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OpenTrials
Completed

NCT Number: NCT02743299

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

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Hyperventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ACLS- certified healthcare professional

Exclusion criteria

  • none

Treatment and study plan

Handivent Ventilator

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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