N/A
N=47
Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation
Acute Respiratory Failure · Treatment With Noninvasive Positive Pressure Ventilation
Bottom Line
View on ClinicalTrials.gov: NCT01925534 ↗Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Jul 2024
Primary outcome: Primary: Length of Stay on Noninvasive Ventilation (NIV) — 1404; 1386 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-flow humidified nasal oxygen delivery system (Device); Standard oxygen therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay on Noninvasive Ventilation (NIV) |
1404; 1386 | — |
| SECONDARY Length of Breaks From NIV |
1345; 1221 | — |
| SECONDARY Assessment of Respiratory Rate During Break |
23.8; 21.8; 23.3; 20.1 | — |
| SECONDARY Patients' Comfort |
8.3; 6.9; 5.9; 6.2 | — |
| SECONDARY Oxygen Saturation During Breaks |
94.1; 94.7; 93.7; 95.4; 95.9; 96.4 | — |
| SECONDARY Need for Intubation |
2; 0 | — |
| SECONDARY Ease of Eating |
20; 15 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Exclusion criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01925534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.