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A Prospective Randomized Controlled Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective, open-label randomized controlled pilot trial will enroll participants at the Yale New Haven Hospital. Patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (IMV) and are admitted to either the cardiac intensive care unit (CICU) or medical ICU (MICU) will be included. Subjects meeting eligibility criteria will be randomized 1:1 to one of the two treatment groups: * Intervention: Extubation to high-flow nasal cannula (HFNC) * Control: Extubation to non-invasive ventilation (NIV)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patient is a male or non-pregnant female greater than or equal to 18 years of age

• The patient is ventilated for greater than 24 hours

• The patient has a systolic left ventricular dysfunction defined as an ejection fraction less than or equal to 40%

• The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Locations
United States
Connecticut
Yale New Haven Hospital (CICU or MICU)
RECRUITING
New Haven
Contact Information
Primary
Elliott Miller, MD, MS
elliott.miller@yale.edu
203-737-6390
Time Frame
Start Date: 2025-10-04
Estimated Completion Date: 2026-02
Participants
Target number of participants: 50
Treatments
Experimental: Extubation to HFNC
Immediately after planned extubation, the patients assigned to the HFNC group will be continuously treated by HFNC at a flow at the maximally tolerated level for 24 hours.
Active_comparator: Control: Extubation to NIV for 24hrs post-extubation.
The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours.
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Fisher & Paykel Healthcare Limited

This content was sourced from clinicaltrials.gov