Telemedical Support for Prehospital Emergency Medical Service
- Conditions
- Emergency
- Interventions
- Other: tele-EMS physicianOther: conventional EMS physician
- Registration Number
- NCT02617875
- Lead Sponsor
- RWTH Aachen University
- Brief Summary
The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS physician) uses software-based guideline conform algorithms for diagnosis and treatment.
At the prehospital emergency scene half of the patients will receive this telemedicine-based approach and the other half the conventional emergency physician-based care.
- Detailed Description
The usual Emergency Medical Services (EMS) in Germany consists of a dual system with two paramedics and one EMS physician on scene.
Telemedicine networks between medical personnel and medical experts were shown to be beneficial for the quality of health care in many medical fields. The investigators have developed a holistic multifunctional mobile EMS teleconsultation system, as a complementary structural element to the ground based and air based EMS. This tele emergency system was evaluated and implemented during two third-party funded telemedicine projects (Med-on-@ix and TemRas) in the city of Aachen, Germany.
The EMS teleconsultation system was step-wise introduced in the clinical routine of Aachen. Several cases (hypertensive emergency cases, stroke, dislocated fractures etc.) with the primary indication for an EMS physician are already dispatched solely to the paramedics, who can demand support by a tele-EMS physician at any time.
Our aim is to demonstrate that the tele-EMS system is non-inferior in comparison to the conventional german EMS physician system with respect to safety. Moreover, the investigators want to evaluate which system provides a better quality with respect to recording important aspects of medical history and a more guideline conform treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3534
- All non-life-threatening emergency calls, which do not obligatory require an EMS physician on scene and which do not solely require an ambulance vehicle staffed with paramedics. study.
-
All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:
-
Patient condition related indications:
- Apnea
- Acute respiratory failure
- Cardiocirculatory arrest
- ST-elevation myocardial infarction (STEMI)
- Unconsciousness
- Persistent seizure
- Life- threatening rhythm disorder
- Major trauma
- Complex psychiatric disorders
- Age < 18 years
-
Emergency case related indications
- Major vehicle accident
- (Traffic) accident with children
- Fall from a height (> 3m)
- Gunshot-, stab-, or blow injuries in the head, neck and torso area
- Fires with reference to personal injury
- Carbon monoxide intoxication
- Explosion-, thermic or chemical accidents with reference to personal injury
- High-voltage electrical accident
- Water connected accidents (drowning-, diving accident, fall through ice)
- Entrapment or accidental spillage
- Hostage-taking, rampage or other crimes with potential danger for human life (preventive deployment, police consultation)
- Immediate threatening suicide
- Immediate forthcoming delivery or preceding delivery
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele-EMS physician tele-EMS physician The dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a tele-EMS physician, if this is the result of the randomization software. Conventional EMS physician conventional EMS physician The dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a conventional EMS physician, if this is the result of the randomization software.
- Primary Outcome Measures
Name Time Method Intervention-related adverse events 1 day * Allergic reaction to drug application due to incorrect survey of patients' medical history
* Intervention-related and immediate treatment requiring blood pressure drop
* Intervention-related apnea or respiratory insufficiency
* Intervention-related circulatory arrest
- Secondary Outcome Measures
Name Time Method Treatment associated quality indicator 1 day Quality of medical history survey (adherence to the guidelines).
Treatment quality 1 day Adherence to the guidelines
Quality of the EMS-case data documentation 1 day Completeness and correctness of the entered data in the standardized EMS documentation form/ the EMS documentation software.
Adherence to the guidelines for documentation in the EMS.Conversion of the initial dispatched tele-EMS treatment 1 day Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician
Death 30 days Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.
Duration of the physician engagement-time 1 day start: first contact time-point, end: termination of contact
Intensive Care Unit (ICU) length of stay 30 days start: ICU length of stay-end: ICU length of stay
Number of conventional EMS physician operations, which could be handled by a tele-EMS physician 1 day Number of patients
Fulfillment of predefined quality indicators for "Tracer" diagnoses 1 day Tracer diagnoses
* Stroke
* Acute coronary syndrome
* Pain therapyHospital length of stay 30 days start: Hospital length of stay-end: Hospital length of stay
Correct pre-hospital diagnosis 30 days Comparison to the hospital discharge diagnosis
Adverse events independently of the kind of EMS care 30 days The incidence of adverse events (AE) and serious adverse events (SAE)
Premature termination of the telemedical or conventional EMS operation 1 day Incidence of unnecessary EMS missions
Trial Locations
- Locations (1)
Department of Anesthesiology, University Hospital Aachen
🇩🇪Aachen, NRW, Germany