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Clinical Trials/NCT03721419
NCT03721419
Completed
Not Applicable

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

Barnes-Jewish Hospital1 site in 1 country61 target enrollmentMay 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
Barnes-Jewish Hospital
Enrollment
61
Locations
1
Primary Endpoint
Days of Mechanical Ventilation (MV)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2018
End Date
April 7, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peggy Watts

Manager, Respiratory Therapy

Barnes-Jewish Hospital

Eligibility Criteria

Inclusion Criteria

  • Mechanically ventilated patients who receive tracheostomy

Exclusion Criteria

  • Non-English speaking and pregnancy

Outcomes

Primary Outcomes

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

  • Days of ICU Stay(an average of 1 year)
  • Days of hospital stay(an average of 1 year)

Study Sites (1)

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