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Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with a supplemental external 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. The modified device comprised a standard bag valve mask with supplemental external bar. Data was collected during May 2016 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 mask first | 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). Volunteer then repeats the procedures using a conventional Ambu Spur II bag valve mask. |
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| Conventional Ambu Spur II bag mask first | 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). Volunteer then repeats the procedures using a modified Ambu Spur II bag valve mask. |
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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 a supplemental external handle |
| Measure | Description | Time Frame |
|---|---|---|
| Received Tidal Volume | Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output. | 3 minutes |
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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 |
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| 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 Then Conventional Ambu Spur II Bag Valve Mask | 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). Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle. After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask. |
| FG001 | Conventional Then Modified Ambu Spur II Bag Valve Mask | 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). Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Then Conventional Ambu Spur II Bag Valve Mask | 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). Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle. After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask. |
| 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 Tidal Volume | Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output. | Posted | Mean | 95% Confidence Interval | milliliters | 3 minutes |
|
1 hour
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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 Spur II Bag Valve Mask | 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). Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle. After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D. April | San Antonio Uniformed Services Health Education Consortium | 2109160808 | 210 | 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 |
|
| 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. |
| NOT COMPLETED |
|
| BG001 | Conventional Then Modified Ambu Spur II Bag Valve Mask | 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). Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask. After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Conventional Bag Valve Mask |
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). Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask. After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask. |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Conventional Ambu Spur II Bag Valve Mask | 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). Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask. After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask. | 0 | 70 | 0 | 70 |
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| D013568 | Pathological Conditions, Signs and Symptoms |