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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIPPV with nasal cannula | Experimental | Non-invasive positive pressure ventilation with nasal cannula in place |
|
| NIPPV without nasal cannula | Active Comparator | Non-invasive positive pressure ventilation without nasal cannula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal cannula | Device | Placement of nasal cannula under non-invasive positive pressure ventilation mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 minutes after mask placement |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Discomfort (Verbal Numerical Rating Scale) | Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable) | After study completion (approximately 2 minutes after study start) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D April, MD, PhD, MSc | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center | San Antonio | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22050948 | Background | Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIPPV With Nasal Cannula First | Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place. Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation |
| FG001 | NIPPV Without Nasal Cannula First | Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NIPPV With Nasal Cannula First | Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place. Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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 | Posted | Median | Inter-Quartile Range | Liters per minute | 2 minutes after mask placement |
|
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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 | NIPPV With Nasal Cannula First | Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place. Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D. April | Brooke Army Medical Center | 210-916-0808 | Michael.D.April@post.harvard.edu |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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| Non-invasive positive pressure ventilation | Device | Non-invasive positive pressure ventilation |
|
|
| 20400000 | Background | Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006. |
| 3828180 | Background | Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315. |
| BG001 |
| NIPPV Without Nasal Cannula First |
Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Patient Discomfort (Verbal Numerical Rating Scale) | Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable) | Posted | Median | Inter-Quartile Range | Scores on verbal numerical rating scale | After study completion (approximately 2 minutes after study start) |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | NIPPV Without Nasal Cannula First | Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation | 0 | 32 | 0 | 32 |
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