Generating Evidence in ECMO Ventilation Strategies

NCT05708365 | Completed

• 1 other identifier: Pro00110840
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; Acute Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Duration of ECMO

  From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks

• Duration of mechanical ventilation

  From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks

• Duration of ICU admission

  From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks

• Duration of Hospital admission

  From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks

• Survival to discharge

  From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks

Study Arms (2)

Standard-Lung Protective Ventilation

ACTIVE COMPARATOR

Other: Ultra-Lung Protective Ventilation

Ultra-Lung Protective Ventilation

ACTIVE COMPARATOR

Other: Standard-Lung Protective Ventilation

Interventions

Standard-Lung Protective Ventilation 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

Ultra-Lung Protective Ventilation 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

Standard-Lung Protective Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Elias H Pratt, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 1, 2023
• Study Start: March 1, 2023
• Primary Completion: July 21, 2024
• Study Completion: August 25, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)