Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes.
This is a prospective, multicenter, single-blind, parallel-group, adaptive randomized controlled trial (RCT) with intention-to-treat analysis which aims to determine the effects of PEEP setting guided by EIT on the clinical outcomes for moderate or severe ARDS patients ventilated with lung protective ventilation strategy. Adult patients with moderate to severe ARDS less than 72 hours after diagnosis will be included in this study. Patients in the intervention group will receive PEEP titrated by EIT with a stepwise decrease PEEP trial, whereas patients in the control group will select PEEP based on the FiO2-PEEP table. Other ventilator parameters will be set according to the ARDSnet strategy. 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). This study will also perform the interim analysis and subgroup analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
190
PEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O and then reduced in steps of 2cmH2O from 20 to zero every 2min.
the First Affiliated Hospital of Guangzhou Medical University, Department of Critical Care Medicine
Guangzhou, Guangdong, China
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China
Department of Critical Care Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Department of Critical Care Medicine, Zhongshan Hospital of Fudan University
Shangha, Shangha, China
Department of ICU, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
28-day mortality
mortality in Day 28
Time frame: at day 28
VFDs at day 28
defined as the number of days between successful weaning from MV and day 28 after study enrollment
Time frame: at day 28
Shock-free days at day 28
Shock-free days at day 28
Time frame: at day 28
Length of ICU stay
the survival rate(survival/total) during ICU stay
Time frame: up to 24 months
Length of hospital stay
the survival rate(survival/total) during hospital stay
Time frame: up to 24 months
The rate of successful weaning
Proportion of people who are not dependent on ventilator ventilation
Time frame: at day 28
Proportion requiring rescue therapies
Proportion of people who require rescue therapies
Time frame: day 28
Rate of pneumothorax
Rate of pneumothorax
Time frame: day 28
driving pressure
measurement as one index of respiratory compliance at day 0, 1, 2, 3, and 7 from enrollment
Time frame: day 0, day 1, day 2, day 3, day 7
Sequential Organ Failure Assessment (SOFA) score at the time of enrollment
SOFA range from three to eight. The higher the score, the worse the prognosis
Time frame: at the time of enrollment
Blood pressure at day D1, 2, 3, and 7 from enrollment
Both systolic and diastolic pressure at day D1, 2, 3, and 7 from enrollment
Time frame: up to 24 months
respiratory rate
respiratory rate
Time frame: up to 7 days
number of shock and gastrointestinal hemorrhage
shock, and gastrointestinal hemorrhage
Time frame: day 28
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