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This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat medics.
This study comprised a randomized crossover trial of adult United States Army combat medic volunteers participating in a cadaver laboratory as part of their training. The study took place in Bulverde, TX. Participants were randomized to perform cadaver ventilation first using either the novel Nu-MaskR intraoral device or conventional bag valve mask. A one handed seal technique was used to simulate single operator ventilation. Participants were responsible for mask placement while a ventilator delivered 10 breaths each with a standardized tidal volume of 750 ml. After a 5-minute washout period, they performed ventilation using the alternative device. The primary outcome measure was air leak as calculated by subtracting tidal volume received from tidal volume delivered as measured by the ventilator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuMask Intraoral Airway Device | Experimental | A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. |
|
| Bag Valve Mask | Active Comparator | A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuMask Intraoral Airway Device | Device | NuMask Intraoral Airway Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Received Minute Volume (Liters) as Measured by Wright Respirometer | An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths. | 1 Minute |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | NuMask Intraoral Mask First, Then Standard Bag Valve Mask | A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask. NuMask Intraoral Airway Device: NuMask Intraoral Airway Device |
| FG001 | Standard Bag Valve Mask First, Then Numask Intraoral Mask | A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask. Bag Valve Mask: Conventional bag valve mask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NuMask Intraoral Mask First, Then Standard Bag Valve Mask | A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a standard bag valve mask. NuMask Intraoral Airway Device: NuMask Intraoral Airway Device |
| 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 | Received Minute Volume (Liters) as Measured by Wright Respirometer | An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths. | Posted | Median | Inter-Quartile Range | Liters | 1 Minute |
|
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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 | NuMask Intraoral Airway Device | A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. NuMask Intraoral Airway Device: NuMask Intraoral Airway Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D. April | San Antonio Military Medical Center | (210) 916-0808 | Michael.D.April@post.harvard.edu |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Bag Valve Mask |
| Device |
Conventional bag valve mask |
|
| BG001 | Standard Bag Valve Mask First, Then Numask Intraoral Mask | A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device. Bag Valve Mask: Conventional bag valve mask |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bag Valve Mask |
A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. Bag Valve Mask: Conventional bag valve mask |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Bag Valve Mask | A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. Bag Valve Mask: Conventional bag valve mask | 0 | 27 | 0 | 27 |
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| D013568 | Pathological Conditions, Signs and Symptoms |