Prehospital Study at the Universitair Ziekenhuis Brussel II

Stroke Clinical Trial

— PreSSUB II  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02270541
• Other study ID #: 2014-003463-38
• Status: Active, not recruiting
• Phase: N/A
• First received: October 16, 2014
• Last updated: March 1, 2016
• Start date: November 2014
• Est. completion date: February 2017

Study information

• Verified date: March 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: February 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Telemedicine
In-ambulance telemedicine

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (5)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Brussels Institute for Research and Innovation (INNOVIRIS), King Baudouin Foundation, Research Foundation Flanders, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Mortality 90 (± 10) days after stroke	upto 100 days	Yes
Other	Adverse event	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)	upto 12 months	Yes
Primary	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	No
Secondary	Medical events during in-ambulance telemedicine	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)	within 2 hours	No
Secondary	Recanalisation therapy	Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).	upto 8 hours	No
Secondary	Clinical outcome	Assessment of the functional status	upto 12 months	No