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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pre-hospital Ventilation

Intervention / Treatment
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* Procedure: Hold mask
* Procedure: Strap Mask
* Procedure: Airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary participation Nurse, respiratory therapist, or physician involved in the care of patients requiring ventilation and airway management Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hold Mask<br>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<br>* 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.<br>|
| Active Comparator: Strap Mask<br>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<br>* The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes<br>|
| Active Comparator: Airway<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Tidal volume, Respiratory rate