Mobile Stroke Unit for Pre-hospital Emergency Care

Not Applicable

• Conditions: Emergencies; Stroke, Acute
• Interventions: Other: Management

• Registration Number: NCT05330715
• Lead Sponsor: Daniel Phillips

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,

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Study First Submitted: 2022-03-03
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-10
• Last Update Submitted: 2022-04-10
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Primary Completion: 2023-09-29
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 836

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ambulance	Management	Prehospital emergency care with conventional ambulances.
Advanced Mobile Stroke Unit	Management	Prehospital treatment of patients with an advanced Mobile Stroke Unit. The advanced Mobile Stroke Unit is an ambulance equipped with a computed tomography scanner, and additional diagnostic devices, such as point-of-care-laboratory and telemedicine to enable the team to diagnose and initiated specialised treatment of emergency patients at the emergency site.

Primary Outcome Measures

Name	Time	Method
Number of patients requiring hospital attendance within 4h of acute emergency situation	acute emergency situation (4 hours)	Patient attendance at hospital related to the emergency call (within 4hours) will be assessed

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome on day 90	90 days	EQ-5D5L
Emergency management metrics	acute emergency situation (within 4 hours after call)	Time metrics related to the emergency call treatment (within 4 hours after call)

Trial Locations

Locations (1)

East of England Ambulance Service NHS Trust; 🇬🇧 Melbourn, United Kingdom