NCT02924805

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

October 3, 2016

Last Update Submit

October 3, 2016

Conditions

Hypertensive EmergencyHypertensive Urgency

Outcome Measures

Primary Outcomes (1)

  • Blood pressure difference between initial contact and emergency room handover

    2 hours

Secondary Outcomes (2)

  • Difference of heart rate between initial contact and emergency room handover

    2 hours

  • Magnitude of blood pressure reduction using categories

    2 hours

Other Outcomes (2)

  • Analysis of administered antihypertensive agents

    2 hours

  • context specific quality of medical history and documentation

    2 hours

Study Arms (2)

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.

Other: Telemedical care

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).

Interventions

Telemedical careOTHER

Telemedically guided care based on a standard operating procedure

Telemedicine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients whith a prehospital diagnosis of hypertensive emergency or urgency

You may qualify if:

  • prehospital diagnosis of hypertensive emergency of hypertensive urgency

You may not qualify if:

  • Prehospital diagnoses of:
  • pulmonary edema
  • aortic dissection
  • acute coronary syndrome
  • acute stroke
  • acute respiratory insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Hypertensive Crisis

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Jörg Ch Brokmann, Dr. med.

    University Hospital Aachen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

November 1, 2013

Primary Completion

March 1, 2015

Study Completion

August 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)