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High-Flow Oxygen Therapy Following Tracheostomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03721419
Enrollment
61
Registered
2018-10-26
Start date
2018-05-17
Completion date
2020-04-07
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

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.

Interventions

DEVICEHigh 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)

DEVICELow Flow High Humidity device

Standard high humidity trach collar utilizing venturi device bleed in

Sponsors

Barnes-Jewish Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single blind

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Mechanically ventilated patients who receive tracheostomy

Exclusion criteria

* Non-English speaking and pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Days of Mechanical Ventilation (MV)an average of 1 yearTime in days from initiation of MV until discontinuance of MV

Secondary

MeasureTime frameDescription
Days of ICU Stayan average of 1 yearThe number of days the subject is in the ICU
Days of hospital stayan average of 1 yearTime in days from admission to hospital until discharge from hospital

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026