Mobile Stroke Unit for Pre-hospital Emergency Care

NCT05330715 | Unknown

• 1 other identifier: 292195
• Study Type: interventional
• Target: 836
• Locations: 1 country
• Sites: 1

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,

Conditions

Stroke, Acute; Emergencies

Outcome Measures

Primary Outcomes (1)

• Number of patients requiring hospital attendance within 4h of acute emergency situation

  Patient attendance at hospital related to the emergency call (within 4hours) will be assessed

  acute emergency situation (4 hours)

Secondary Outcomes (3)

• Emergency management metrics

  acute emergency situation (within 4 hours after call)

• Clinical Outcome on day 90

  90 days

• Clinical Outcome on day 90

  90 days

Other Outcomes (5)

• Safety endpoints

  90 days

• Safety endpoints

  24 hours

• Safety endpoints

  90 days

Study Arms (2)

Advanced Mobile Stroke Unit

OTHER

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.

Other: Management

Conventional ambulance

OTHER

Prehospital emergency care with conventional ambulances.

Other: Management

Interventions

Management OTHER

Comparison if different strategies to manage acute emergencies in the pre-hospital setting.

Advanced Mobile Stroke Unit; Conventional ambulance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Daniel Phillips: lead
• Universität des Saarlandes: collaborator
• East Suffolk and North Essex NHS Foundation Trust: collaborator

Study Sites (1)

East of England Ambulance Service NHS Trust

Melbourn, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Emergencies

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silke Walter, Prof

  Universität des Saarlandes, EEAST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Phillips

CONTACT

+447971059148; daniel.phillips@eastamb.nhs.uk

Klaus Fassbender, Prof

CONTACT

+4968411624103; klaus.fassbender@uks.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Lead

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 15, 2022
• Study Start: March 29, 2021
• Primary Completion: September 29, 2023
• Study Completion: March 31, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

GB (1)