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Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure

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: NCT04035915
Recruitment Status : Completed
First Posted : July 29, 2019
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Study Description
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Brief Summary:
Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.

Condition or disease Intervention/treatment Phase
on Invasive Mechanical Ventilation ARDS Respiratory Failure Procedure: Limited driving pressure Procedure: Conventional mechanical ventilation strategies Not Applicable

Detailed Description:

Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.

To compare lung injury score (LIS, Murray score) after invasive mechanical ventilation 7 days between groups of limited driving pressure ventilation versus low tidal volume ventilation strategies.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
Actual Study Start Date : July 25, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Limited driving pressure ventilation Procedure: Limited driving pressure
Keep driving pressure <15 cmH2O
Experimental: Conventional mechanical ventilation strategies Procedure: Conventional mechanical ventilation strategies
Keep tidalvolume </= 8


Outcome Measures
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Primary Outcome Measures :
  1. Lung injury score [ Time Frame: Day 7 after invasive mechanical ventilation ]
    Lung injury score (LIS, Murray score)


Secondary Outcome Measures :
  1. 28 days Mortality [ Time Frame: Upto 28 days ]
    28 days Mortality

  2. New onset of ARDS [ Time Frame: Upto 28 days ]
    New onset of ARDS


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 year old MICU patient
  • On Invasive mechanical ventilator less than 24 hr. before randomization

Exclusion Criteria:

  • Suspected death within 48 hr. after randomization
  • patients with tracheostomy tube
  • Pregnancy
  • Do not attempt resuscitation order
  • Patient with ECMO before randomization
Contacts and Locations
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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): NCT04035915


Locations
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Thailand
Mahidol university
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Surat Tongyoo, MD Mahidol University
More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04035915    
Other Study ID Numbers: SI828/2016
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Mahidol University:
Limited driving pressure
Low tidal volume
Lung injury score
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases