search
Back to results

Prehospital Telemedical Support in Acute Stroke

Primary Purpose

Acute Stroke

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Teleconsultation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring stroke, teleconsultation, telemedicine, emergency medical service

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device: Teleconsultation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical time intervals
Prehospital and in-hospital time intervals: on-scene-time, contact to hospital time, door (hospital) to cerebral imaging, door (hospital) to thrombolysis
Diagnostic quality
Comparison of prehospital and definitive diagnosis
Information transfer
Amount of stroke specific information that is transferred to the admitting hospital.
choice of appropriate hospital
Evaluation how many patients are transported to an appropriate facility (stroke unit)

Full Information

First Posted
July 12, 2012
Last Updated
September 21, 2015
Sponsor
RWTH Aachen University
search

1. Study Identification

Unique Protocol Identification Number
NCT01644019
Brief Title
Prehospital Telemedical Support in Acute Stroke
Official Title
Prehospital Telemedical Support in Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, teleconsultation, telemedicine, emergency medical service

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: Teleconsultation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Teleconsultation
Intervention Description
Teleconsultation of an EMS physician in cases of suspected acute stroke
Primary Outcome Measure Information:
Title
Quality of prehospital care
Description
Analysis of the quality of prehospital care on the basis of published guidelines for acute stroke
Time Frame
average 1 hour
Secondary Outcome Measure Information:
Title
Clinical time intervals
Description
Prehospital and in-hospital time intervals: on-scene-time, contact to hospital time, door (hospital) to cerebral imaging, door (hospital) to thrombolysis
Time Frame
12 hours
Title
Diagnostic quality
Description
Comparison of prehospital and definitive diagnosis
Time Frame
up to 28 days
Title
Information transfer
Description
Amount of stroke specific information that is transferred to the admitting hospital.
Time Frame
2 hours
Title
choice of appropriate hospital
Description
Evaluation how many patients are transported to an appropriate facility (stroke unit)
Time Frame
average 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Rossaint, Prof. Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Department of Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jörg C Brokmann, Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Prehospital Telemedical Support in Acute Stroke

We'll reach out to this number within 24 hrs