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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02743299
Enrollment
24
Registered
2016-04-19
Start date
2013-04-30
Completion date
2016-04-30
Last updated
2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Hyperventilation

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.

Interventions

DEVICEHandivent Ventilator

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

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* ACLS- certified healthcare professional

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Respiratory rateRR 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

MeasureTime frameDescription
Tidal volumeAverage Vt during CPR simulation, which is 8 minutes in durationThe study will measure the tidal volume delivered during the 8-minute CPR scenario
Peak Inspiratory pressureAverage 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026