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Different PEEP Settings of COVID-19 Induced ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359251
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Chun Pan, Southeast University, China

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.

Condition or disease Intervention/treatment Phase
COVID-19 Mechanical Ventilation Pressure High Acute Respiratory Distress Syndrome Other: Gas exchanges at different PEEP Other: lung mechanics at different PEEP Other: Hemodynamics changes at different PEEP Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study
Actual Study Start Date : March 5, 2020
Actual Primary Completion Date : March 25, 2020
Actual Study Completion Date : March 25, 2020


Arm Intervention/treatment
Experimental: Optimizing oxygenation
Best oxygenation during PEEP titration
Other: Gas exchanges at different PEEP
Gas exchanges measurement at different PEEP

Experimental: Optimizing compliance
Best compliance during PEEP titration
Other: lung mechanics at different PEEP
lung mechanics measurement at different PEEP

Experimental: ARDSnet
PEEP settings according to ARDSnet table
Other: Hemodynamics changes at different PEEP
Hemodynamics changes measurement at different PEEP




Primary Outcome Measures :
  1. Respiratory system compliance improvement [ Time Frame: 20 minutes ]
    the respiratory system compliance was compared among three groups


Secondary Outcome Measures :
  1. Gas echanges improvement [ Time Frame: 20 minutes ]
    P/Fwere compared among three groups


Other Outcome Measures:
  1. hemodynamics improvement [ Time Frame: 20 minutes ]
    MAP were compared among three groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pneumothorax
  • pregnant
  • hemodynamics is unstable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359251


Locations
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China, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
Investigators
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Study Director: Chun C Pan Zhongda hospital, Southeast University, Jiangsu, China
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Responsible Party: Chun Pan, Dr, Southeast University, China
ClinicalTrials.gov Identifier: NCT04359251    
Other Study ID Numbers: COVID-19 PEEP titration
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chun Pan, Southeast University, China:
ARDS
COVID-19
mechanical ventilation
PEEP
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury