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

NCT01477710 | Completed Results

• 1 other identifier: Branson-2010-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-hospital Ventilation

Keywords

Mechanical ventilation; Tidal volume; Respiratory rate

Outcome Measures

Primary Outcomes (1)

• Tidal Volume

  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.

  10 minutes per technique, for a total of 30 minutes per participant

Study Arms (3)

Hold Mask

ACTIVE COMPARATOR

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

Strap Mask

ACTIVE COMPARATOR

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

Airway

ACTIVE COMPARATOR

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

Interventions

Hold mask PROCEDURE

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.

Hold Mask

Strap Mask PROCEDURE

The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes

Strap Mask

Airway PROCEDURE

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.

Airway

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead
• United States Air Force: collaborator

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45219, United States

Location

Results Point of Contact

• Title: Richard Branson
• Organization: University of Cincinnati

bransonrd@uc.edu

513-558-6785

Study Officials

• Richard D Branson, MSc RRT

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: November 22, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 20, 2024
• Results First Posted: March 12, 2013

Record last verified: 2024-09

Locations

US (1)