Clinical trial NCT02743299: Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation
Official title: Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiac Arrest
Hyperventilation
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* ACLS- certified healthcare professional

Exclusion Criteria:

* none

Primary outcomes:
measure: Respiratory rate
timeFrame: RR will be the average RR during the CPR simulation, which is 8-minutes in duration.
Secondary outcomes:
measure: Tidal volume
timeFrame: Average Vt during CPR simulation, which is 8 minutes in duration
measure: Peak Inspiratory pressure
timeFrame: Average PIP delivered during CPR simulation, which is 8 minutes in duration.
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Scott Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.