Generating Evidence in ECMO Ventilation Strategies

ARDS Clinical Trial

— GENIE-Vent  

Official title:

Generating Evidence in ECMO Ventilation Strategies - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708365
• Other study ID #: Pro00110840
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Elias H Pratt, MD
• Phone: 9192593214
• Email: elias.pratt[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• ARDS
• Respiratory Insufficiency

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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