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

Not Applicable

Recruiting

• Conditions: Intubation; Cardiovascular Surgical Procedure

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

Brief Summary

The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the all-cause 48-hour reintubation rate (extubation failure within 48 hours of initial extubation).

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 along with other therapies, including: 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.

This prospective, randomized, pragmatic clinical trial will compare HFNC to provider choice of usual 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: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Reintubation within 72 hours of extubation	72 hours	Reintubation within 72 hours of initial extubation 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
Hospital length of stay	8 days
In-hospital mortality	Until hospital discharge, which usually occurs in approximately 8 days in the majority of patients	Mortality which occurs in-hospital following surgery, up to the time of hospital discharge
Adjusted reintubation rate	48 hours	Adjusted reintubation rate within 48 hours of initial extubation, if adjustment is needed based on clinically relevant imbalance in baseline characteristics between groups
Intensive Care Unit length of stay	3 days	Intensive Care Unit length of stay after cardiac 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