Prehospital Study at the Universitair Ziekenhuis Brussel II "PreSSUB II"

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Telemedicine Other
    Intervention Desc: In-ambulance telemedicine
    ARM 1: Kind: Experimental
    Label: Telemedicine
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Call-to-brain imaging time within 2 hours No
Secondary Medical events during in-ambulance telemedicine within 2 hours No
Secondary Recanalisation therapy upto 8 hours No
Secondary Clinical outcome upto 12 months No

Sponsors