An interventional study of Ventilation with nasal cannula and Ventilation without nasal cannula in Hypoxia, sponsored by Brooke Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Brooke Army Medical Center · Not applicable, Interventional, and Prevention
This is a prospective randomized cross over study of healthy volunteers comparing end-tidal oxygen concentration among subjects undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas.
Noninvasive positive pressure ventilation with the addition of a nasal cannula is a useful technique to pre-oxygenate and provide apneic oxygenation in hypoxic patients undergoing emergency airway management. This study aims to evaluate preoxygenation by quantifying end-tidal oxygen (etO2) concentration resulting from nasal cannula placement underneath a noninvasive positive pressure ventilation (NIPPV) mask. 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. End-tidal oxygen concentration will be measured by an oxygen sensor following three minutes of NIPPV with and without the addition of a nasal cannula, with each subject serving as his or her own control.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 37 is below the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →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.
Device: Ventilation with nasal cannula · Device: Ventilation without nasal cannula
Non-invasive positive pressure ventilation without nasal cannula.
Device: Ventilation with nasal cannula · Device: Ventilation without nasal cannula
Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
End-tidal Oxygen
Measured by exhalation into sensor (Maxtec Max-250E)
Time frame: 3 minutes after study start
| Milestone | Ventilation With Nasal Cannula First, Then Without Nasal Cannula | Ventilation Without Nasal Cannula First, Then With Nasal Cannula |
|---|---|---|
| Started | 18 | 19 |
| Completed | 18 | 19 |
| Not completed | 0 | 0 |
| Milestone | Ventilation With Nasal Cannula First, Then Without Nasal Cannula | Ventilation Without Nasal Cannula First, Then With Nasal Cannula |
|---|---|---|
| Started | 18 | 19 |
| Completed | 18 | 19 |
| Not completed | 0 | 0 |
| Milestone | Ventilation With Nasal Cannula First, Then Without Nasal Cannula | Ventilation Without Nasal Cannula First, Then With Nasal Cannula |
|---|---|---|
| Started | 18 | 19 |
| Completed | 18 | 19 |
| Not completed | 0 | 0 |
Measured by exhalation into sensor (Maxtec Max-250E)
| End tidal oxygen saturation percentage | Ventilation With Nasal Cannula | Ventilation Without Nasal Cannula |
|---|---|---|
| End-tidal Oxygen | 78.1 (75.5 to 80.8) | 78.6 (75.6 to 81.4) |
Collected over Study duration (approximately 30 minutes).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ventilation With Nasal Cannula | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Ventilation Without Nasal Cannula | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Ventilation With Nasal Cannula First | Ventilation Without Nasal Cannula First | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 19 | 37 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ventilation With Nasal Cannula First | Ventilation Without Nasal Cannula First | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 13 | 13 | 26 |
| Race and Ethnicity Not Collected(Participants) | Ventilation With Nasal Cannula First | Ventilation Without Nasal Cannula First | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Ventilation With Nasal Cannula First | Ventilation Without Nasal Cannula First | Total |
|---|---|---|---|
| United States | 18 | 19 | 37 |
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Brooke Army Medical Center