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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Utah

Current Primary Outcome: Respiratory rate [ Time Frame: RR 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tidal volume [ Time Frame: Average Vt during CPR simulation, which is 8 minutes in duration ]
    The study will measure the tidal volume delivered during the 8-minute CPR scenario
  • Peak Inspiratory pressure [ Time Frame: Average 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


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: April 1, 2016
Date Started: April 2013
Date Completion:
Last Updated: August 8, 2016
Last Verified: August 2016