomized mechanically ventilated patients to paired SATs and SBTs versus sedation per usual care plus SBTs. The PILOT trial (2018-2021) enrolled patients years later where SAT + SBT conduct was observed. We compared SAT and SBT conduct in ABC's interventional group (SAT + SBT; n = 167, 1140 patient days) to that in PILOT (n = 2083, 8355 patient days).

RESULTS

Spontaneous awakening trial safety screens were done in all 1140 ABC patient-days on sedation and/or analgesia and in 3889 of 4228 (92%) in PILOT. Spontaneous awakening trial safety screens were passed in 939 of 1140 (82%) instances in ABC versus only 1897 of 3889 (49%) in PILOT. Interestingly, SAT was performed in ≥95% of passed SAT safety screens in both trials and was passed in 837 of 895 (94%) in ABC versus 1145 of 1867 (61%) in PILOT. SBT safety screens were performed in all 983 ABC instances and 8031 of 8370 (96%) in PILOT. SBT safety screens were passed in 647 of 983 (66%) in ABC versus 4475 of 8031 (56%) in PILOT. Spontaneous breathing trial was performed in ≥93% of passed SBT safety screens in both trials and was passed in 319 of 603 (53%) in ABC versus 3337 of 4454 (75%) in PILOT.

CONCLUSION

This study compared SAT/SBT conduction in an ideal setting to real-world practice, 13 years later. Performance of SAT/SBT safety screens, SATs, and SBTs between a definitive clinical trial (ABC) as compared to current clinical care (PILOT) remained high.

摘要

背景

实施ABCDEF集束化方案中的“B”要素，即自主唤醒试验（SATs）和自主呼吸试验（SBTs），可改善机械通气患者的预后。2021年，一项关于机械通气患者最佳氧合目标的实用研究（PILOT）试验完成。

目的

比较随机对照试验与当前临床护理中SAT和SBT的实施情况。

方法

2008年的唤醒与呼吸控制（ABC）试验（2003 - 2006年）将机械通气患者随机分为接受配对SATs和SBTs组与常规护理加镇静剂加SBTs组。多年后，PILOT试验（2018 - 2021年）纳入患者并观察SAT + SBT的实施情况。我们将ABC试验干预组（SAT + SBT；n = 167，1140个患者日）的SAT和SBT实施情况与PILOT试验（n = 2083，8355个患者日）进行比较。

结果

在ABC试验的所有1140个患者日的镇静和/或镇痛期间均进行了自主唤醒试验安全筛查，在PILOT试验的4228例中有3889例（92%）进行了该筛查。ABC试验中1140例中有939例（82%）通过了自主唤醒试验安全筛查，而PILOT试验中3889例中只有1897例（49%）通过。有趣的是，在两项试验中，≥95%通过SAT安全筛查的病例进行了SAT，ABC试验中895例中有837例（94%）通过，而PILOT试验中1867例中有1145例（61%）通过。ABC试验的所有983例和PILOT试验的8370例中有8031例（96%）进行了SBT安全筛查。ABC试验中983例中有647例（66%）通过了SBT安全筛查，而PILOT试验中8031例中有4475例（56%）通过。在两项试验中，≥93%通过SBT安全筛查的病例进行了自主呼吸试验，ABC试验中603例中有319例（53%）通过，而PILOT试验中4454例中有3337例（75%）通过。