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

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

      • Aachen, Germany, 52074
        • University Hospital Aachen

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.
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).

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
2 hours

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)
2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of administered antihypertensive agents
Time Frame: 2 hours
2 hours
context specific quality of medical history and documentation
Time Frame: 2 hours
Analysis of medical history and vital parameter documentation completeness
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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