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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Video-assisted CPR
telephone-assisted CPR
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

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

Inclusion Criteria:

  • healthy volunteer

Exclusion Criteria:

  • healthcare providers (medical practitioners, nurses, paramedics etc.)
  • pregnant women
  • people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 8 minutes

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

unassisted CPR

T-CPR

V-CPR

Arm Description

unassisted CPR

telephone assisted CPR according to ERC Guidelines 2015

video-assisted CPR according to ERC Guidelines 2015

Outcomes

Primary Outcome Measures

CPR Compression Frequency
CPR Compression Frequency

Secondary Outcome Measures

Compression Depth
Compression Depth
Cumulative No-Flow Time
Cumulative No-Flow Time
Time to diagnosis
Time to diagnosis
Time to beginning of chest compressions
Time to beginning of chest compressions

Full Information

First Posted
May 3, 2018
Last Updated
August 28, 2018
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT03527771
Brief Title
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study
Official Title
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 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 trail yet and no data exists that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander CPR-performance.
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. This technology hasn't been tested in a randomized controlled trail yet and no data exists that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander CPR-performance.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unassisted CPR
Arm Type
No Intervention
Arm Description
unassisted CPR
Arm Title
T-CPR
Arm Type
Active Comparator
Arm Description
telephone assisted CPR according to ERC Guidelines 2015
Arm Title
V-CPR
Arm Type
Experimental
Arm Description
video-assisted CPR according to ERC Guidelines 2015
Intervention Type
Device
Intervention Name(s)
Video-assisted CPR
Intervention Description
Emergency call using a Software capable of video Transmission for Video assistance in CPR
Intervention Type
Drug
Intervention Name(s)
telephone-assisted CPR
Intervention Description
Emergency call with telephone assistance in CPR
Primary Outcome Measure Information:
Title
CPR Compression Frequency
Description
CPR Compression Frequency
Time Frame
8 minutes
Secondary Outcome Measure Information:
Title
Compression Depth
Description
Compression Depth
Time Frame
8 minutes
Title
Cumulative No-Flow Time
Description
Cumulative No-Flow Time
Time Frame
Up to 8 minutes
Title
Time to diagnosis
Description
Time to diagnosis
Time Frame
Up to 8 minutes
Title
Time to beginning of chest compressions
Description
Time to beginning of chest compressions
Time Frame
Up to 8 minutes

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 volunteer Exclusion Criteria: healthcare providers (medical practitioners, nurses, paramedics etc.) pregnant women people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 8 minutes
Facility Information:
Facility Name
Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Cologne
City
Cologne
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32073408
Citation
Ecker H, Lindacher F, Adams N, Hamacher S, Wingen S, Schier R, Bottiger BW, Wetsch WA. Video-assisted cardiopulmonary resuscitation via smartphone improves quality of resuscitation: A randomised controlled simulation trial. Eur J Anaesthesiol. 2020 Apr;37(4):294-302. doi: 10.1097/EJA.0000000000001177.
Results Reference
derived

Learn more about this trial

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

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