Phase 4
N=64
Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation
Mechanical Ventilation Pressure High
Bottom Line
View on ClinicalTrials.gov: NCT02743936 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine — 0; 0 Liters per minute
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nasal cannula (Device); Non-invasive positive pressure ventilation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brooke Army Medical Center
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine |
0; 0 | — |
| SECONDARY Patient Discomfort (Verbal Numerical Rating Scale) |
3; 1 | — |
Summary
This is a prospective randomized cross over study of healthy volunteers undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as his or her own control.
Eligibility Criteria
Inclusion Criteria
- 18 years of age
- Volunteer for study
Exclusion Criteria
- Known cardiac disease
- Known pulmonary disease (to include respiratory infections)
Data sourced from ClinicalTrials.gov (NCT02743936). 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.