High-Flow Oxygen Therapy Following Tracheostomy

July 19, 2021 updated by: Peggy Watts, Barnes-Jewish Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mechanically ventilated patients who receive tracheostomy

Exclusion Criteria:

  • Non-English speaking and pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: High Flow High Humidity device
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)
Other Names:
  • Airvo high flow device
ACTIVE_COMPARATOR: 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.
Device: Low Flow High Humidity device
Standard high humidity trach collar utilizing venturi device bleed in
Other Names:
  • High Humidity Trach Collar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of Mechanical Ventilation (MV)
Time Frame: an average of 1 year
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
Time Frame: an average of 1 year
The number of days the subject is in the ICU
an average of 1 year
Days of hospital stay
Time Frame: an average of 1 year
Time in days from admission to hospital until discharge from hospital
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnes-Jewish Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2018

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

April 7, 2020

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (ACTUAL)

October 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201707165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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