Comparison Between Limited Driving Pressure Ventilation a... | NCT04035915

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

NCT04035915

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Sep 24, 2021Actual

Enrollment

126Actual

Phase

Not Applicable

Conditions

on Invasive Mechanical Ventilation
ARDS
Respiratory Failure

Interventions

Limited driving pressure
Conventional mechanical ventilation strategies

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Jul 25, 2019

First Submission Date that Met QC Criteria

Jul 25, 2019

First Posted Date

Jul 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2021

Last Update Posted Date

Sep 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Limited driving pressure ventilation	Experimental		Procedure: Limited driving pressure
Conventional mechanical ventilation strategies	Experimental		Procedure: Conventional mechanical ventilation strategies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Limited driving pressure	Procedure	Keep driving pressure <15 cmH2O	Limited driving pressure ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung injury score	Lung injury score (LIS, Murray score)	Day 7 after invasive mechanical ventilation

Secondary Outcomes

Measure	Description	Time Frame
28 days Mortality	28 days Mortality	Upto 28 days
New onset of ARDS	New onset of ARDS	Upto 28 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Surat Tongyoo, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahidol university		Bangkok Noi	Bangkok	10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38726850	Derived	Tongyoo S, Viarasilpa T, Deawtrakulchai P, Subpinyo S, Suppasilp C, Permpikul C. Comparison of limited driving pressure ventilation and low tidal volume strategies in adults with acute respiratory failure on mechanical ventilation: a randomized controlled trial. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241249152. doi: 10.1177/17534666241249152.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases