Skip to main content
OpenTrials
Completed

NCT Number: NCT05708365

Generating Evidence in ECMO Ventilation Strategies

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ARDS Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

This is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of ICU-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ECMO). The overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. The investigators will do this by completion of the following aims:

Aim 1: Measure clinician fidelity to ICU-level ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Clinicians will have high fidelity to ICU-level ventilator management protocols for patients with severe ARDS on ECMO. To test this hypothesis, the investigators will conduct a pilot cluster-crossover study. The Duke medical ICU will be treated as a single cluster of patients. This cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ECMO, and then crossover to an ultra-lung protective ventilation protocol. The investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. The proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility.

Aim 2: Explore the clinical impact of using different ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Patients managed with standard lung protective ventilation will have shorter durations of ECMO and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. To test this hypothesis, the investigators will measure the duration of ECMO and mechanical ventilation for all patients enrolled in the study. The investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients being treated with ECMO in the Duke University Hospital Medical ICU will be eligible

Exclusion criteria

  • There are no exclusion criteria

Treatment and study plan

Standard-Lung Protective Ventilation

Other

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

Ultra-Lung Protective Ventilation

Other

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

Primary outcomes

  1. Protocol fidelity rate

    Time frame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks

    Percentage of days that a patient's ventilator settings adhere to assigned protocol

Secondary outcomes

  1. Duration of ECMO

    Time frame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks

    Total number of days a patient is supported with ECMO

  2. Duration of mechanical ventilation

    Time frame: From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks

    Total number of days a patient is supported with mechanical ventilation

  3. Duration of ICU admission

    Time frame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks

    Total number of days a patient is cared for in the ICU

  4. Duration of Hospital admission

    Time frame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks

    Total number of days patient is admitted to the hospital

  5. Survival to discharge

    Time frame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks

    Whether a patient survives until hospital discharge

  6. Time to meeting criteria for ECMO weaning

    Time frame: From study enrollment until meeting weaning criteria or death, whichever comes first, up to 52 weeks

    Total number of days between enrollment and when a patient meets criteria for ECMO weaning

  7. Time to first ECMO weaning trial

    Time frame: From study enrollment until first weaning trial or death, whichever comes first, up to 52 weeks

    Total number of days between enrollment and when a patient first has an ECMO weaning trial

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Generating Evidence in ECMO Ventilation Strategies - A Pilot Study

Acronym: GENIE-Vent

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.