NCT01647854

Brief Summary

The aim of the study is to investigate the safety and efficacy of the operation of a prehospital teleconsultation system in the Emergency Medical Service.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

July 16, 2012

Last Update Submit

September 22, 2015

Conditions

Keywords

emergency medical servicetelemedicineteleconsultationsafety

Outcome Measures

Primary Outcomes (1)

  • Rate of complications

    The incidence of complications due to delegated medications should be evaluated.

    up to 2 hours

Secondary Outcomes (4)

  • Time intervals

    up to 2 hours

  • Duration of teleconsultation

    up to 2 hours

  • Requirement of on-scene EMS physician

    up to 2 hours

  • Technical assessments

    up to 2 hours

Study Arms (1)

Device: Teleconsultation

EXPERIMENTAL

If patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with an audio-connection to the EMS team who receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety and efficacy of the introduction and operation of this system should be evaluated.

Procedure: Teleconsultation

Interventions

Teleconsultation in prehospital emergencies

Device: Teleconsultation

Eligibility Criteria

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

You may qualify if:

  • prehospital emergency
  • consent of the patient for teleconsultation was obtained or patient is unable to consent due to the severity of the emergency

You may not qualify if:

  • patient refuses consent for teleconsultation
  • psychiatric emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Interventions

Remote Consultation

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Rolf Rossaint, Prof. Dr.

    University Hospital Aachen, Germany, Department of Anesthesiology

    STUDY CHAIR
  • Jörg C Brokmann, Dr.

    University Hospital Aachen, Germany, Emergency Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 24, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations