Hypertensive EmergencyNCT02924805
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies
An observational study of Hypertensive Emergency and Hypertensive Urgency, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Emergency, Hypertensive Urgency
- What is being tested?
- Telemedical care
- How many people
- 331 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whith a prehospital diagnosis of hypertensive emergency or urgency
Who may be able to join
- prehospital diagnosis of hypertensive emergency of hypertensive urgency
Who cannot join
- Prehospital diagnoses of:
- pulmonary edema
- aortic dissection
- acute coronary syndrome
- acute stroke
- acute respiratory insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Hypertensive Emergency, Hypertensive Urgency
- Being tested
- Telemedical care
- Medical subject headings
- Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedical careOther
Telemedically guided care based on a standard operating procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure difference between initial contact and emergency room handover
Measured: 2 hours
Secondary outcomes (2)
Difference of heart rate between initial contact and emergency room handover
Measured: 2 hours
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)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive EmergencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg Ch Brokmann, Dr. med., Principal investigator, University Hospital Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924805
- Sponsor's protocol ID
- TECH
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies and Urgencies
- ClinicalTrials.gov ID
- NCT02924805
- Acronym / sponsor ID
- TECH
- Conditions
- Hypertensive Emergency, Hypertensive Urgency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine group | – | Other: Telemedical careCases 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whith a prehospital diagnosis of hypertensive emergency or urgency
Key inclusion criteria (1 listed)
- prehospital diagnosis of hypertensive emergency of hypertensive urgency
Key exclusion criteria (6 listed)
- pulmonary edema
- aortic dissection
- acute coronary syndrome
- acute stroke
- acute respiratory insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedical careTelemedically guided care based on a standard operating procedure | Other | Telemedicine group |
Primary outcome
Blood pressure difference between initial contact and emergency room handover
Time frame: 2 hours
2 secondary outcomes
Difference of heart rate between initial contact and emergency room handover
Time frame: 2 hours
Magnitude of blood pressure reduction using categories
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Ch Brokmann, Dr. med. principal investigator
University Hospital Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Emergency and Hypertensive Urgency, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure difference between initial contact and emergency room handover (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.