Trial Outcomes & Findings for Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model (NCT NCT01477710)
NCT ID: NCT01477710
Last Updated: 2024-09-20
Results Overview
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.
COMPLETED
NA
30 participants
10 minutes per technique, for a total of 30 minutes per participant
2024-09-20
Participant Flow
Subjects (registered nurses, respiratory therapists, and physicians) volunteered to participate and signed informed consent documents.
Participant milestones
| Measure |
All Participants
Each participant will perform 3 tasks -- in the same order. First, 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. Next, the clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, 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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model
Baseline characteristics by cohort
| Measure |
All Participants
n=30 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes per technique, for a total of 30 minutes per participantNurses, 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.
Outcome measures
| Measure |
Hold Mask
n=30 Participants
Mask is held in place by caregiver.
|
Strap Mask
n=30 Participants
Mask is strapped to model using a securing device
|
Airway
n=30 Participants
Using a supraglottic airway
|
|---|---|---|---|
|
Tidal Volume
|
341.8 milliliters (mL)
Standard Error 17.7
|
27.5 milliliters (mL)
Standard Error 17.7
|
604.1 milliliters (mL)
Standard Error 17.7
|
Adverse Events
Hold Mask
Strap Mask
Airway
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place