NCT03721419

High-Flow Oxygen Therapy Following Tracheostomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Barnes-Jewish Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
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)
DEVICE	Low Flow High Humidity device	Standard high humidity trach collar utilizing venturi device bleed in

Timeline

• Start date: 2018-05-17
• Primary completion: 2020-03-30
• Completion: 2020-04-07
• First posted: 2018-10-26
• Last updated: 2021-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study