Clinical trial NCT05708365: Generating Evidence in ECMO Ventilation Strategies
Official title: Generating Evidence in ECMO Ventilation Strategies - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Acute Respiratory Failure
Keywords: extracorporeal membrane oxygenation
mechanical ventilation
lung protective ventilation
ultra-lung protective ventilation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Protocol fidelity rate
timeFrame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
Secondary outcomes:
measure: Duration of ECMO
timeFrame: From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks
measure: Duration of mechanical ventilation
timeFrame: From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks
measure: Duration of ICU admission
timeFrame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
measure: Duration of Hospital admission
timeFrame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
measure: Survival to discharge
timeFrame: From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
measure: Time to meeting criteria for ECMO weaning
timeFrame: From study enrollment until meeting weaning criteria or death, whichever comes first, up to 52 weeks
measure: Time to first ECMO weaning trial
timeFrame: From study enrollment until first weaning trial or death, whichever comes first, up to 52 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Elias H Pratt, MD
role: PRINCIPAL_INVESTIGATOR
References: