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Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477710
First Posted: November 22, 2011
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Air Force
Information provided by (Responsible Party):
University of Cincinnati
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01477710     History of Changes
Other Study ID Numbers: Branson-2010-01
First Submitted: November 18, 2011
First Posted: November 22, 2011
Results First Submitted: January 23, 2013
Results First Posted: March 12, 2013
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by University of Cincinnati:
Mechanical ventilation
Tidal volume
Respiratory rate