NCT02743299

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2013

Typical duration for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

April 1, 2016

Last Update Submit

August 8, 2016

Conditions

Cardiac ArrestHyperventilation

Outcome Measures

Primary Outcomes (1)

  • Respiratory rate

    The study will measure the respiratory rate delivered during the 8-minute CPR scenario

    RR will be the average RR during the CPR simulation, which is 8-minutes in duration.

Secondary Outcomes (2)

  • Tidal volume

    Average Vt during CPR simulation, which is 8 minutes in duration

  • Peak Inspiratory pressure

    Average PIP delivered during CPR simulation, which is 8 minutes in duration.

Study Arms (1)

CPR simulation

EXPERIMENTAL

CPR simulation with and without ventilator

Device: Handivent Ventilator

Interventions

Handivent VentilatorDEVICE

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

CPR simulation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ACLS- certified healthcare professional

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28807986DERIVED

MeSH Terms

Conditions

Heart ArrestHyperventilation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Scott Allen, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 19, 2016

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

April 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share