NCT04035915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

July 25, 2019

Last Update Submit

September 23, 2021

Conditions

on Invasive Mechanical VentilationARDSRespiratory Failure

Keywords

Limited driving pressureLow tidal volumeLung injury score

Outcome Measures

Primary Outcomes (1)

  • Lung injury score

    Lung injury score (LIS, Murray score)

    Day 7 after invasive mechanical ventilation

Secondary Outcomes (2)

  • 28 days Mortality

    Upto 28 days

  • New onset of ARDS

    Upto 28 days

Study Arms (2)

Limited driving pressure ventilation

EXPERIMENTAL
Procedure: Limited driving pressure

Conventional mechanical ventilation strategies

EXPERIMENTAL
Procedure: Conventional mechanical ventilation strategies

Interventions

Limited driving pressurePROCEDURE

Keep driving pressure \<15 cmH2O

Limited driving pressure ventilation
Conventional mechanical ventilation strategiesPROCEDURE

Keep tidalvolume \</= 8

Conventional mechanical ventilation strategies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 year old MICU patient
  • On Invasive mechanical ventilator less than 24 hr. before randomization

You may not qualify if:

  • Suspected death within 48 hr. after randomization
  • patients with tracheostomy tube
  • Pregnancy
  • Do not attempt resuscitation order
  • Patient with ECMO before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 38726850DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Surat Tongyoo, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

July 29, 2019

Study Start

July 25, 2019

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Locations

TH(1)