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

NCT ID: NCT02743299

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Cardiac Arrest; Hyperventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPR simulation

CPR simulation with and without ventilator

Group Type: EXPERIMENTAL

Handivent Ventilator

Intervention Type: DEVICE

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

Interventions

Handivent Ventilator

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ACLS- certified healthcare professional

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Scott Allen

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Allen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

References

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.

Reference Type: DERIVED

PMID: 28807986 (View on PubMed)

Other Identifiers

00063298

Identifier Type: -

Identifier Source: org_study_id