- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04359251
Different PEEP Settings of COVID-19 Induced ARDS
April 21, 2020 updated by: Chun Pan, Southeast University, China
Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study
This was a multi-center prospective study.
All consecutive severe cases of COVID-19 whose PO2/FiO2<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included.
Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet.
The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University.
Study Overview
Status
Completed
Detailed Description
After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.
Study Type
Interventional
Enrollment (Actual)
20
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 Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Southeast University
-
-
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:
- COVID-19 patients with mechanical ventilation
- PO2/FIO2<300mmHg
- ages>18 years
Exclusion Criteria:
- pneumothorax
- pregnant
- hemodynamics is unstable
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: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Optimizing oxygenation
Best oxygenation during PEEP titration
|
Gas exchanges measurement at different PEEP
|
|
Experimental: Optimizing compliance
Best compliance during PEEP titration
|
lung mechanics measurement at different PEEP
|
|
Experimental: ARDSnet
PEEP settings according to ARDSnet table
|
Hemodynamics changes measurement at different PEEP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory system compliance improvement
Time Frame: 20 minutes
|
the respiratory system compliance was compared among three groups
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gas echanges improvement
Time Frame: 20 minutes
|
P/Fwere compared among three groups
|
20 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hemodynamics improvement
Time Frame: 20 minutes
|
MAP were compared among three groups
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chun C Pan, Zhongda hospital, Southeast University, Jiangsu, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
March 5, 2020
Primary Completion (Actual)
March 25, 2020
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
April 13, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- COVID-19 PEEP titration
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.