Effect of EIT-guided PEEP Titration on the Prognosis of Patients With Moderate to Severe ARDS

Clinical Outcomes Clinical Trial

Official title:

Effect of EIT-guided PEEP Titration on the Prognosis of Patients With Moderate to Severe ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207202
• Other study ID #: 2021010065
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Southeast University, China
• Contact: ling liu, phD
• Phone: 86-25-83272201
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 376
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age=18 years

2. Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen [PaO2]:FiO2 ratio =200 mmHg with a PEEP =5 cmH2O)

3. Diagnosis of ARDS less than 72 hours

Exclusion Criteria:

1. Expected to be mechanically ventilated for less than 48 hours

2. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV

3. Undrained pneumothorax or subcutaneous emphysema

4. Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment

5. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)

6. Severe neuromuscular disease

7. Hemodynamic instability

8. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome

9. Severe other organs dysfunction with a low expected survival (7 days) or palliative care

10. Solid organ or hematologic tumors with the expected survival time less than 30 days

11. Participating in other clinical trials within 30 days

12. Pregnancy

13. Refusal to sign the informed consent

Related Conditions & MeSH terms

• Clinical Outcomes

Intervention

Device:
• electrical impedance tomography
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.

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood gas	blood gas and the change at each time point	28 day
Other	vital signs	HR, MAP, RR, SPO2, CVP, CO and so on at each time point	28 day
Other	Ventilator parameters and respiratory mechanics	VT, RR, PEEP, FiO2, compliance, resistance and so on	28 day
Primary	28-day mortality	mortality in Day 28	at day 28
Secondary	VFDs at day 28	defined as the number of days between successful weaning from MV and day 28 after study enrollment	at day 28
Secondary	Shock-free days at day 28	Shock-free days at day 28	at day 28
Secondary	Length of ICU stay	the survival rate(survival/total) during ICU stay	up to 24 months
Secondary	Length of hospital stay	the survival rate(survival/total) during hospital stay	up to 24 months
Secondary	The rate of successful weaning	Proportion of people who are not dependent on ventilator ventilation	at day 28
Secondary	Proportion requiring rescue therapies	Proportion of people who require rescue therapies	day 28
Secondary	Rate of pneumothorax	Rate of pneumothorax	day 28
Secondary	driving pressure	measurement as one index of respiratory compliance at day 0, 1, 2, 3, and 7 from enrollment	day 0, day 1, day 2, day 3, day 7
Secondary	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	at the time of enrollment
Secondary	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	up to 24 months
Secondary	respiratory rate	respiratory rate	up to 7 days
Secondary	number of shock and gastrointestinal hemorrhage	shock, and gastrointestinal hemorrhage	day 28