SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies

NCT03323229 | Completed DMC

• 1 other identifier: 2-060-17
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief Summary

SatCare is a randomised controlled trial involving rapid standardised ultrasound assessment of patients with shock, major trauma, abdominal pain, chest pain or breathlessness in emergency ambulances. The scans will take less than 5 minutes and be transmitted to a hospital-based expert for review, providing support and instructions for optimal prehospital care. Five Highland Scottish Ambulance Service ambulances covering areas more than 30 minutes from Raigmore Hospital, Inverness, UK, will be equipped with an ultrasound machine (M-Turbo, FujiFilm Sonosite) and satellite transmission system plus webcam, and will be deployed in real emergency situations. When dispatched to a potentially eligible patient, the attending paramedic will contact Raigmore Hospital's emergency department to check the availability of an emergency medicine specialist and obtain study group allocation (ultrasound with enhanced telecommunications plus usual care versus usual care alone). Following verbal consent from the patient, trained paramedics will perform the condition-specific scan protocol in the ambulance at the incident site, and transmit the recordings and patient video via satellite to the emergency department for specialist analysis. The consultant will give advice on patient management via standard ambulance communications systems while it is en route to the hospital. The remotely supported prehospital ultrasound implementation will be examined in terms of its delivery and functioning. An economic evaluation will compare its use with care as usual for eligible patients transported by ambulance, modelling the costs and benefits of this service expansion and determining optimum use. It is hoped that the results, anticipated to be available in 2019, will provide an evidence base for the use of prehospital ultrasound for emergency care.

Conditions

Emergency Medical Services; Emergency Service, Hospital

Keywords

Ultrasonography; Ambulances; Satellite Communications; Telemedicine

Outcome Measures

Primary Outcomes (1)

• EQ-5D-5L (EuroQol five dimension, five level) score three months after the initial ambulance episode

  The EQ-5D-5L questionnaire includes assessments of mobility, self-care, daily activities undertaken, pain, discomfort, anxiety and depression.Completion of the EQ-5D-5L leads to the establishment of 243 distinct states, each with corresponding numerical quality of life value.

  3 months post recruitment

Secondary Outcomes (10)

• Cost per QALY (Quality Adjusted Life Year)

  3 months post recruitment

• Time from ambulance arrival at scene to definitive treatment or discharge

  up to 3 months post recruitment

• Mortality rate

  up to 3 months post recruitment

• Process evaluation (to investigate intervention use, acceptance and optimisation)

  15 months

• Costs to the NHS

  15 months

Study Arms (2)

Usual care (control group)

NO INTERVENTION

Patient receives care as usual.

Enhanced communications & ultrasound

EXPERIMENTAL

The paramedic will record a brief video summary of the patient's condition, then remotely supported point of care ultrasound scans will be performed, and both file types sent to the hospital for review and feedback from the consultant.

Diagnostic Test: Enhanced communications & ultrasound

Interventions

Enhanced communications & ultrasound DIAGNOSTIC_TEST

Paramedics will perform standardised point-of-care ultrasound scan protocols (specific to the patient's symptom set) and record a short (\<1 minute) video summarising the patient's condition and current management. These will be transmitted via satellite to consultants at the receiving hospital before the ambulance leaves the incident scene. The emergency department consultants will provide support and advice on continuing patient management via standard ambulance communications systems while it is en route to the hospital.

Enhanced communications & ultrasound

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with:
• significant trauma: any case where the mechanism of injury, anatomical defect or physiological upset triggers the paramedic to pre-alert a 'trauma call' to the receiving Emergency Department
• chest pain: pain felt below the clavicles and above the costal margin, whether anterior or posterior
• shortness of breath: any patient complaining of 'shortness of breath' or with paramedic examination positive for 'respiratory distress' whether by increased respiratory rate, effort or both
• abdominal pain: any pain felt below the costal margin and above the bony pelvis
• cardiovascular shock of unknown origin: either a systolic blood pressure below 100 mmHg or any symptoms or signs of syncope on elevation of the head, cool peripheries or extended capillary refill time
• Attended by a study ambulance
• Recruitment occurs within the hours supported by the Emergency Department: Monday to Friday, 09:00 to 17:00

You may not qualify if:

• Non-emergency ambulance transfers
• General practitioner requested emergency ambulances
• Patients under arrest or held in prison
• No potential value in performing ultrasound (e.g., none of the diagnoses listed above)
• Lack of consent for scan (if in intervention arm)
• Lack of capacity to consent to scan / no patient representative to provide consent
• Evidence of any condition leading to lack of capacity to give informed consent prior to the commencement of the study, as documented on the patient's electronic patient record
• Non-English speakers
• Outside the emergency department supported hours (Monday to Friday, 09:00 to 17:00)
• Paramedic decision to exclude patient, for reasons such as urgency of transport (i.e., where thorough on-scene evaluation would not normally be offered) or other lack of suitability

Sponsors & Collaborators

• University of Aberdeen: lead
• Scottish Ambulance Service: collaborator
• NHS Highland: collaborator

Study Sites (3)

Centre for Rural Health

Inverness, Scotland, IV2 3JH, United Kingdom

Location

NHS Highland: Raigmore Hospital

Inverness, Scotland, United Kingdom

Location

Scottish Ambulance Service

Inverness, Scotland, United Kingdom

Location

Related Publications (1)

• Eadie L, Mulhern J, Regan L, Mort A, Shannon H, Macaden A, Wilson P. Remotely supported prehospital ultrasound: A feasibility study of real-time image transmission and expert guidance to aid diagnosis in remote and rural communities. J Telemed Telecare. 2018 Oct;24(9):616-622. doi: 10.1177/1357633X17731444. Epub 2017 Sep 18.

  PMID: 28920524 BACKGROUND

Related Links

• European Space Agency project website
• University of Aberdeen project website

MeSH Terms

Conditions

Emergencies

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Leila Eadie

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

• Philip Wilson

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 26, 2017
• Study Start: December 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: January 31, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)