- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924805
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies
October 3, 2016 updated by: RWTH Aachen University
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies and Urgencies
Comparison of telemedical prehospital emergency care and conventional on-scene physician based care of hypertensive emergencies and urgencies.
The adherence to current Guidelines should be researched.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Telemedically guided cases of hypertensive emergencies (april 2014 - March 2015) and urgencies are compared with a historical control group of conventional emergency medical service physician care on-scene for these scenarios.
The historical control group is a time period prior to implementation of the telemedicine system and after a research project with a precursor telemedicine system.
No telemedical support but only conventional on-scene EMS physician care was available (November 2013 - March 2014).
Study Type
Observational
Enrollment (Actual)
331
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aachen, Germany, 52074
- University Hospital Aachen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients whith a prehospital diagnosis of hypertensive emergency or urgency
Description
Inclusion Criteria:
- prehospital diagnosis of hypertensive emergency of hypertensive urgency
Exclusion Criteria:
Prehospital diagnoses of:
- pulmonary edema
- aortic dissection
- acute coronary syndrome
- acute stroke
- acute respiratory insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Telemedicine group
Cases of hypertensive emergencies and urgencies in which the prehospital emergency care was performed by on-scene paramedics, guided by a qualified physician in a teleconsultation center.
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Telemedically guided care based on a standard operating procedure
|
Control group
Historical cases of of hypertensive emergencies and urgencies in which the prehospital emergency care was carried out by on-scene emergency medical service physicians (conventional care).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure difference between initial contact and emergency room handover
Time Frame: 2 hours
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2 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of heart rate between initial contact and emergency room handover
Time Frame: 2 hours
|
2 hours
|
|
Magnitude of blood pressure reduction using categories
Time Frame: 2 hours
|
To measure guideline adherence blood pressure (BP) reductions were evaluated with four categories: no BP reduction, reduction <= 25%, reduction >25-30%, reduction > 30% (BP difference between initial contact and emergency room handover)
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2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of administered antihypertensive agents
Time Frame: 2 hours
|
2 hours
|
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context specific quality of medical history and documentation
Time Frame: 2 hours
|
Analysis of medical history and vital parameter documentation completeness
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2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jörg Ch Brokmann, Dr. med., University Hospital Aachen, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 5, 2016
Study Record Updates
Last Update Posted (Estimate)
October 5, 2016
Last Update Submitted That Met QC Criteria
October 3, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tech (Other Identifier: TexasTechU)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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