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

Primary Purpose

on Invasive Mechanical Ventilation, ARDS, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Limited driving pressure
Conventional mechanical ventilation strategies
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for on Invasive Mechanical Ventilation focused on measuring Limited driving pressure, Low tidal volume, Lung injury score

Eligibility Criteria

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

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

Sites / Locations

  • Mahidol university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Limited driving pressure ventilation

Conventional mechanical ventilation strategies

Arm Description

Outcomes

Primary Outcome Measures

Lung injury score
Lung injury score (LIS, Murray score)

Secondary Outcome Measures

28 days Mortality
28 days Mortality
New onset of ARDS
New onset of ARDS

Full Information

First Posted
July 25, 2019
Last Updated
September 23, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04035915
Brief Title
Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
Official Title
Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
on Invasive Mechanical Ventilation, ARDS, Respiratory Failure
Keywords
Limited driving pressure, Low tidal volume, Lung injury score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Limited driving pressure ventilation
Arm Type
Experimental
Arm Title
Conventional mechanical ventilation strategies
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Limited driving pressure
Intervention Description
Keep driving pressure <15 cmH2O
Intervention Type
Procedure
Intervention Name(s)
Conventional mechanical ventilation strategies
Intervention Description
Keep tidalvolume </= 8
Primary Outcome Measure Information:
Title
Lung injury score
Description
Lung injury score (LIS, Murray score)
Time Frame
Day 7 after invasive mechanical ventilation
Secondary Outcome Measure Information:
Title
28 days Mortality
Description
28 days Mortality
Time Frame
Upto 28 days
Title
New onset of ARDS
Description
New onset of ARDS
Time Frame
Upto 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidol university
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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