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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventilation with nasal cannula | Experimental | Non-invasive positive pressure ventilation with nasal cannula. |
|
| Ventilation without nasal cannula | Active Comparator | Non-invasive positive pressure ventilation without nasal cannula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilation with nasal cannula | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal Oxygen | Measured by exhalation into sensor (Maxtec Max-250E) | 3 minutes after study start |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek J Brown, MD | United States Army Institute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16627862 | Background | Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20. | |
| 26836712 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ventilation With Nasal Cannula First, Then Without Nasal Cannula | First intervention: 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). Second intervention: 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). |
| FG001 | Ventilation Without Nasal Cannula First, Then With Nasal Cannula | First intervention: 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). Second intervention: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Minutes) |
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| Washout Period (5 Minutes) |
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| Second Intervention (3 Minutes) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | End-tidal Oxygen | Measured by exhalation into sensor (Maxtec Max-250E) | 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. | Posted | Mean | 95% Confidence Interval | End tidal oxygen saturation percentage | 3 minutes after study start |
|
Study duration (approximately 30 minutes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ventilation With Nasal Cannula | Subject is fitted with a face mask and undergoes 3 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 exhales into an oxygen sensor (Maxtec Max-250E). The cross over design means all patients eventually underwent both ventilation with nasal cannula and ventilation without nasal cannula, accounting for any combining of patients in analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Derek Brown | Brooke Army Medical Center | 2109160808 | Derek.J.Brown1.mil@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2017 | Jul 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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| Ventilation without nasal cannula | Device | 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). |
|
| Sakles JC, Mosier JM, Patanwala AE, Arcaris B, Dicken JM. First Pass Success Without Hypoxemia Is Increased With the Use of Apneic Oxygenation During Rapid Sequence Intubation in the Emergency Department. Acad Emerg Med. 2016 Jun;23(6):703-10. doi: 10.1111/acem.12931. Epub 2016 May 13. |
| 26164643 | Background | Bodily JB, Webb HR, Weiss SJ, Braude DA. Incidence and Duration of Continuously Measured Oxygen Desaturation During Emergency Department Intubation. Ann Emerg Med. 2016 Mar;67(3):389-95. doi: 10.1016/j.annemergmed.2015.06.006. Epub 2015 Jul 9. |
| 26747218 | Background | Hayes-Bradley C, Lewis A, Burns B, Miller M. Efficacy of Nasal Cannula Oxygen as a Preoxygenation Adjunct in Emergency Airway Management. Ann Emerg Med. 2016 Aug;68(2):174-80. doi: 10.1016/j.annemergmed.2015.11.012. Epub 2015 Dec 31. |
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| NOT COMPLETED |
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| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
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|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Ventilation Without Nasal Cannula | Subject is fitted with a face mask and undergoes 3 continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and exhales into an oxygen sensor (Maxtec Max-250E). The cross over design means all patients eventually underwent both ventilation with nasal cannula and ventilation without nasal cannula, accounting for any combining of patients in analysis. | 0 | 37 | 0 | 37 | 0 | 37 |
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