Prehospital Telemedical Support in Acute Stroke

Acute Stroke Clinical Trial

Official title:

Prehospital Telemedical Support in Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644019
• Other study ID #: 005-1003-0034-2
• Secondary ID: PtJ-Az.: z0909im
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: September 21, 2015
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Procedure:
• Teleconsultation
Teleconsultation of an EMS physician in cases of suspected acute stroke

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of prehospital care	Analysis of the quality of prehospital care on the basis of published guidelines for acute stroke	average 1 hour	No
Secondary	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	12 hours	No
Secondary	Diagnostic quality	Comparison of prehospital and definitive diagnosis	up to 28 days	No
Secondary	Information transfer	Amount of stroke specific information that is transferred to the admitting hospital.	2 hours	No
Secondary	choice of appropriate hospital	Evaluation how many patients are transported to an appropriate facility (stroke unit)	average 1 hour	No