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

Launched by YALE UNIVERSITY · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare two types of breathing support methods for patients with systolic heart failure, which is a condition that affects the heart's ability to pump blood effectively. Specifically, the trial will enroll patients who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours and have a weakened heart function (an ejection fraction of 40% or less). Participants will be randomly assigned to receive either high-flow nasal cannula (a device that delivers oxygen through the nose) or non-invasive ventilation (a mask that helps with breathing) after they are taken off the breathing machine.

To be eligible for this trial, participants must be adults aged 18 or older, and they can't have certain conditions like chronic obstructive pulmonary disease (COPD) or other factors that would make them unsuitable for the study, such as being uncooperative or having a do-not-resuscitate order. If someone decides to participate, they will be informed about the study and must provide consent. The trial is not yet recruiting participants, so there will be no immediate changes for patients, but it aims to find out which method might help prevent the need for reintubation (going back on the breathing machine) and improve recovery in these high-risk patients.

Gender

ALL

Eligibility criteria

• 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).
• 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)