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Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation

Primary Purpose

Cardiac Arrest, Hyperventilation

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Handivent Ventilator
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ACLS- certified healthcare professional

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CPR simulation

    Arm Description

    CPR simulation with and without ventilator

    Outcomes

    Primary Outcome Measures

    Respiratory rate
    The study will measure the respiratory rate delivered during the 8-minute CPR scenario

    Secondary Outcome Measures

    Tidal volume
    The study will measure the tidal volume delivered during the 8-minute CPR scenario
    Peak Inspiratory pressure
    the study will measure the peak inspiratory pressure delivered during the 8-minute CPR scenario

    Full Information

    First Posted
    April 1, 2016
    Last Updated
    August 8, 2016
    Sponsor
    University of Utah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02743299
    Brief Title
    Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation
    Official Title
    Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Utah

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to determine whether healthcare professionals trained in CPR can deliver more effective ventilations during CPR using the Handivent, a novel turbine-driven ventilator as compared to bag-valve-mask ventilations, using a manikin model. The investigators believe the Handivent will deliver a more accurate respiratory rate and tidal volume, with lower intrathoracic pressure during CPR.
    Detailed Description
    Previous studies have shown that increased respiratory rate during CPR inversely correlates with blood pressure. Higher respiratory rates increase intrathoracic pressure, which in turn decreases venous return to the heart. In one previous study, the authors looked at 3 groups of 7 pigs, ventilated at 12 (100% O2), 30 (100%), and 30 (5% CO2, 95% 02) breaths per minute during cardiac arrest, and showed increased mortality with increasing respiratory rate. Survival rates were 6/7, 1/7, and 1/7 respectively. The results of this study led to changing the CPR guidelines in 2005 to include fewer ventilations. The authors also observed 13 cases of CPR in the field and noted EMS personnel delivered breaths at an average of 32 bpm. In 2012, a similar study to the current study under proposal compared a pressure-limited, pneumatically driven ventilator to bag-valve-mask in simulated CPR, using medical student volunteers. That study did not show a significant difference in tidal volumes; however, they did not record respiratory rates or mean intrathoracic pressures. Furthermore, that ventilator was pneumatically -driven and pressure limited, whereas the ventilator we propose to study is turbine-driven and can be volume/time triggered.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Hyperventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CPR simulation
    Arm Type
    Experimental
    Arm Description
    CPR simulation with and without ventilator
    Intervention Type
    Device
    Intervention Name(s)
    Handivent Ventilator
    Intervention Description
    CPR with use of a turbine-driven ventilator (Handivent)
    Primary Outcome Measure Information:
    Title
    Respiratory rate
    Description
    The study will measure the respiratory rate delivered during the 8-minute CPR scenario
    Time Frame
    RR will be the average RR during the CPR simulation, which is 8-minutes in duration.
    Secondary Outcome Measure Information:
    Title
    Tidal volume
    Description
    The study will measure the tidal volume delivered during the 8-minute CPR scenario
    Time Frame
    Average Vt during CPR simulation, which is 8 minutes in duration
    Title
    Peak Inspiratory pressure
    Description
    the study will measure the peak inspiratory pressure delivered during the 8-minute CPR scenario
    Time Frame
    Average PIP delivered during CPR simulation, which is 8 minutes in duration.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ACLS- certified healthcare professional Exclusion Criteria: none
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott Allen, MD
    Organizational Affiliation
    University of Utah
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28807986
    Citation
    Allen SG, Brewer L, Gillis ES, Pace NL, Sakata DJ, Orr JA. A Turbine-Driven Ventilator Improves Adherence to Advanced Cardiac Life Support Guidelines During a Cardiopulmonary Resuscitation Simulation. Respir Care. 2017 Sep;62(9):1166-1170. doi: 10.4187/respcare.05368. Epub 2017 Aug 14.
    Results Reference
    derived

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    Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation

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