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Generating Evidence in ECMO Ventilation Strategies

NCT05708365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-11-21

No results posted yet for this study

Summary

The goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. The main questions it aims to answer are:

* will clinicians closely follow different ICU ventilator protocols
* will different ICU ventilator protocols change the way that patients are treated.

Participants will be assigned to one of two ventilator protocols based on the month that they are first started on ECMO. Researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.

Conditions

  • ARDS
  • Acute Respiratory Failure

Interventions

OTHER

Standard-Lung Protective Ventilation

ICU ventilator protocol adhering to the following lung protective ventilation strategy: * Plateau Pressure ≤ 30 cm of water * PEEP and FiO2 set according to ARDSnet table * Driving Pressure ≤ 15 cm of water * Respiratory rate between 8 and 30 breaths per minute

OTHER

Ultra-Lung Protective Ventilation

ICU ventilator protocol adhering to the following lung protective ventilation strategy: * Plateau Pressure ≤ 30 cm of water * PEEP and FiO2 set according to ARDSnet table * Driving Pressure ≤ 15 cm of water * Respiratory rate between 8 and 30 breaths per minute

Sponsors & Collaborators

Principal Investigators

  • Elias H Pratt, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-07-21
Completion
2024-08-25

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05708365 on ClinicalTrials.gov