Generating Evidence in ECMO Ventilation Strategies

NCT ID: NCT05708365

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-08-25

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.

Conditions

ARDS; Acute Respiratory Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard-Lung Protective Ventilation

Group Type: ACTIVE_COMPARATOR

Ultra-Lung Protective Ventilation

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Standard-Lung Protective Ventilation

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elias H Pratt, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00110840

Identifier Type: -

Identifier Source: org_study_id