Feasibility of Telemedicine Under Ambulance Station Conditions

NCT ID: NCT05388071

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 404 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-06

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.

Detailed Description

To evaluate the feasibility of telemedicine in context of an ambulance station with all the given restrictions compared to usage of telemedicine in emergency medical services (EMS), we will set up each one ambulance station at four large-scale events in Germany with a telemedicine infrastructure. The ambulance stations at such events are the primary place to go for visitors to get a primary medical care and is also used as a primary place for the patients of medical service providers on feet.

As part of the telemedicine infrastructure, educated personnel is required. The study protocol defines that any medical personnel with the ability to use telemedicine must be declared as a "Rettungssanitäter/in", a special paramedic qualification in Germany comparable to an EMT-I/85 (Intermediate) in the USA. These emergency personnel are called "TeleSAN".

Before the assignment in the ambulance station starts, every TeleSAN will be educated and briefed in the usage of the telemedical devices. The used equipment has been evaluated in context of the research project "TeleSAN" at the AcuteCare InnovationHub, University Hospital Aachen, Germany and is composed of a smartphone with a TeleSAN-app, a headset, and a camera. In addition to that, every TeleSAN in the ambulance station will be equipped with a Bluetooth-medical-device-set consisting of a mini-ECG, a blood glucose meter, a blood pressure cuff and a bluetooth-stethoscope which can stream all data in real-time to the tele-EMS-physician.

To stream the data and as a communication platform, the "TeleDoc"-App for video-consultation and the "TeleSAN"-App which is based on the "TeleDoc"-App with a focus on disaster medicine, both developed by Docs in Clouds TeleCare GmbH, Aachen, Germany, will be used.

Every patient who enters the ambulance station will be informed that a telemedicine-study is going on. In addition to that, the protocol defines a separate enlightenment for every patient who will be treated by telemedicine through the TeleSAN-operator before the teleconsultation starts.

Whether telemedicine will be used for patient's treatment or not is at the discretion of the TeleSAN, who will always start the treatment on his / her own and evaluates if the patient meets any exclusion criteria which would lead to not-usage of telemedicine.

In case of a none-given consent or in case of medical or technical necessity of termination of the teleconsultation, the tele-EMS-physician can work as a regular EMS-physician in the ambulance station thanks to spatial proximity. Therefore, we can guarantee a treatment according to the current medical standards all the time. In addition to the already listed medical devices, we will also have a defibrillator/ECG-monitor, a ventilator and a suction pump available for emergency situations.

The aim is to evaluate if telemedicine is feasible in context of an ambulance station regarding medical protocols, observations, and surveys.

In a further step an assessment of a possible usage of telemedicine in context of civil defense situations will be done.

Conditions

Telemedicine; Disaster Medicine; Emergency Medicine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Usage of telemedicine and tele-consultation for treatment

Intervention Type: 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.

No intervention: Usual treatment

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

No interventions assigned to this group

Interventions

Usage of telemedicine and tele-consultation for treatment

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

• full legal age
• capacity to consent

Exclusion Criteria

• 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
• water accidents (drowning, swimming accidents, breaking in the ice)
• accidents with involvement of hazardous substances
• killing spree, hostage situations or other situations which endanger the lives of the medical personnel
• imminent threat of suizide
• non-consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Anna Müller

Principal Investigator, Master of Science, Scientific Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolf Rossaint, Prof. Dr.

Role: STUDY_CHAIR

University Hospital RWTH Aachen, Germany, Anaesthesiology Clinic

Locations

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Related Links

https://telesan.de

project page with additional information presented for lay people

Other Identifiers

Notice No. 03/2019

Identifier Type: OTHER

Identifier Source: secondary_id

22-130

Identifier Type: -

Identifier Source: org_study_id