Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies

Hypertensive Urgency Clinical Trial

Official title:

Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies and Urgencies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924805
• Other study ID #: TECH
• 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

• Emergencies
• Hypertensive Emergency
• Hypertensive Urgency

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