Video-assisted Telephone CPR With the EmergencyEye-Softwa... | NCT03527771

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

NCT03527771

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Aug 31, 2018Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Cardiac Arrest

Interventions

Video-assisted CPR
telephone-assisted CPR

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2018Actual

Primary Completion Date

Aug 28, 2018Actual

Completion Date

Aug 28, 2018Actual

First Submitted Date

May 3, 2018

First Submission Date that Met QC Criteria

May 16, 2018

First Posted Date

May 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2018

Last Update Posted Date

Aug 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. med. Wolfgang A. Wetsch, Principal Investigator, University of ColognePrincipal Investigator

Lead Sponsor

University of CologneOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
unassisted CPR	No Intervention	unassisted CPR
T-CPR	Active Comparator	telephone assisted CPR according to ERC Guidelines 2015	Drug: telephone-assisted CPR
V-CPR	Experimental	video-assisted CPR according to ERC Guidelines 2015	Device: Video-assisted CPR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video-assisted CPR	Device	Emergency call using a Software capable of video Transmission for Video assistance in CPR	V-CPR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPR Compression Frequency	CPR Compression Frequency	8 minutes

Secondary Outcomes

Measure	Description	Time Frame
Compression Depth	Compression Depth	8 minutes
Cumulative No-Flow Time	Cumulative No-Flow Time	Up to 8 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Cologne		Cologne			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32073408	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases