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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014