Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation

Completed · Not applicable

Conditions studied: Acute Respiratory Failure, Treatment With Noninvasive Positive Pressure Ventilation

In brief

The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen delivery system, is superior to standard oxygen therapy during breaks off noninvasive ventilation in patients affected by acute respiratory failure and in respiratory distress. The investigators anticipate that the Optiflow will provide oxygen more effectively, be more comfortable and permit longer breaks off NIV, shortening the total duration of NIV.

Key facts

Study ID

NCT01925534

Run by

Tufts Medical Center

People needed

47

Starts

2013-11-01

Expected to finish

2016-12-01

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of 18 or more years of age treated with Bipap or CPAP as per hospital protocol, with an underlying clinical diagnosis of acute respiratory failure.
• Patients that, prior to administration of NIV, had persistent respiratory acidosis with a pH <7.35 and arterial CO2 > 45 mmHg despite controlled oxygen therapy and standard medical management i.e. bronchodilators, corticosteroids and antibiotics, or
• Patients with hypoxemic respiratory failure with a PaO2/FiO2 ratio < 300 and respiratory rate ≥ 24.
• Anticipated duration on NIV of at least 24 hrs

You may not qualify if…

• Usual contraindications to NIV
• Respiratory arrest
• Unable to fit mask
• Medically unstable or multiple organ failure or unstable coronary disease
• Agitated or uncooperative
• Unable to protect airways
• Swallowing difficulties
• Excessive secretions not managed by clearance techniques
• Recent upper airway or gastro-intestinal surgery
• Facial deformity or previous head and neck surgery
• Undrained pneumothorax
• NIV failure within first 2 hours (either intolerance or requirement for intubation)
• Managed for greater than 48 hours on NIV prior to randomization
• Disorientation, confusion, unable to rate comfort or dyspnea
• Expected to require NIV for fewer than 24 hrs from the time of enrollment
• Patient previously in study
• Patients on CPAP nighttime only due to OSA
• Withdrawal/Termination criteria:
• Patients will be withdrawn from the study when NIV fails and/or the patient is intubated.

Where it is running

• Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center — Boston, Massachusetts, United States
• Intensive Care Unit, Winchester Hospital — Winchester, Massachusetts, United States

Full record on ClinicalTrials.gov

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