EIT 指导下的 PEEP 滴定对中重度 ARDS 患者预后的影响：一项多中心随机对照试验的研究方案。

Effect of EIT-guided PEEP titration on prognosis of patients with moderate to severe ARDS: study protocol for a multicenter randomized controlled trial.

机构信息

Jiangsu Provincial Key Laboratory of Critical Care Medicine, Department of Critical Care Medicine, School of Medicine, Zhongda Hospital, Southeast University, Nanjing, 210009, Jiangsu, China.

Department of Critical Care Medicine, The First People's Hospital of Yancheng, Yancheng, 224000, Jiangsu, China.

出版信息

Trials. 2023 Apr 11;24(1):266. doi: 10.1186/s13063-023-07280-6.

DOI:10.1186/s13063-023-07280-6

PMID:37041561

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10088128/

Abstract

BACKGROUND

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Electrical impedance tomography (EIT)-guided positive end-expiratory pressure (PEEP) titration can achieve the compromise between lung overdistension and collapse which may minimize ventilator-induced lung injury in these patients. However, the effect of EIT-guided PEEP titration on the clinical outcomes remains unknown. The objective of this trial is to investigate the effects of EIT-guided PEEP titration on the clinical outcomes for moderate or severe ARDS, compared to the low fraction of inspired oxygen (FiO)-PEEP table.

METHODS

This is a prospective, multicenter, single-blind, parallel-group, adaptive designed, randomized controlled trial (RCT) with intention-to-treat analysis. Adult patients with moderate to severe ARDS less than 72 h after diagnosis will be included in this study. Participants in the intervention group will receive PEEP titrated by EIT with a stepwise decrease PEEP trial, whereas participants in the control group will select PEEP based on the low FiO-PEEP table. Other ventilator parameters will be set according to the ARDSNet strategy. Participants will be followed up until 28 days after enrollment. Three hundred seventy-six participants will be recruited based on a 15% decrease of 28-day mortality in the intervention group, with an interim analysis for sample size re-estimation and futility assessment being undertaken once 188 participants have been recruited. The primary outcome is 28-day mortality. The secondary outcomes include ventilator-free days and shock-free days at day 28, length of ICU and hospital stay, the rate of successful weaning, proportion requiring rescue therapies, compilations, respiratory variables, and Sequential Organ Failure Assessment (SOFA).

DISCUSSION

As a heterogeneous syndrome, ARDS has different responses to treatment and further results in different clinical outcomes. PEEP selection will depend on the properties of patients and can be individually achieved by EIT. This study will be the largest randomized trial to investigate thoroughly the effect of individual PEEP titrated by EIT in moderate to severe ARDS patients to date.

TRIAL REGISTRATION

ClinicalTrial.gov NCT05207202. First published on January 26, 2022.

摘要

背景

急性呼吸窘迫综合征（ARDS）是一种临床常见的综合征，死亡率较高。电传导断层成像（EIT）指导的呼气末正压（PEEP）滴定可在避免肺过度膨胀和塌陷之间取得平衡，从而最大限度地减少这些患者的呼吸机相关性肺损伤。然而，EIT 指导的 PEEP 滴定对临床结局的影响尚不清楚。本试验的目的是研究 EIT 指导的 PEEP 滴定对中重度 ARDS 患者的临床结局的影响，与低吸氧分数（FiO）-PEEP 表相比。

方法

这是一项前瞻性、多中心、单盲、平行组、适应性设计、随机对照试验（RCT），采用意向治疗分析。诊断后 72 小时内患有中重度 ARDS 的成年患者将被纳入本研究。干预组的患者将接受 EIT 指导的 PEEP 滴定，逐步降低 PEEP 试验，而对照组的患者将根据低 FiO-PEEP 表选择 PEEP。其他呼吸机参数将根据 ARDSNet 策略设置。参与者将随访至纳入后 28 天。根据干预组 28 天死亡率降低 15%的目标，预计招募 376 名参与者，一旦招募了 188 名参与者，将进行中期分析以重新估计样本量和评估无效性。主要结局是 28 天死亡率。次要结局包括第 28 天无呼吸机天数和无休克天数、ICU 和住院时间、成功撤机率、需要抢救治疗的比例、并发症、呼吸变量和序贯器官衰竭评估（SOFA）。