NCT02090452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

February 20, 2014

Last Update Submit

April 23, 2014

Conditions

TelemedicineTriageEmergency Medical Service

Keywords

TelemedicineMobileVital signsPrehospital careEmergency medicine

Outcome Measures

Primary Outcomes (1)

  • Time to physician

    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.

    Time from arrival to first patient-physician contact, assessed up to 36 months

Secondary Outcomes (5)

  • All cause mortality

    30 days, assessed up to 36 months

  • Time to treatment

    Time from arrival to administration of first iv. antibiotics, assessed up to 36 months

  • Time to x-ray

    Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months

  • Time to ICU

    Time from arrival to admission to the ICU, assessed up to 36 months

  • Number of ICU admissions

    During present hospitalization, assessed up to 36 months

Other Outcomes (2)

  • Emergency department staff evaluation of usability of equipment

    At the time of using the equipment, assessed up to 36 months

  • Ambulance staff evaluation of usability of equipment

    At the time of using the equipment, assessed up to 36 months

Study Arms (2)

Transmission of vital signs, ecg, chat

EXPERIMENTAL

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.

Device: Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden

No transmission of data

NO INTERVENTION

Patient transported with conventional ambulances without the possibility to transmit real time patient related data.

Interventions

Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB SwedenDEVICE
Also known as: Vital signs, ECG and Chat-messaging delivered real time from prehospital ambulances to the receiving emergency dept.
Transmission of vital signs, ecg, chat

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients transported with ambulance to the emergency department

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prehospital Emergency Medical Services, Aarhus, Central Denmark Region

Aarhus N, 8200, Denmark

Location

Horsens Regional Hospital, Central Region Denmark

Horsens, 8700, Denmark

Location

Responce A/S

Horsens, 8700, Denmark

Location

MeSH Terms

Interventions

Vital SignsElectrocardiography

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosis

Study Officials

  • Erika F. Christensen, MD, Medical director

    Central Denmark Region

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 18, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

DK(3)