- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734340
The Study of EIT-guided Ventilation Strategy on ARDS Patients
January 28, 2021 updated by: Peking Union Medical College Hospital
This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Long
- Phone Number: 13911608699
- Email: ly_icu@aliyun.com
Study Contact Backup
- Name: Siyi Yuan
- Phone Number: 15201518815
- Email: yuansiyizqh@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Yun Long
- Phone Number: 13911608699
- Email: ly_icu@aliyun.com
-
Contact:
- Siyi Yuan
- Phone Number: 15201518815
- Email: yuansiyizqh@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- According to ARDS Berlin standard, ARDS, PaO2 / FiO2 < 200mmhg, peep > 5cmh2o;
- According to clinical judgment, lung recruitment therapy is needed due to hypoxemia;
- The subjects or their families signed informed consent.
- Admission to ICU was less than 72 hours;
- The estimated duration of mechanical ventilation was more than or equal to 48 hours;
- Age ≥ 18 years old and ≤ 80 years old;
Exclusion Criteria:
- The patients with heart implants could not be monitored by EIT;
- Patients or their families refused to participate in the study;
- Hypernatremia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EIT-guided group
Treatment based on EIT
|
Ventilator parameter setting by EIT
|
Placebo Comparator: Control group
Treatment based on ARDS-net Peep setting
|
Ventilator parameter setting according to ARDS-net table
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ventilation free days
Time Frame: 1 Day
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28-day mortality
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
January 28, 2021
First Submitted That Met QC Criteria
January 28, 2021
First Posted (Actual)
February 2, 2021
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EIT-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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