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

Not Applicable

Completed

• Conditions: Pre-hospital Ventilation
• Interventions: Procedure: Hold mask; Procedure: Strap Mask; Procedure: Airway

• Registration Number: NCT01477710
• Lead Sponsor: University of Cincinnati

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.

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 Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Results First Submitted: 2013-01-23
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-11
• Last Update Submitted: 2013-03-11
• Results First Posted: 2013-03-12
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Voluntary participation
• Nurse, respiratory therapist, or physician
• involved in the care of patients requiring ventilation and airway management

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hold Mask	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.
Strap Mask	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
Airway	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.

Primary Outcome Measures

Name	Time	Method
Tidal Volume	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.

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Cincinnati, Ohio, United States