Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Emergency Department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists.
Exclusion criteria
* Not trained in basic life support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Received Tidal Volume | 3 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Bag Valve Mask (BVM) Ease of Use | Within 10 minutes of study completion | 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). |
| Modified Bag Valve Mask (BVM) Better Seal Formation | Within 10 minutes of study completion | 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). |
| Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation | Within 10 minutes of study completion | 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). |
| Number of Participants Who Preferred the Modified Bag Valve Mask (BVM) | Within 10 minutes of study completion | Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM | Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 70 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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
Time frame: 3 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Ambu Spur II Bag Valve Mask | Mean Received Tidal Volume | 681 milliliters | Standard Deviation 148 |
| Conventional Ambu Spur II Bag Valve Mask | Mean Received Tidal Volume | 591 milliliters | Standard Deviation 142 |
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).
Time frame: Within 10 minutes of study completion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Modified Ambu Spur II Bag Valve Mask | Modified Bag Valve Mask (BVM) Better Seal Formation | 4 Units on a scale |
| Conventional Ambu Spur II Bag Valve Mask | Modified Bag Valve Mask (BVM) Better Seal Formation | 4 Units on a scale |
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).
Time frame: Within 10 minutes of study completion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Modified Ambu Spur II Bag Valve Mask | Modified Bag Valve Mask (BVM) Ease of Use | 5 Units on a scale |
| Conventional Ambu Spur II Bag Valve Mask | Modified Bag Valve Mask (BVM) Ease of Use | 5 Units on a scale |
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).
Time frame: Within 10 minutes of study completion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Modified Ambu Spur II Bag Valve Mask | Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation | 5 Units on a scale |
| Conventional Ambu Spur II Bag Valve Mask | Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation | 5 Units on a scale |
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.
Time frame: Within 10 minutes of study completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Ambu Spur II Bag Valve Mask | Number of Participants Who Preferred the Modified Bag Valve Mask (BVM) | 28 participants |
| Conventional Ambu Spur II Bag Valve Mask | Number of Participants Who Preferred the Modified Bag Valve Mask (BVM) | 28 participants |