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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT04035915
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
20.2
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Limited driving pressure
  • Procedure: Conventional mechanical ventilation strategies
 N/A

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

Study Type:
Interventional
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 :
Jul 25, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Lung injury score [Day 7 after invasive mechanical ventilation]

    Lung injury score (LIS, Murray score)

Secondary Outcome Measures

  1. 28 days Mortality [Upto 28 days]

    28 days Mortality

  2. New onset of ARDS [Upto 28 days]

    New onset of ARDS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mahidol university Bangkok Noi Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Surat Tongyoo, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT04035915
Other Study ID Numbers:
  • SI828/2016
First Posted:
Jul 29, 2019
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Respiratory Insufficiency

Study Results

No Results Posted as of Sep 24, 2021