Clinical trial NCT05330715: Mobile Stroke Unit for Pre-hospital Emergency Care
Official title: Advanced Mobile Stroke Unit for Pre-hospital Emergency Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Emergencies
Lead sponsor: East of England Ambulance Service NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Universität des Saarlandes
name: East Suffolk and North Essex NHS Foundation Trust
First posted: 2022-04-15
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Emergency department overcrowding is a major challenge in medicine, leading to a delay in diagnosis and treatment for the patient due to long waiting times. This is very relevant for diseases like acute stroke and other emergencies. The Advanced Mobile Stroke Unit is an ambulance equipped with additional devices to diagnose and treat patients at the emergency site. Patients with less severe conditions can be diagnosed and safely left at home. The objectives of this project are to investigate whether the Advanced Mobile Stroke Unit compared to a normal ambulance enables more accurate triage of patients (treatment at home vs hospital vs specialist vs A\&E). The Advanced Mobile Stroke Unit ambulance will be used in a random order of weeks and this will be compared to weeks with normal ambulances. The study will be carried out by the East of England Ambulance Service NHS Trust in collaboration with the East Suffolk and North Essex NHS Foundation Trust in the East of England. The project is a collaboration with Saarland University, Germany,


Eligibility criteria: Inclusion Criteria:

* acute emergency patients 18 years or older, who are identified via the national emergency telephone number 999 or 111with suspected severe medical emergency condition, which is categorised as: breathing problem, seizure, falls with head trauma, headache, sick person with suspected infection, stroke, unconsciousness
* calls Monday to Friday 9am to 5 pm
* written informed consent

Exclusion Criteria:

* terminally ill patients
* pregnant patients
* patients in cardiac arrest
* patients in custody of Her Majesty's prison service

Primary outcomes:
measure: Number of patients requiring hospital attendance within 4h of acute emergency situation
timeFrame: acute emergency situation (4 hours)
Secondary outcomes:
measure: Emergency management metrics
timeFrame: acute emergency situation (within 4 hours after call)
measure: Clinical Outcome on day 90
timeFrame: 90 days
measure: Clinical Outcome on day 90
timeFrame: 90 days
Other outcomes:
measure: Safety endpoints
timeFrame: 90 days
measure: Safety endpoints
timeFrame: 24 hours
measure: Safety endpoints
timeFrame: 90 days
measure: Health economic analysis
timeFrame: acute phase related to the emergency call (12 hours)
measure: Health economic analysis
timeFrame: 1 year after the acute emergency call
Locations:
city: Melbourn
country: United Kingdom
facility: East of England Ambulance Service NHS Trust
Study officials:
affiliation: Universität des Saarlandes, EEAST
name: Silke Walter, Prof
role: PRINCIPAL_INVESTIGATOR
References: