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

Not Applicable

Not yet recruiting

• Conditions: Systolic Heart Failure; Respiratory Failure

• Registration Number: NCT06671015
• Lead Sponsor: Yale University

Brief 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)

Detailed Description

The primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to HFNC or NIV. Reintubation will be at the discretion of the attending physician. In doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-11-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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).

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Exclusion Criteria

• Patients actively being treated for a COPD exacerbation or known hypercapnia (PaCO2>45) on last Arterial Blood Gas (ABG)
• Patients agitated or uncooperative state
• Patients with do-not-resuscitate orders
• Patients presenting with tracheostomies or anatomical abnormalities interfering with mask fit
• Patients are prisoners
• Patient self-extubates
• Patients with pre-existing NIV prescription (e.g., obstructive sleep apnea, neuromuscular disorders, advanced COPD)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation	up to 72 hours post-extubation	Number of participants with reintubation or respiratory failure within 72 hours post-extubation

Secondary Outcome Measures

Name	Time	Method
Incidence of Reintubation or respiratory failure	48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)	Number of participants that experience reintubation or respiratory failure (per specific, predetermined criteria) within 48 hours, 7 days, and up to ICU discharge (an average of 30 days)
Patient intolerance to assigned treatment	up to 24 hours post-extubation	Intolerance will be measured as the ability to continue the therapy for the 24 hour treatment period (yes/no).
Mean length of stay	up to 30 days post-extubation	Mean length of ICU and hospital stay in days
Incidence of ICU mortality	up to ICU discharge (an average of 30 days post-extubation)	Number of participants with mortality while in ICU
Hospital mortality	48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)	Number of participants with mortality while in hospital
Time to reintubation	Immediately post-extubation up to 30 days post-extubation	Mean number of hours to reintubation after extubation
Respiratory rate-oxygenation (ROX) index and vector	on day of extubation	The ROX index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR), is used as a predictor of the need to intubate in patients that received HFNC oxygen therapy. Low ROX index (\< 3): Indicates a higher risk of HFNC failure. High ROX index (\> 4.88): Suggests a lower risk of HFNC failure.

Trial Locations

Locations (1)

Yale New Haven Hospital (CICU or MICU); 🇺🇸 New Haven, Connecticut, United States