Pre-hospital Ventilation
Conditions
Keywords
Mechanical ventilation, Tidal volume, Respiratory rate
Brief summary
This study will compare three methods of delivering mechanical ventilation using a test lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints include respiratory rate and tidal volume.
Detailed description
To evaluate the ability of caregivers to provide adequate ventilation (respiratory rate and tidal volume) in a model of the upper airway and lungs. Ventilation will be delivered while the mask is held in place by the caregiver, with the mask strapped to the model using the securing device provided with the ventilator, and following placement of a supraglottic airway.
Interventions
PROCEDUREHold mask
The clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes.
PROCEDUREStrap Mask
The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes
PROCEDUREAirway
The clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
Sponsors
United States Air Force
University of Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Voluntary participation * Nurse, respiratory therapist, or physician * involved in the care of patients requiring ventilation and airway management
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tidal Volume | 10 minutes per technique, for a total of 30 minutes per participant | Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded. |
Countries
United States
Participant flow
Recruitment details
Subjects (registered nurses, respiratory therapists, and physicians) volunteered to participate and signed informed consent documents.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Each clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Then, each will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, each will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 36.9 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Tidal Volume
Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.
Time frame: 10 minutes per technique, for a total of 30 minutes per participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hold Mask | Tidal Volume | 341.8 milliliters (mL) | Standard Error 17.7 |
| Strap Mask | Tidal Volume | 27.5 milliliters (mL) | Standard Error 17.7 |
| Airway | Tidal Volume | 604.1 milliliters (mL) | Standard Error 17.7 |
Comparison: Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.p-value: <0.0001ANOVA
p-value: <0.000195% CI: [264.7, 364.1]t-test, 2 sided
p-value: <0.000195% CI: [526.9, 626.3]t-test, 2 sided
p-value: <0.000195% CI: [212.5, 312]t-test, 2 sided