Prehospital Study at the Universitair Ziekenhuis Brussel II (PreSSUB II)

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Stroke

Treatments: Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02270541

2014-003463-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Control

No Intervention group

Description:

Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures.

Telemedicine

Experimental group

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.

Treatment:

Other: Telemedicine