Prehospital Telemedical Support in Acute Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01644019
First received: July 12, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Acute Stroke
Procedure: Teleconsultation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prehospital Telemedical Support in Acute Stroke

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Quality of prehospital care [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
    Analysis of the quality of prehospital care on the basis of published guidelines for acute stroke


Secondary Outcome Measures:
  • Clinical time intervals [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Prehospital and in-hospital time intervals: on-scene-time, contact to hospital time, door (hospital) to cerebral imaging, door (hospital) to thrombolysis

  • Diagnostic quality [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Comparison of prehospital and definitive diagnosis

  • Information transfer [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Amount of stroke specific information that is transferred to the admitting hospital.

  • choice of appropriate hospital [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
    Evaluation how many patients are transported to an appropriate facility (stroke unit)


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device: Teleconsultation
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
Teleconsultation of an EMS physician in cases of suspected acute stroke

Detailed Description:

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute stroke (including intracranial hemorrhage), the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no suspected stroke
  • patient refuses consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644019

Locations
Germany
University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Rolf Rossaint, Prof. Dr. University Hospital Aachen, Germany, Department of Anesthesiology
Principal Investigator: Jörg C Brokmann, Dr. University Hospital Aachen, Germany, Emergency Department
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01644019     History of Changes
Other Study ID Numbers: 005-1003-0034-2, PtJ-Az.: z0909im002b
Study First Received: July 12, 2012
Last Updated: August 22, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by RWTH Aachen University:
stroke
teleconsultation
telemedicine
emergency medical service

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014