Generating Evidence in ECMO Ventilation Strategies (GENIE-Vent)

• ClinicalTrials.gov Identifier: NCT05708365
• Recruitment Status: Recruiting
• First Posted: February 1, 2023
• Last Update Posted: March 2, 2023
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
ARDS; Acute Respiratory Failure	Other: Standard-Lung Protective Ventilation; Other: Ultra-Lung Protective Ventilation	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Generating Evidence in ECMO Ventilation Strategies - A Pilot Study
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: October 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard-Lung Protective Ventilation	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
Active Comparator: Ultra-Lung Protective Ventilation	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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Elias H Pratt, MD; 9192593214; elias.pratt@duke.edu

Locations

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27710

Contact: Elias H Pratt, MD elias.pratt@duke.edu

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Christopher E. Cox, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05708365
• Other Study ID Numbers: Pro00110840
• First Posted: February 1, 2023
• Last Update Posted: March 2, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

extracorporeal membrane oxygenation; mechanical ventilation; lung protective ventilation; ultra-lung protective ventilation

Additional relevant MeSH terms:

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases