Feasibility of Telemedicine Under Ambulance Station Conditions

NCT05388071 | Completed

• 2 other identifiers: 22-130Notice No. 03/2019
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to evaluate the feasibility of telemedicine in context of medical service in an ambulance station and in a further step in context of civil defense situations. The conditions in those situations are different to the usual usage of telemedicine in context of emergency medical services (EMS) like the "Telenotarzt" in Aachen. The medical personnel who are performing the medical treatment in ambulance stations or civil defense situations are most volunteers and are ordinarily not as experienced and educated as professional medical personnel in EMS. In case of civil defense situations, the personnel also must deal with shortage in material which we are not going to simulate in our study. The study will be realized at each one ambulance station at four large-scale events. Every time there will be a telemedicine workspace with an EMS-physician educated in telemedicine who can be contacted by briefed and equipped medical personnel according to the "TeleSAN"-standard. The emergency personnel start the patient's treatment according to their known standards and decide on their own whether they want to contact the tele-EMS-physician or not. Before starting the tele-consultation, every patient must declare his consent to the tele-consultation, otherwise tele-consultation cannot be realized, and the patient needs to be treated according to common standards. Due to spatial proximity of the telemedicine workspace and the ambulance station, the tele-EMS-physician can also work as an EMS-physician in the ambulance station if necessary. As a hypothesis we declare that telemedicine is feasible in context of an ambulance station. To evaluate the feasibility, we use patient's medical protocols, observations and surveys.

Conditions

Telemedicine; Disaster Medicine; Emergency Medicine

Keywords

TeleSAN; Telemedicine; Remote Consultation; Remote Treatment; Emergency Medical Services; Disaster Medicine; Emergency Medicine; Teleconsultation; Tele-emergency physician; Quality of Health Care

Outcome Measures

Primary Outcomes (3)

• Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)

  Changes of the patient's medical condition will be measured using the german PRIOR algorithm which is used to triage patients in three categories: red, yellow and green. A change of triage category from red to yellow/green or from yellow to green means a better outcome, a change from green to yellow/red means a worse outcome.

  through study completion, in total estimated 1 year

• Improvement of vital signs

  Changes of the patient's medical condition will be measured by analyzing changes in the patient's vital signs. Changes from unphysiological to physiological vital signs mean a better outcome.

  through study completion, in total estimated 1 year

• Improvement of NACA-Score (National Advisory Committee for Aeronautics)

  Changes of the patient's medical condition will be measured using the NACA-Score. Changes from a lower to a higher score means a worse outcome.

  through study completion, in total estimated 1 years

Secondary Outcomes (1)

• Usability of the telemedicine-devices and infrastructure and their reliable function

  through study completion, in total estimated 1 year

Other Outcomes (7)

• Time for treatment

  through study completion, in total estimated 1 year

• Experience and education

  through study completion, in total estimated 1 year

• Acceptance of telemedicine

  through study completion, in total estimated 1 year

Study Arms (2)

Intervention: Treatment with the aid of telemedicine

Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible.

Other: Usage of telemedicine and tele-consultation for treatment

No intervention: Usual treatment

Treatment will be performed as usual without the usage of telemedicine.

Interventions

Usage of telemedicine and tele-consultation for treatment OTHER

Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible.

Intervention: Treatment with the aid of telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We assume a cohort out of the total of festival visitors which is composed of 16-40 years old people with occasional older visitors. The patient-collective can be composed of intoxications by alcohol or drugs and minor violations of the extremities. Effects of heat and light can occur as well. Only those who consent to our study can be part of it, therefore every patient has to give his or her consent to the evaluation of the already bespoken outcome measures and data acquisition.

You may qualify if:

• full legal age
• capacity to consent

You may not qualify if:

• apnea
• acute failure of breathing
• cardiac arrest
• STEMI
• unconsciousness
• status epilepticus
• life-threatening arrhythmia
• polytrauma
• non-manageable symptoms of a mental illness, self-endangerment, danger to others
• imminent birth
• serious traffic accident or traffic accident with children involved
• fall from a great height (\>3m)
• gunshot or knife wounds to the head, neck or torso
• fire with personal damage
• high-voltage accident

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Links

• project page with additional information presented for lay people

MeSH Terms

Interventions

Therapeutics

Study Officials

• Rolf Rossaint, Prof. Dr.

  University Hospital RWTH Aachen, Germany, Anaesthesiology Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master of Science, Scientific Staff

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 24, 2022
• Study Start: July 1, 2022
• Primary Completion: July 3, 2022
• Study Completion: June 6, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)