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
About this trial
This is an interventional treatment trial for Cardiac Arrest
Eligibility Criteria
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
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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