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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743299
• Other study ID #: 00063298
• 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

• Cardiac Arrest
• Heart Arrest
• Hyperventilation

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