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Completed

NCT Number: NCT04782817

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recommendation for high flow nasal cannula oxygen therapy order set

Other

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 order set

Other

Participants will receive order set with provider choice of standard care therapy.

Primary outcomes

  1. Reintubation within 48 hours of extubation

    Time frame: 48 hours

    Reintubation within 48 hours of initial extubation after cardiac surgery

Secondary outcomes

  1. Reintubation within 72 hours of extubation

    Time frame: 72 hours

    Reintubation within 72 hours of initial extubation after cardiac surgery

  2. Reintubation after cardiac surgery

    Time frame: hospital discharge (usually 14 days)

    Reintubation at any time during hospitalization after cardiac surgery

  3. All cause mortality

    Time frame: 30 days post surgery

  4. Hospital length of stay

    Time frame: 8 days

  5. Intensive Care Unit length of stay

    Time frame: 3 days

    Intensive Care Unit length of stay after cardiac surgery

  6. Ventilator-free days

    Time frame: 1 day

    Ventilator-free days during hospitalization after cardiac surgery

  7. In-hospital mortality

    Time frame: 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

  8. Adjusted reintubation rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2021
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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