NCT04782817

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,568 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intubation
• Cardiovascular Surgical Procedure

Interventions

Type	Name	Description
OTHER	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.
OTHER	Provider choice standard care order set	Participants will receive order set with provider choice of standard care therapy.

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-11-19
• Completion: 2026-03-01
• First posted: 2021-03-04
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States