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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02743299
Other study ID # 00063298
Secondary ID
Status Completed
Phase Phase 0
First received April 1, 2016
Last updated August 8, 2016
Start date April 2013
Est. completion date April 2016

Study information

Verified date August 2016
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 2016
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- ACLS- certified healthcare professional

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Handivent Ventilator
CPR with use of a turbine-driven ventilator (Handivent)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory rate The study will measure the respiratory rate delivered during the 8-minute CPR scenario RR will be the average RR during the CPR simulation, which is 8-minutes in duration. No
Secondary Tidal volume The study will measure the tidal volume delivered during the 8-minute CPR scenario Average Vt during CPR simulation, which is 8 minutes in duration No
Secondary Peak Inspiratory pressure the study will measure the peak inspiratory pressure delivered during the 8-minute CPR scenario Average PIP delivered during CPR simulation, which is 8 minutes in duration. No
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