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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02924805
Other study ID # TECH
Secondary ID
Status Completed
Phase N/A
First received October 3, 2016
Last updated October 3, 2016
Start date November 2013
Est. completion date August 2016

Study information

Verified date October 2016
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: University Hospital Aachen
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 331
Est. completion date August 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Telemedical care
Telemedically guided care based on a standard operating procedure

Locations

Country Name City State
Germany University Hospital Aachen Aachen

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Analysis of administered antihypertensive agents 2 hours No
Other context specific quality of medical history and documentation Analysis of medical history and vital parameter documentation completeness 2 hours No
Primary Blood pressure difference between initial contact and emergency room handover 2 hours Yes
Secondary Difference of heart rate between initial contact and emergency room handover 2 hours Yes
Secondary Magnitude of blood pressure reduction using categories 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) 2 hours Yes
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