NCT04359251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

20 days

First QC Date

April 13, 2020

Last Update Submit

April 21, 2020

Conditions

Keywords

ARDSCOVID-19mechanical ventilationPEEP

Outcome Measures

Primary Outcomes (1)

  • Respiratory system compliance improvement

    the respiratory system compliance was compared among three groups

    20 minutes

Secondary Outcomes (1)

  • Gas echanges improvement

    20 minutes

Other Outcomes (1)

  • hemodynamics improvement

    20 minutes

Study Arms (3)

Optimizing oxygenation

EXPERIMENTAL

Best oxygenation during PEEP titration

Other: Gas exchanges at different PEEP

Optimizing compliance

EXPERIMENTAL

Best compliance during PEEP titration

Other: lung mechanics at different PEEP

ARDSnet

EXPERIMENTAL

PEEP settings according to ARDSnet table

Other: Hemodynamics changes at different PEEP

Interventions

Gas exchanges measurement at different PEEP

Optimizing oxygenation

lung mechanics measurement at different PEEP

Optimizing compliance

Hemodynamics changes measurement at different PEEP

ARDSnet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pneumothorax
  • pregnant
  • hemodynamics is unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Chun C Pan

    Zhongda hospital, Southeast University, Jiangsu, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 24, 2020

Study Start

March 5, 2020

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations