A Phase 4 interventional study of Nasal cannula and Non-invasive positive pressure ventilation in Mechanical Ventilation Pressure High, sponsored by Brooke Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-26.
Sponsored by Brooke Army Medical Center · Phase 4, Interventional, and Treatment
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.
This is a randomized cross over study. A convenience sample of staff and resident physicians and physician assistants from the San Antonio Military Medical Center (SAMMC) Department of Emergency Medicine will be used to assess NIPPV mask seal during CPAP administration with and without nasal cannula. Volunteers will be solicited via Grand Rounds and staff meetings at San Antonio Military Medical Center. Subjects will undergo permuted block randomization by random number generator to the order of intervention, mask alone or mask with nasal cannula at 15L/min of oxygen. An emergency medicine trained physician will place equipment and operate the ventilator. After placement of the NIPPV mask and prior to each study intervention period, appropriate adjustments to enhance mask seal will be made as would happen in a therapeutic setting and the volunteer will be allowed up to two minutes to acclimate to continuous noninvasive positive pressure ventilation. Mask leak will be measured by the ventilator unit and will be recorded after 60 seconds of spontaneous restful ventilation.
Brooke Army Medical Center is the lead sponsor of 92 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-invasive positive pressure ventilation with nasal cannula in place
Device: Nasal cannula · Device: Non-invasive positive pressure ventilation
Non-invasive positive pressure ventilation without nasal cannula
Device: Non-invasive positive pressure ventilation
Placement of nasal cannula under non-invasive positive pressure ventilation mask
Also known as: NC
Non-invasive positive pressure ventilation
Also known as: NIPPV
Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine
Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine
Time frame: 2 minutes after mask placement
Patient Discomfort (Verbal Numerical Rating Scale)
Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)
Time frame: After study completion (approximately 2 minutes after study start)
| Milestone | NIPPV With Nasal Cannula First | NIPPV Without Nasal Cannula First |
|---|---|---|
| Started | 32 | 32 |
| Completed | 32 | 32 |
| Not completed | 0 | 0 |
Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine
| Liters per minute | NIPPV With Nasal Cannula | NIPPV Without Nasal Cannula |
|---|---|---|
| Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine | 0 (0 to 3.3) | 0 (0 to 0.9) |
Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)
| Scores on verbal numerical rating scale | NIPPV With Nasal Cannula | NIPPV Without Nasal Cannula |
|---|---|---|
| Patient Discomfort (Verbal Numerical Rating Scale) | 3 (2 to 5) | 1 (1 to 2) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NIPPV With Nasal Cannula First | — | 0/32 (0%) | 0/32 (0%) |
| NIPPV Without Nasal Cannula First | — | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | NIPPV With Nasal Cannula First | NIPPV Without Nasal Cannula First | Total |
|---|---|---|---|
| Median | 31 (28 to 36) | 32 (28 to 34) | 31 (28 to 35) |
| Sex: Female, Male(Participants) | NIPPV With Nasal Cannula First | NIPPV Without Nasal Cannula First | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 25 | 23 | 48 |
Plan to share: No
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brooke Army Medical Center