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Completed

NCT Number: NCT03721419

High-Flow Oxygen 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mechanically ventilated patients who receive tracheostomy

Exclusion criteria

  • Non-English speaking and pregnancy

Treatment and study plan

High Flow High Humidity device

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

Low Flow High Humidity device

Device

Standard high humidity trach collar utilizing venturi device bleed in

Other names: High Humidity Trach Collar

Primary outcomes

  1. Days of Mechanical Ventilation (MV)

    Time frame: an average of 1 year

    Time in days from initiation of MV until discontinuance of MV

Secondary outcomes

  1. Days of ICU Stay

    Time frame: an average of 1 year

    The number of days the subject is in the ICU

  2. Days of hospital stay

    Time frame: an average of 1 year

    Time in days from admission to hospital until discharge from hospital

Sponsors and collaborators

Lead sponsor

Barnes-Jewish Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2018
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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