Prehospital Study at the Universitair Ziekenhuis Brussel II

NCT02270541 | Unknown DMC

• 1 other identifier: 2014-003463-38
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Telemedicine; Prehospital; Emergency Medicine; Stroke

Outcome Measures

Primary Outcomes (1)

• Call-to-brain imaging time

  Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.

  within 2 hours

Secondary Outcomes (3)

• Medical events during in-ambulance telemedicine

  within 2 hours

• Recanalisation therapy

  upto 8 hours

• Clinical outcome

  upto 12 months

Other Outcomes (2)

• Mortality

  upto 100 days

• Adverse event

  upto 12 months

Study Arms (2)

Control

NO INTERVENTION

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

Telemedicine

EXPERIMENTAL

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.

Other: Telemedicine

Interventions

Telemedicine OTHER

In-ambulance telemedicine

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Research Foundation Flanders: collaborator
• Vrije Universiteit Brussel: collaborator
• Brussels Institute for Research and Innovation (INNOVIRIS): collaborator
• King Baudouin Foundation: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jacques De Keyser, MD PhD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 2, 2016

Record last verified: 2016-03

Locations

BE (1)