High-Flow Oxygen Therapy Following Tracheostomy

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Device: Low Flow High Humidity device; Device: High Flow High Humidity device

• Registration Number: NCT03721419
• Lead Sponsor: Barnes-Jewish Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-29
• Study Start: 2018-05-17
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Status Verified: 2019-07
• Primary Completion: 2020-03-30
• Study Completion: 2020-04-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Mechanically ventilated patients who receive tracheostomy

Exclusion Criteria

• Non-English speaking and pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Flow High Humidity Device	Low Flow High Humidity device	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.
High Flow High Humidity device	High Flow High Humidity device	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.

Primary Outcome Measures

Name	Time	Method
Days of Mechanical Ventilation (MV)	an average of 1 year	Time in days from initiation of MV until discontinuance of MV

Secondary Outcome Measures

Name	Time	Method
Days of ICU Stay	an average of 1 year	The number of days the subject is in the ICU
Days of hospital stay	an average of 1 year	Time in days from admission to hospital until discharge from hospital

Trial Locations

Locations (1)

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States