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Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19)

NCT04497454 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-05-11

No results posted yet for this study

Summary

This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.

Conditions

  • Respiratory Distress Syndrome
  • Mechanical Ventilation
  • SARS (Severe Acute Respiratory Syndrome)

Interventions

OTHER

EIT-Group

A mechanical ventilation strategy with the main goal to maintain DP \< 16 cmH2O

OTHER

ARDSNet

Low PEEP-FiO2 table ARDS Network ventilation protocol

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Eduardo LV Costa, PhD · Hospital das Clinicas from University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2022-07-01
Completion
2022-12-01

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 NCT04497454 on ClinicalTrials.gov