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Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EmergencyEye
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • cardiovascular diseases
  • pulmonary diseases
  • pregnancy
  • all other conditions that make CPR impossible

Sites / Locations

  • Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional emergency call

EmergencyEye emergency call

Arm Description

Emergency call with conventinal cell phone: verbal description of location telephone-assisted CPR

Emergency call with EmergencyEye App on cell phone: automated geolocalisation video-assisted CPR

Outcomes

Primary Outcome Measures

Recognition of CPR quality through video transmission
Recognition of CPR quality (3 conditions are randomized in each CPR, i.e. Frequency, Compression Depth, Compression Point) in Video-assisted CPR

Secondary Outcome Measures

Time to first chest compression
Time measured from the beginning of the emergency call to the first chest compression
Precision of Geolocalisation
Precision of Geolocalisation, i.e. difference between verbally localized and automatically localized (aGPS) respondes to emergency call. Difference in runtimes of dispatched ambulances will be calculated

Full Information

First Posted
August 25, 2018
Last Updated
October 3, 2018
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT03654846
Brief Title
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
Official Title
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 25, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service. In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable. This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.
Detailed Description
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service. In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable, and automated localisation of the caller. This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Test of EmergencyEye functionality in real environment, comparison with conventional emergency call.
Masking
Care Provider
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional emergency call
Arm Type
No Intervention
Arm Description
Emergency call with conventinal cell phone: verbal description of location telephone-assisted CPR
Arm Title
EmergencyEye emergency call
Arm Type
Experimental
Arm Description
Emergency call with EmergencyEye App on cell phone: automated geolocalisation video-assisted CPR
Intervention Type
Device
Intervention Name(s)
EmergencyEye
Intervention Description
EmergencyEye Smartphone App
Primary Outcome Measure Information:
Title
Recognition of CPR quality through video transmission
Description
Recognition of CPR quality (3 conditions are randomized in each CPR, i.e. Frequency, Compression Depth, Compression Point) in Video-assisted CPR
Time Frame
1 minute of CPR
Secondary Outcome Measure Information:
Title
Time to first chest compression
Description
Time measured from the beginning of the emergency call to the first chest compression
Time Frame
Study duration (approx. 1 minute)
Title
Precision of Geolocalisation
Description
Precision of Geolocalisation, i.e. difference between verbally localized and automatically localized (aGPS) respondes to emergency call. Difference in runtimes of dispatched ambulances will be calculated
Time Frame
Study duration (approx. 1 minute)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers Exclusion Criteria: cardiovascular diseases pulmonary diseases pregnancy all other conditions that make CPR impossible
Facility Information:
Facility Name
Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
City
Cologne
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept

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