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Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model.
This was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (BVM) device in a manikin airway model. Data was collected from July 2015 through October 2015 at the San Antonio Military Medical Center. Emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. Prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with BVM ventilation. Hand grip strength and size (length, width, span) were measured. Each participant was then asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters. After a 3 minute rest period, testing was repeated with the second device. After ventilation with each device, participants completed an anonymous questionnaire that used a Likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. Each participant served as his/her own control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Ambu Spur II bag valve mask | Experimental | A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). |
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| Conventional Ambu Spur II bag valve mask | Active Comparator | A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Ambu Spur II bag valve mask | Device | Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Received Tidal Volume | Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Bag Valve Mask (BVM) Ease of Use | Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5). | Within 10 minutes of study completion |
| Modified Bag Valve Mask (BVM) Better Seal Formation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D April, MD, DPhil | Brooke Army Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center | San Antonio | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15988424 | Background | Davidovic L, LaCovey D, Pitetti RD. Comparison of 1- versus 2-person bag-valve-mask techniques for manikin ventilation of infants and children. Ann Emerg Med. 2005 Jul;46(1):37-42. doi: 10.1016/j.annemergmed.2005.02.005. | |
| 24841402 | Background | Braude DA, Tawil I, Gerstein NS, Carey MC, Petersen TR. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jun;63(6):784-5. doi: 10.1016/j.annemergmed.2014.01.037. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM | A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask. |
| FG001 | Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM | A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM | A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Received Tidal Volume | Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters | Posted | Mean | Standard Deviation | milliliters | 3 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 | Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM | A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask. |
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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 |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Conventional Ambu Spur II bag valve mask | Device | Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask |
|
Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation). |
| Within 10 minutes of study completion |
| Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation | Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use). | Within 10 minutes of study completion |
| Number of Participants Who Preferred the Modified Bag Valve Mask (BVM) | Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM. | Within 10 minutes of study completion |
| 23937957 | Background | Otten D, Liao MM, Wolken R, Douglas IS, Mishra R, Kao A, Barrett W, Drasler E, Byyny RL, Haukoos JS. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jan;63(1):6-12.e3. doi: 10.1016/j.annemergmed.2013.07.014. Epub 2013 Aug 9. |
| 27238825 | Background | Amack AJ, Barber GA, Ng PC, Smith TB, April MD. Comparison of Ventilation With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed Face Mask in a Cadaver Model: A Randomized Crossover Trial. Ann Emerg Med. 2017 Jan;69(1):12-17. doi: 10.1016/j.annemergmed.2016.04.017. Epub 2016 May 27. |
| BG001 | Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM | A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Modified Bag Valve Mask (BVM) Ease of Use | Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5). | Posted | Median | Inter-Quartile Range | Units on a scale | Within 10 minutes of study completion |
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| Secondary | Modified Bag Valve Mask (BVM) Better Seal Formation | Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation). | Posted | Median | Inter-Quartile Range | Units on a scale | Within 10 minutes of study completion |
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| Secondary | Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation | Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use). | Posted | Median | Inter-Quartile Range | Units on a scale | Within 10 minutes of study completion |
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| Secondary | Number of Participants Who Preferred the Modified Bag Valve Mask (BVM) | Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM. | Posted | Number | participants | Within 10 minutes of study completion |
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| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM | A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle. | 0 | 35 | 0 | 35 |
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| D013568 | Pathological Conditions, Signs and Symptoms |