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Anatomy Guidance for Regional Anaesthesia

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ClinicalTrials.gov Identifier: NCT03647618
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Medaphor Limited

Brief Summary:

This mutlicentre study at three hospitals in south Wales, UK, will be used to determine if modern machine learning techniques can help the anaesthetist locate the target by highlighting key anatomical features on the ultrasound image in real time.

The study consists of two phases:

The objective of Phase I is to train a computer-aided system to identify target structures in regional anaesthesia when applied in the following categories:

  • Adductor canal
  • Popliteal
  • Fascia Iliaca
  • Rectus sheath
  • Axillary The objective of Phase II is to estimate the success rate and safety of the computer system being developed.

Condition or disease Intervention/treatment
Ultrasound Imaging Other: Ultrasound

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anatomy Guidance for Regional Anaesthesia
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Ultrasound

Group/Cohort Intervention/treatment
Adductor canal
Patients receiving ultrasound-guided regional anaesthesia
Other: Ultrasound
Ultrasound-guided regional anaesthesia

Popliteal
Patients receiving ultrasound-guided regional anaesthesia
Other: Ultrasound
Ultrasound-guided regional anaesthesia

Fascia Iliaca
Patients receiving ultrasound-guided regional anaesthesia
Other: Ultrasound
Ultrasound-guided regional anaesthesia

Rectus sheath
Patients receiving ultrasound-guided regional anaesthesia
Other: Ultrasound
Ultrasound-guided regional anaesthesia

Axillary
Patients receiving ultrasound-guided regional anaesthesia
Other: Ultrasound
Ultrasound-guided regional anaesthesia




Primary Outcome Measures :
  1. Phase 1 Outcome Measures: - Training/Verification • [ Time Frame: 3 months ]
    Development and verification of models that identify the target structures using a training dataset. Refinement of Phase II endpoint.

  2. Phase II Validation Outcome Measures - Validation [ Time Frame: 3 months ]

    • Validation of the models generated in Phase I using a validation dataset including:-

    • Estimation of performance and accuracy (e.g. success/failure of highlighting of target structures, average distance of highlighting from target, time spent highlighting correct structure as a proportion of time target visible)
    • Estimation of safety (e.g. instances where incorrect highlighting deemed unsafe)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Potential study participants will be identified from patients undergoing regional anaesthesia as part of their treatment at the three clinical centres involved, i.e. the Royal Gwent Hospital, Ystrad Mynach Hospital and St Woolos Hospital, Wales, UK.
Criteria

Inclusion Criteria:

  1. Male or female, at least 18 years of age;
  2. Undergoing regional anaesthesia as part of their treatment at the Royal Gwent Hospital, Ystrad Mynach Hospital and St Woolos Hospital, Wales, UK.
  3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

  1. Aged <18 years of age;
  2. Unwilling or unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647618


Contacts
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Contact: Nicholas Sleep, BSc MSc MBA +44 (0)2920 756534 nicholas.sleep@medaphor.com

Locations
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United Kingdom
St Woolos Hospital Recruiting
Newport, Wales, United Kingdom, NP20 4SZ
Principal Investigator: David Burckett-St.Laurent, MBBS FRCA         
Sponsors and Collaborators
Medaphor Limited

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Responsible Party: Medaphor Limited
ClinicalTrials.gov Identifier: NCT03647618     History of Changes
Other Study ID Numbers: ML2018_AG_02
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs