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

• ClinicalTrials.gov Identifier: NCT01477710
• Recruitment Status: Completed
• First Posted: November 22, 2011
• Results First Posted: March 12, 2013
• Last Update Posted: March 12, 2013
• Sponsor: University of Cincinnati
• Collaborator: United States Air Force
• Information provided by (Responsible Party): University of Cincinnati

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pre-hospital Ventilation	Procedure: Hold mask; Procedure: Strap Mask; Procedure: Airway	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• 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
• Study Start Date: May 2011
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: Branson-2010-01
• First Posted: November 22, 2011
• 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