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OpenTrials
Completed

NCT Number: NCT04035915

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

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.

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Key information

Conditions

on Invasive Mechanical Ventilation ARDS Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limited driving pressure

Procedure

Keep driving pressure <15 cmH2O

Conventional mechanical ventilation strategies

Procedure

Keep tidalvolume </= 8

Primary outcomes

  1. Lung injury score

    Time frame: Day 7 after invasive mechanical ventilation

    Lung injury score (LIS, Murray score)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 29, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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