This trial is active, not recruiting.

Condition stroke
Treatment telemedicine
Sponsor Universitair Ziekenhuis Brussel
Collaborator Research Foundation Flanders
Start date November 2014
End date February 2016
Trial size 140 participants
Trial identifier NCT02270541, 2014-003463-38


Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
(No Intervention)
Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures.
In-ambulance teleconsultation by a stroke expert aiming to support the Paramedic Intervention Team by focusing on patient identification, obtaining homeostasis (optimal control of blood pressure, blood oxygenation, temperature, heart rate and rhythm, glycemia), assessment of the patient's neurological status, stroke diagnosis, hospital notification, and patient selection for specific stroke treatment.
In-ambulance telemedicine

Primary Outcomes

Call-to-brain imaging time
time frame: within 2 hours

Secondary Outcomes

Medical events during in-ambulance telemedicine
time frame: within 2 hours
Recanalisation therapy
time frame: upto 8 hours
Clinical outcome
time frame: upto 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel - Age >= 18 years - Suspicion of acute stroke with symptom onset < 12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion. Exclusion Criteria: - Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.

Additional Information

Official title Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke
Description The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke. The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Universitair Ziekenhuis Brussel.