Hypoxia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVentilation with 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).
DEVICEVentilation 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). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Any healthy volunteer aged 18-65 years.
Exclusion criteria
* Previous inability to tolerate noninvasive positive pressure ventilation with addition of a nasal cannula. * Known underlying cardiac or pulmonary disease. * Active respiratory infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End-tidal Oxygen | 3 minutes after study start | Measured by exhalation into sensor (Maxtec Max-250E) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventilation With Nasal Cannula First Non-invasive positive pressure ventilation with nasal cannula first followed by non-invasive positive pressure ventilation without nasal cannula.
Ventilation with 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).
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). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E). | 18 |
| Ventilation Without Nasal Cannula First Non-invasive positive pressure ventilation without nasal cannula first followed by non-invasive positive pressure ventilation with nasal cannula.
Ventilation with 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).
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). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E). | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | Ventilation Without Nasal Cannula First | Total | Ventilation With Nasal Cannula First |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 37 Participants | 18 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 19 participants | 37 participants | 18 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
End-tidal Oxygen
Measured by exhalation into sensor (Maxtec Max-250E)
Time frame: 3 minutes after study start
Population: This was a cross-over study so ultimately all patients underwent both ventilation with nasal cannula and ventilation without nasal cannula; 18 underwent ventilation with nasal cannula first whereas the remaining 19 participants underwent ventilation without nasal cannula first. This design accounts for any combining of patients in analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ventilation With Nasal Cannula | End-tidal Oxygen | 78.1 End tidal oxygen saturation percentage |
| Ventilation Without Nasal Cannula | End-tidal Oxygen | 78.6 End tidal oxygen saturation percentage |