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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05708365
Other study ID # Pro00110840
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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