Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
United States Air Force
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01477710
First received: November 18, 2011
Last updated: March 11, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pre-hospital Ventilation |
Procedure: Hold mask Procedure: Strap Mask Procedure: Airway |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- Tidal Volume [ Time Frame: 10 minutes per technique, for a total of 30 minutes per participant ] [ Designated as safety issue: No ]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.
| Enrollment: | 30 |
| Study Start Date: | May 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Hold 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.
|
Procedure: Hold 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.
|
|
Active Comparator: Strap 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
|
Procedure: Strap 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
|
|
Active Comparator: Airway
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.
|
Procedure: Airway
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.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Voluntary participation
- Nurse, respiratory therapist, or physician
- involved in the care of patients requiring ventilation and airway management
Exclusion Criteria:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477710
Locations
| United States, Ohio | |
| University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
Sponsors and Collaborators
University of Cincinnati
United States Air Force
Investigators
| Principal Investigator: | Richard D Branson, MSc RRT | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01477710 History of Changes |
| Other Study ID Numbers: | Branson-2010-01 |
| Study First Received: | November 18, 2011 |
| Results First Received: | January 23, 2013 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Cincinnati:
|
Mechanical ventilation Tidal volume Respiratory rate |
ClinicalTrials.gov processed this record on June 13, 2013