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

NCT06671015 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-13

No results posted yet for this study

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)

Conditions

Interventions

DEVICE

Airvo 3

Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.

Sponsors & Collaborators

  • Fisher & Paykel Healthcare Limited

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Elliott Miller, MD, MS · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-04
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671015 on ClinicalTrials.gov