High-Flow Oxygen Therapy Following Tracheostomy

Study Overview
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Brief Summary
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Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. There are two major ways of administering oxygen to patients which include low flow delivered at less than 10Liters per minute (LPM) and high-flow delivered at greater than 10LPM. There is not a currently accepted standard of care practice for how to administer oxygen therapy to these patients. Both Low and High Flow are accepted practices in the US.

Detailed Description
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Many patients with Respiratory Failure undergo tracheostomy due to difficulty weaning from mechanical ventilation. A component of weaning a patient with tracheostomy usually involves the administration of oxygen via High Humidity device. There are two major ways of administering oxygen via High Humidity to patients. They include low flow high humidity; delivered at less than or equal to 10LPM or high-flow humidity, delivered at greater than 10LPM. There is not a currently accepted standard of practice for how to administer oxygen high humidity to patients who receive a tracheostomy due to respiratory failure. Both Low and High Flow high humidity devices are used routinely by health care facilities nationwide. Therefore, the investigators plan to perform a crossover study in both a medicine and surgical Intensive Care Unit to determine which type of oxygen High Humidity therapy should be preferentially utilized. Patients in one Intensive Care Unit will start off with Low Flow high humidity while the alternate unit will start with Hi Flow high humidity. After one half of the required sample size is accrued the investigators will cross over the two ICUs to the alternate type of oxygen High Humidity device. No other respiratory practices will change during the conduct of this trial.

Official Title
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Low-Flow (LF) Oxygen Versus Heated Humidified High-Flow (HF) Therapy Following Tracheostomy

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: High Flow High Humidity device
* Device: Low Flow High Humidity device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated patients who receive tracheostomy Exclusion Criteria: Non-English speaking and pregnancy

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Crossover study between 2 medical ICUs and 1 Surgical ICU. Patients in one unit will start off with Low Flow (LF) while the other unit will start off with High Flow (HF). After one half of the required sample size is accrued we will crossover the Medicine ICUs with the Surgical ICU.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow High Humidity device<br>High Flow High Humidity device arm subjects will be placed on a High Flow Airvo device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. This device has its own flow generator built in. | Device: High Flow High Humidity device<br>* High Flow High Humidity device has a flow generator built into the body of unit and can deliver flows between 10 to 60 Liters per minute (LPM) with oxygen bled in as needed in order to deliver specified Fraction of inspired Oxygen (FiO2)<br>* Other names: Airvo high flow device;|
| Active Comparator: Low Flow High Humidity Device<br>Low Flow High Humidity device arm patients will be placed on a Low Flow device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. | Device: Low Flow High Humidity device<br>* Standard high humidity trach collar utilizing venturi device bleed in<br>* Other names: High Humidity Trach Collar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Mechanical Ventilation (MV) | Time in days from initiation of MV until discontinuance of MV | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of ICU Stay | The number of days the subject is in the ICU | an average of 1 year | 
| Days of hospital stay | Time in days from admission to hospital until discharge from hospital | an average of 1 year |