- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090452
Mobile Transmission of Prehospital Vital Signs to the Emergency Department
April 23, 2014 updated by: Nikolaj Raaber, University of Aarhus
Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and the Healthcare System: Study 1: "Mobile Transmission of Prehospital Vital Signs to the Emergency Department - Effect on Patient Outcomes, Treatment and Diagnosis"
The purpose of this study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Not Applicable
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
-
-
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Aarhus N, Denmark, 8200
- Prehospital Emergency Medical Services, Aarhus, Central Denmark Region
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Horsens, Denmark, 8700
- Horsens Regional Hospital, Central Region Denmark
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Horsens, Denmark, 8700
- Responce A/S
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-
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
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients transported with ambulance to the emergency department
Exclusion Criteria:
- None
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
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transmission of vital signs, ecg, chat
Data from patients transported in ambulances with equipment which enables real time transmission of vital signs, ecg and chat from ambulances to the emergency department.
|
Other Names:
|
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No Intervention: No transmission of data
Patient transported with conventional ambulances without the possibility to transmit real time patient related data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to physician
Time Frame: Time from arrival to first patient-physician contact, assessed up to 36 months
|
Time from the patient arrival registered in the patients' logistics system (Cetrea) to registered first patient/physician contact registered in the same patients logistics system.
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Time from arrival to first patient-physician contact, assessed up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All cause mortality
Time Frame: 30 days, assessed up to 36 months
|
30 days, assessed up to 36 months
|
|
|
Time to treatment
Time Frame: Time from arrival to administration of first iv. antibiotics, assessed up to 36 months
|
Time from the patient arrival registered in the patients' logistics system (Cetrea) to first administered iv antibiotics registered in the patient's hospital record
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Time from arrival to administration of first iv. antibiotics, assessed up to 36 months
|
|
Time to x-ray
Time Frame: Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months
|
Time from the patient arrival registered in the patients' logistics system (Cetrea) to completion of x-ray requisition form registered in the radiologic logistics system (Kodak RIS, 2010 edition)
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Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months
|
|
Time to ICU
Time Frame: Time from arrival to admission to the ICU, assessed up to 36 months
|
Time from the patient arrival registered in the patients' logistics system (Cetrea) to time of admission to the ICU registered in the patient's hospital record. .
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Time from arrival to admission to the ICU, assessed up to 36 months
|
|
Number of ICU admissions
Time Frame: During present hospitalization, assessed up to 36 months
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During present hospitalization, assessed up to 36 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency department staff evaluation of usability of equipment
Time Frame: At the time of using the equipment, assessed up to 36 months
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The staff at the emergency department fill out a survey after the use of the equipment which provides ecg, vital signs, chat.
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At the time of using the equipment, assessed up to 36 months
|
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Ambulance staff evaluation of usability of equipment
Time Frame: At the time of using the equipment, assessed up to 36 months
|
The ambulance staff fill out a survey after the use of the equipment which provides ecg, vital signs, chat.
|
At the time of using the equipment, assessed up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Erika F. Christensen, MD, Medical director, Central Denmark Region
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
June 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
February 20, 2014
First Submitted That Met QC Criteria
March 14, 2014
First Posted (Estimate)
March 18, 2014
Study Record Updates
Last Update Posted (Estimate)
April 24, 2014
Last Update Submitted That Met QC Criteria
April 23, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRAA
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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