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

NCT ID: NCT01477710

Last Updated: 2024-09-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

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.

Conditions

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Pre-hospital Ventilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hold mask

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Strap Mask

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Airway

Intervention Type 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.

Interventions

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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.

Intervention Type 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

Intervention Type 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.

Intervention Type PROCEDURE

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

\-
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Air Force

FED

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Rich Branson, M.D.

Professor Emeritus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard D Branson, MSc RRT

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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Branson-2010-01

Identifier Type: -

Identifier Source: org_study_id

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