NCT03654846

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 25, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

August 25, 2018

Last Update Submit

October 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 minute of CPR

Secondary Outcomes (2)

  • Time to first chest compression

    Study duration (approx. 1 minute)

  • Precision of Geolocalisation

    Study duration (approx. 1 minute)

Study Arms (2)

Conventional emergency call

NO INTERVENTION

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

EmergencyEye emergency call

EXPERIMENTAL

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

Device: EmergencyEye

Interventions

EmergencyEye Smartphone App

EmergencyEye emergency call

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cologne, Germany

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Test of EmergencyEye functionality in real environment, comparison with conventional emergency call.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 25, 2018

First Posted

August 31, 2018

Study Start

August 25, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations