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| Name | Class |
|---|---|
| United States Air Force | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hold Mask | Active Comparator | 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. |
|
| Strap Mask | Active Comparator | The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes |
|
| Airway | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hold mask | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes per technique, for a total of 30 minutes per participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Branson, MSc RRT | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Cincinnati | Ohio | 45219 | United States |
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Subjects (registered nurses, respiratory therapists, and physicians) volunteered to participate and signed informed consent documents.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | Posted | Mean | Standard Error | milliliters (mL) | 10 minutes per technique, for a total of 30 minutes per participant |
|
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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 | Hold Mask |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Branson | University of Cincinnati | 513-558-6785 | bransonrd@uc.edu |
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| Strap Mask | Procedure | The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes |
|
| Airway | Procedure | 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. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Airway | Using a supraglottic airway |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Strap Mask | 0 | 30 | 0 | 30 |
| EG002 | Airway | 0 | 30 | 0 | 30 |
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