Prehospital Study at the Universitair Ziekenhuis Brussel II

Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02270541

Acronym

PreSSUB II

Enrollment

140

Registered

2014-10-21

Start date

2014-11-30

Completion date

2017-02-28

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Telemedicine, Prehospital, Emergency Medicine, Stroke

Brief summary

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.

Interventions

OTHERTelemedicine

In-ambulance telemedicine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Call-to-brain imaging time	within 2 hours	Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.

Secondary

Measure	Time frame	Description
Medical events during in-ambulance telemedicine	within 2 hours	Prevalence of medical events diagnosed and corrected during in-ambulance telemedicine (e.g. blood oxygen desaturation, arterial hypertension, arterial hypotension, hypoglycemia, hyperglycemia, cardiac arrhythmia, decreased level of consciousness, hyperthermia)
Recanalisation therapy	upto 8 hours	Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).
Clinical outcome	upto 12 months	Assessment of the functional status

Other

Measure	Time frame	Description
Mortality	upto 100 days	Mortality 90 (± 10) days after stroke
Adverse event	upto 12 months	In-hospital mortality and any adverse event, in particular known complications of delayed stroke care and thrombolytic therapy (e.g. intracranial hemorrhage, systemic bleeding requiring transfusion, inappropriate use of recanalization therapy)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026