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Different PEEP Settings of COVID-19 Induced ARDS

Primary Purpose

COVID-19, Mechanical Ventilation Pressure High, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gas exchanges at different PEEP
lung mechanics at different PEEP
Hemodynamics changes at different PEEP
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring ARDS, COVID-19, mechanical ventilation, PEEP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID-19 patients with mechanical ventilation
  • PO2/FIO2<300mmHg
  • ages>18 years

Exclusion Criteria:

  • pneumothorax
  • pregnant
  • hemodynamics is unstable

Sites / Locations

  • Zhongda Hospital, Southeast University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Optimizing oxygenation

Optimizing compliance

ARDSnet

Arm Description

Best oxygenation during PEEP titration

Best compliance during PEEP titration

PEEP settings according to ARDSnet table

Outcomes

Primary Outcome Measures

Respiratory system compliance improvement
the respiratory system compliance was compared among three groups

Secondary Outcome Measures

Gas echanges improvement
P/Fwere compared among three groups

Full Information

First Posted
April 13, 2020
Last Updated
April 21, 2020
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04359251
Brief Title
Different PEEP Settings of COVID-19 Induced ARDS
Official Title
Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

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 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.
Detailed Description
After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Mechanical Ventilation Pressure High, Acute Respiratory Distress Syndrome
Keywords
ARDS, COVID-19, mechanical ventilation, PEEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimizing oxygenation
Arm Type
Experimental
Arm Description
Best oxygenation during PEEP titration
Arm Title
Optimizing compliance
Arm Type
Experimental
Arm Description
Best compliance during PEEP titration
Arm Title
ARDSnet
Arm Type
Experimental
Arm Description
PEEP settings according to ARDSnet table
Intervention Type
Other
Intervention Name(s)
Gas exchanges at different PEEP
Intervention Description
Gas exchanges measurement at different PEEP
Intervention Type
Other
Intervention Name(s)
lung mechanics at different PEEP
Intervention Description
lung mechanics measurement at different PEEP
Intervention Type
Other
Intervention Name(s)
Hemodynamics changes at different PEEP
Intervention Description
Hemodynamics changes measurement at different PEEP
Primary Outcome Measure Information:
Title
Respiratory system compliance improvement
Description
the respiratory system compliance was compared among three groups
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Gas echanges improvement
Description
P/Fwere compared among three groups
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
hemodynamics improvement
Description
MAP were compared among three groups
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID-19 patients with mechanical ventilation PO2/FIO2<300mmHg ages>18 years Exclusion Criteria: pneumothorax pregnant hemodynamics is unstable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun C Pan
Organizational Affiliation
Zhongda hospital, Southeast University, Jiangsu, China
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34355001
Citation
Pan C, Lu C, She X, Ren H, Wei H, Xu L, Huang Y, Xia J, Yu Y, Chen L, Du B, Qiu H. Evaluation of Positive End-Expiratory Pressure Strategies in Patients With Coronavirus Disease 2019-Induced Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2021 Jul 20;8:637747. doi: 10.3389/fmed.2021.637747. eCollection 2021.
Results Reference
derived

Learn more about this trial

Different PEEP Settings of COVID-19 Induced ARDS

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