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ART-3 Pilot - Driving Pressure Limited Ventilation for Patients Without ARDS (ART3pilot)

NCT02376647 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-09-22

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 a conventional strategy in patients without acute respiratory distress syndrome (ARDS).

Conditions

  • Mechanical Ventilation
  • Acute Respiratory Distress Syndrome

Interventions

OTHER

Driving pressure limited ventilation

Investigators will use volume controlled (or pressure support ventilation) and 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). Investigators will not limit plateau pressure in this arm. Once a daily the investigators will assess the target tidal volume that generates a driving pressure of 13cmH2O. The patient should be sedated and without spontaneous efforts during this assessment.

OTHER

Conventional ventilation

Investigators will use volume controlled or pressure support ventilation, tidal volume ≤8 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 35 breathings per minute).

Sponsors & Collaborators

  • Brazilian Research in Intensive Care Network (BRICNet)

    collaborator UNKNOWN

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre B Cavalcanti, MD, PhD · Hospital do Coração(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
2022-03-31
Primary Completion
2024-09-30
Completion
2024-10-31

Countries

  • Brazil

Study Locations

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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 NCT02376647 on ClinicalTrials.gov