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

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Cardiovascular Surgical Procedure; Intubation

Treatments: Other: Provider choice standard care order set; Other: Recommendation for high flow nasal cannula oxygen therapy order set

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04782817

181117

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age ≥18 years
• Undergoing cardiac surgery, defined as a documented surgical service of "cardiac surgery" in the electronic health record, performed in the main operating rooms at Vanderbilt University Medical Center
• Admitted to the cardiovascular intensive care unit postoperatively with an endotracheal tube in place and mechanically ventilated
• Surgery duration (documented time between "Anesthesia start" and "Anesthesia stop" in the EHR) of at least 180 minutes
• Received an order to be extubated by a treating provider o Patients who meet all other criteria but do not receive an order to extubate will be randomized but not enrolled

Exclusion Criteria

• Patient does not meet inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,400 participants in 2 patient groups

High Flow Nasal Canula Oxygen Therapy

Experimental group

Description:

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.

Treatment:

Other: Recommendation for high flow nasal cannula oxygen therapy order set

Provider Choice Standard Care

Active Comparator group

Description:

Participants be assigned standard provider choice of standard care therapy physician order set.

Treatment:

Other: Provider choice standard care order set