- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035915
Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
-
Bangkok Noi, Bangkok, Thailand, 10700
- Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Limited driving pressure ventilation
|
Keep driving pressure <15 cmH2O
|
Experimental: Conventional mechanical ventilation strategies
|
Keep tidalvolume
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung injury score
Time Frame: Day 7 after invasive mechanical ventilation
|
Lung injury score (LIS, Murray score)
|
Day 7 after invasive mechanical ventilation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28 days Mortality
Time Frame: Upto 28 days
|
28 days Mortality
|
Upto 28 days
|
New onset of ARDS
Time Frame: Upto 28 days
|
New onset of ARDS
|
Upto 28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Surat Tongyoo, MD, Mahidol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SI828/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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