Generating Evidence in ECMO Ventilation Strategies (GENIE-Vent)

Generating Evidence in ECMO Ventilation Strategies - A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS; Acute Respiratory Failure
• Intervention / Treatment: Other: Ultra-Lung Protective Ventilation; Other: Standard-Lung Protective Ventilation

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elias H Pratt, MD; Phone Number: 9192593214; Email: elias.pratt@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Elias H Pratt, MD; Email: elias.pratt@duke.edu

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol fidelity rate	Percentage of days that a patient's ventilator settings adhere to assigned protocol	From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of ECMO	Total number of days a patient is supported with ECMO	From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
Duration of mechanical ventilation	Total number of days a patient is supported with mechanical ventilation	From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks
Duration of ICU admission	Total number of days a patient is cared for in the ICU	From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Duration of Hospital admission	Total number of days patient is admitted to the hospital	From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Survival to discharge	Whether a patient survives until hospital discharge	From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Time to meeting criteria for ECMO weaning	Total number of days between enrollment and when a patient meets criteria for ECMO weaning	From study enrollment until meeting weaning criteria or death, whichever comes first, up to 52 weeks
Time to first ECMO weaning trial	Total number of days between enrollment and when a patient first has an ECMO weaning trial	From study enrollment until first weaning trial or death, whichever comes first, up to 52 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: mechanical ventilation; lung protective ventilation; extracorporeal membrane oxygenation; ultra-lung protective ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Pro00110840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No