Clinical trial NCT04782817: Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
Official title: Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation
Cardiovascular Surgical Procedure
Keywords: High-flow nasal cannula oxygen therapy
Reintubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-03-04
Enrollment: 3192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reintubation within 48 hours of extubation
timeFrame: 48 hours
Secondary outcomes:
measure: Reintubation within 72 hours of extubation
timeFrame: 72 hours
measure: Reintubation after cardiac surgery
timeFrame: hospital discharge (usually 14 days)
measure: In-hospital mortality
timeFrame: hospital discharge (usually 14 days)
measure: All cause mortality
timeFrame: 30 days post surgery
measure: Hospital length of stay
timeFrame: 8 days
measure: Intensive Care Unit length of stay
timeFrame: 3 days
measure: Ventilator-free days
timeFrame: 1 day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Robert E Freundlich, MD
role: PRINCIPAL_INVESTIGATOR
References:
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