Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula

Not Applicable

Recruiting

• Conditions: Intubation; Cardiovascular Surgical Procedure
• Interventions: Other: Recommendation for high flow nasal cannula oxygen therapy order set; Other: Provider choice standard care order set

• Registration Number: NCT04782817
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

The purpose of this study is to compare reintubation rates and outcomes of patients treated with high-flow nasal canula oxygen therapy (HFNC) and patients treated with provider choice of standard care.

Detailed Description

HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit and is selectively employed in patients who are judged by the provider to be high-risk, along with other therapies: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population.

To guide a future, larger, multicenter randomized controlled pragmatic clinical trial, a pilot study in a single, high-volume cardiovascular intensive care unit will be performed. The prospective, randomized, pragmatic pilot clinical trial will compare HFNC to provider choice of standard care in these high-risk patients.

Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge.

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3192

Inclusion Criteria

• Adults aged 18 and over treated in the Vanderbilt Cardiovascular Intensive Care Unit following cardiac surgery (defined as surgery on the heart or thoracic aorta, excluding percutaneous procedures)
• Surgical duration (anesthesia start to anesthesia stop) of at least 3 hours.
• Intubated at the time of arrival in the Cardiovascular Intensive Care Unit
• Extubated to occur at some point following arrival in the Cardiovascular Intensive Care Unit with an order to extubate the patient by a treating provider.

Exclusion Criteria

• Does not meet inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Canula Oxygen Therapy	Recommendation for high flow nasal cannula oxygen therapy order set	Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.
Provider Choice Standard Care	Provider choice standard care order set	Participants be assigned standard provider choice of standard care therapy physician order set.

Primary Outcome Measures

Name	Time	Method
Reintubation within 48 hours of extubation	48 hours	Reintubation within 48 hours of initial extubation after cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	8 days
Intensive Care Unit length of stay	3 days	Intensive Care Unit length of stay after cardiac surgery
Reintubation within 72 hours of extubation	72 hours	Reintubation within 72 hours of initial extubation after cardiac surgery
In-hospital mortality	hospital discharge (usually 14 days)	In-hospital mortality during hospitalization after cardiac surgery
Reintubation after cardiac surgery	hospital discharge (usually 14 days)	Reintubation at any time during hospitalization after cardiac surgery
All cause mortality	30 days post surgery
Ventilator-free days	1 day	Ventilator-free days during hospitalization after cardiac surgery

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States