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

Early Phase 1

Completed

• Conditions: Hyperventilation; Cardiac Arrest
• Interventions: Device: Handivent Ventilator

• Registration Number: NCT02743299
• Lead Sponsor: University of Utah

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2016-04
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• ACLS- certified healthcare professional

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPR simulation	Handivent Ventilator	CPR simulation with and without ventilator

Primary Outcome Measures

Name	Time	Method
Respiratory rate	RR will be the average RR during the CPR simulation, which is 8-minutes in duration.	The study will measure the respiratory rate delivered during the 8-minute CPR scenario

Secondary Outcome Measures

Name	Time	Method
Tidal volume	Average Vt during CPR simulation, which is 8 minutes in duration	The study will measure the tidal volume delivered during the 8-minute CPR scenario
Peak Inspiratory pressure	Average PIP delivered during CPR simulation, which is 8 minutes in duration.	the study will measure the peak inspiratory pressure delivered during the 8-minute CPR scenario