Back to resultsPET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial
Primary Purpose
ARDS, Human
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EIT-guided PEEP
Table-guided PEEP
Sponsored by
About this trial
This is an interventional treatment trial for ARDS, Human focused on measuring electrical impedance tomography, ARDS, PEEP
Eligibility Criteria
Inclusion Criteria:
Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
Exclusion Criteria:
- Age < 18 years old and > 90 years old;
- Pregnancy;
- EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
- Severe intracranial hypertension;
- Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
- 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)
- End status of disease;
- Patients or their families refused to participate in the study
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EIT-guided PEEP
Table-guided PEEP
Arm Description
PEEP titration by EIT
PEEP selection by the lower PEEP/FiO2 table
Outcomes
Primary Outcome Measures
Survival in 28 days
Survival within 28 days from randomization
Secondary Outcome Measures
Lenght of ICU stay
Length of hospital stay from randomization to ICU discharge
Lenght of hospital stay
Length of hospital stay from randomization to hospital discharge
28-day ventilator-free days
Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
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.
ICU survival
Survival at ICU discharge.
hospital survival
Survival at hospital discharge.
change of Sequential Organ Failure Assessment (SOFA) score
change of SOFA score within first 2 days
Full Information
NCT ID
NCT05307913
First Posted
December 29, 2021
Last Updated
April 27, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05307913
Brief Title
PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial
Official Title
EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
April 10, 2025 (Anticipated)
Study Completion Date
April 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human
Keywords
electrical impedance tomography, ARDS, PEEP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EIT-guided PEEP
Arm Type
Experimental
Arm Description
PEEP titration by EIT
Arm Title
Table-guided PEEP
Arm Type
Active Comparator
Arm Description
PEEP selection by the lower PEEP/FiO2 table
Intervention Type
Other
Intervention Name(s)
EIT-guided PEEP
Intervention Description
PEEP setting according to EIT
Intervention Type
Other
Intervention Name(s)
Table-guided PEEP
Intervention Description
PEEP setting according to the lower PEEP/FiO2 table
Primary Outcome Measure Information:
Title
Survival in 28 days
Description
Survival within 28 days from randomization
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Lenght of ICU stay
Description
Length of hospital stay from randomization to ICU discharge
Time Frame
Maximum 6-months
Title
Lenght of hospital stay
Description
Length of hospital stay from randomization to hospital discharge
Time Frame
Maximum 6-months
Title
28-day ventilator-free days
Description
Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
Time Frame
28 days
Title
Barotrauma
Description
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.
Time Frame
7 days
Title
ICU survival
Description
Survival at ICU discharge.
Time Frame
Maximum 6-months
Title
hospital survival
Description
Survival at hospital discharge.
Time Frame
Maximum 6-months
Title
change of Sequential Organ Failure Assessment (SOFA) score
Description
change of SOFA score within first 2 days
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
Exclusion Criteria:
Age < 18 years old and > 90 years old;
Pregnancy;
EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
Severe intracranial hypertension;
Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
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)
End status of disease;
Patients or their families refused to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Long
Phone
010-69152300
Email
ly_icu@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huaiwu He
Phone
010-69152300
Email
hehuaiwu@pumch.cn
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Long, MD
Email
ly_icu@aliyun.com
First Name & Middle Initial & Last Name & Degree
Huaiwu He, MD
Email
hehuaiwu@pumch.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial
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