Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENuMask Intraoral Airway Device
NuMask Intraoral Airway Device
DEVICEBag Valve Mask
Conventional bag valve mask
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* United States Army Combat Medics
Exclusion criteria
* Injuries precluding performance of bag valve mask ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Received Minute Volume (Liters) as Measured by Wright Respirometer | 1 Minute | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | NuMask Intraoral Mask First, Then Standard Bag Valve Mask | Standard Bag Valve Mask First, Then Numask Intraoral Mask | 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 | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 013 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: 1 Minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NuMask Intraoral Airway Device | Received Minute Volume (Liters) as Measured by Wright Respirometer | 6.8 Liters |
| Bag Valve Mask | Received Minute Volume (Liters) as Measured by Wright Respirometer | 5.2 Liters |
p-value: <0.001Wilcoxon Signed Ranks