Prehospital Telemedical Support in Acute Stroke

NCT01644019 | Completed

• 2 other identifiers: 005-1003-0034-2PtJ-Az.: z0909im002b
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the quality of prehospital emergency care in acute stroke, when paramedics are supported telemedically by an EMS physician.

Conditions

Acute Stroke

Keywords

stroke; teleconsultation; telemedicine; emergency medical service

Outcome Measures

Primary Outcomes (1)

• Quality of prehospital care

  Analysis of the quality of prehospital care on the basis of published guidelines for acute stroke

  average 1 hour

Secondary Outcomes (4)

• Clinical time intervals

  12 hours

• Diagnostic quality

  up to 28 days

• Information transfer

  2 hours

• choice of appropriate hospital

  average 1 hour

Study Arms (1)

Device: Teleconsultation

EXPERIMENTAL

In cases of suspected acute stroke (including intracranial hemorrhage), if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" who has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures (taken with a smartphone), 12-lead-ECGs and video streaming from the inside of the ambulance can also be carried out, if indicated. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, neurological 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 quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Procedure: Teleconsultation

Interventions

Teleconsultation PROCEDURE

Teleconsultation of an EMS physician in cases of suspected acute stroke

Device: Teleconsultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suspected acute stroke
• verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency

You may not qualify if:

• no suspected stroke
• patient refuses consent

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Stroke

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient 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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 18, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

DE (1)