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ART-2 Pilot - Driving Pressure Limited Ventilation for Patients With ARDS

NCT02365038 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-28

No results posted yet for this study

Summary

This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS).

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

OTHER

Driving pressure limited ventilation

We will use volume controlled ventilation or pressure support in the weaning phase. We will adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). We will not limit plateau pressure in this arm.

OTHER

Conventional ventilation

ARDSNet Strategy: conventional mechanical ventilation strategy with tidal volume between 4 and 6 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre B Cavalcanti, MD, PhD · Hospital do Coracao (Heart Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-12
Primary Completion
2017-02-25
Completion
2017-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365038 on ClinicalTrials.gov