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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Arrest, Hyperventilation

Intervention / Treatment
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* Device: Handivent Ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACLS- certified healthcare professional Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPR simulation<br>CPR simulation with and without ventilator | Device: Handivent Ventilator<br>* CPR with use of a turbine-driven ventilator (Handivent)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. |