Back to resultsPrehospital Study at the Universitair Ziekenhuis Brussel II (PreSSUB II)
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke focused on measuring Telemedicine, Prehospital, Emergency Medicine, Stroke
Eligibility Criteria
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.
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Telemedicine
Arm Description
Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures.
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.
Outcomes
Primary Outcome Measures
Call-to-brain imaging time
Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.
Secondary Outcome Measures
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)
Recanalisation therapy
Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).
Clinical outcome
Assessment of the functional status
Full Information
NCT ID
NCT02270541
First Posted
October 16, 2014
Last Updated
March 1, 2016
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Research Foundation Flanders, Vrije Universiteit Brussel, Brussels Institute for Research and Innovation (INNOVIRIS), King Baudouin Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02270541
Brief Title
Prehospital Study at the Universitair Ziekenhuis Brussel II
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Research Foundation Flanders, Vrije Universiteit Brussel, Brussels Institute for Research and Innovation (INNOVIRIS), King Baudouin Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Telemedicine, Prehospital, Emergency Medicine, Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures.
Arm Title
Telemedicine
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
In-ambulance telemedicine
Primary Outcome Measure Information:
Title
Call-to-brain imaging time
Description
Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.
Time Frame
within 2 hours
Secondary Outcome Measure Information:
Title
Medical events during in-ambulance telemedicine
Description
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)
Time Frame
within 2 hours
Title
Recanalisation therapy
Description
Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).
Time Frame
upto 8 hours
Title
Clinical outcome
Description
Assessment of the functional status
Time Frame
upto 12 months
Other Pre-specified Outcome Measures:
Title
Mortality
Description
Mortality 90 (± 10) days after stroke
Time Frame
upto 100 days
Title
Adverse event
Description
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)
Time Frame
upto 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques De Keyser, MD PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Prehospital Study at the Universitair Ziekenhuis Brussel II
We'll reach out to this number within 24 hrs