PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

ARDS, Human Clinical Trial

Official title:

EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307913
• Other study ID #: PEEP by EIT for ARDS
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2022
• Est. completion date: April 10, 2025

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: Yun Long
• Phone: 010-69152300
• Email: ly_icu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: April 10, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor

Exclusion Criteria:

1. Age < 18 years old and > 90 years old;

2. Pregnancy;

3. EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);

4. Severe intracranial hypertension;

5. Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);

6. Unstable hemodynamic status intorerable to lung recruitment and PEEP titration, judged by an attending intensivist; (This may be a transient criterion, since patients meeting this criterion might be included later if hemodynamics improves)

7. End status of disease;

8. Patients or their families refused to participate in the study

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome

Intervention

Other:
• EIT-guided PEEP
PEEP setting according to EIT
• Table-guided PEEP
PEEP setting according to the lower PEEP/FiO2 table

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in 28 days	Survival within 28 days from randomization	28 days
Secondary	Lenght of ICU stay	Length of hospital stay from randomization to ICU discharge	Maximum 6-months
Secondary	Lenght of hospital stay	Length of hospital stay from randomization to hospital discharge	Maximum 6-months
Secondary	28-day ventilator-free days	Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.	28 days
Secondary	Barotrauma	We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele > 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures.	7 days
Secondary	ICU survival	Survival at ICU discharge.	Maximum 6-months
Secondary	hospital survival	Survival at hospital discharge.	Maximum 6-months
Secondary	change of Sequential Organ Failure Assessment (SOFA) score	change of SOFA score within first 2 days	2 days