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

NCT ID: NCT04035915

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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on Invasive Mechanical Ventilation ARDS Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Limited driving pressure ventilation

Group Type EXPERIMENTAL

Limited driving pressure

Intervention Type PROCEDURE

Keep driving pressure \<15 cmH2O

Conventional mechanical ventilation strategies

Group Type EXPERIMENTAL

Conventional mechanical ventilation strategies

Intervention Type PROCEDURE

Keep tidalvolume \</= 8

Interventions

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Limited driving pressure

Keep driving pressure \<15 cmH2O

Intervention Type PROCEDURE

Conventional mechanical ventilation strategies

Keep tidalvolume \</= 8

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surat Tongyoo, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Mahidol university

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 38726850 (View on PubMed)

Other Identifiers

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SI828/2016

Identifier Type: -

Identifier Source: org_study_id

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