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NCT04035915 Clinical Trial

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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04035915
Other study ID # SI828/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2019
Est. completion date March 31, 2021

Study information
Verified date September 2021
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date March 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Limited driving pressure
Keep driving pressure <15 cmH2O
• Conventional mechanical ventilation strategies
Keep tidalvolume </= 8

Locations
Country Name City State
Thailand Mahidol university Bangkok Noi Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lung injury score Lung injury score (LIS, Murray score) Day 7 after invasive mechanical ventilation
Secondary 28 days Mortality 28 days Mortality Upto 28 days
Secondary New onset of ARDS New onset of ARDS Upto 28 days
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