Clinical Trials Directory

Trials / Completed

CompletedNCT02743299

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

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICEHandivent VentilatorCPR with use of a turbine-driven ventilator (Handivent)

Timeline

Start date
2013-04-01
Primary completion
2013-06-01
Completion
2016-04-01
First posted
2016-04-19
Last updated
2016-08-10

Source: ClinicalTrials.gov record NCT02743299. Inclusion in this directory is not an endorsement.