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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intubation, Cardiovascular Surgical Procedure

Intervention / Treatment
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* Other: Recommendation for high flow nasal cannula oxygen therapy order set
* Other: Provider choice standard care order set


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Nasal Canula Oxygen Therapy<br>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: Recommendation for high flow nasal cannula oxygen therapy order set<br>* 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.<br>|
| Active Comparator: Provider Choice Standard Care<br>Participants be assigned standard provider choice of standard care therapy physician order set. | Other: Provider choice standard care order set<br>* Participants will receive order set with provider choice of standard care therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation within 48 hours of extubation | Reintubation within 48 hours of initial extubation after cardiac surgery | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation within 72 hours of extubation | Reintubation within 72 hours of initial extubation after cardiac surgery | 72 hours | 
| Reintubation after cardiac surgery | Reintubation at any time during hospitalization after cardiac surgery | hospital discharge (usually 14 days) | 
| In-hospital mortality | In-hospital mortality during hospitalization after cardiac surgery | hospital discharge (usually 14 days) | 
| All cause mortality |  | 30 days post surgery | 
| Hospital length of stay |  | 8 days | 
| Intensive Care Unit length of stay | Intensive Care Unit length of stay after cardiac surgery | 3 days | 
| Ventilator-free days | Ventilator-free days during hospitalization after cardiac surgery | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-flow nasal cannula oxygen therapy, Reintubation