Soft pH Study

  • Research type

    Research Study

  • Full title

    Real-time soft tissue assessment using a technologically advanced pH monitoring system

  • IRAS ID

    246315

  • Contact name

    Iain Stevenson

  • Contact email

    iain.stevenson@nhs.scot

  • Sponsor organisation

    University of Aberdeen

  • Clinicaltrials.gov Identifier

    NCT04725604

  • Duration of Study in the UK

    1 years, 4 months, 28 days

  • Research summary

    Acute Compartment Syndrome (ACS) can occur when there is a gradual reduction in the blood supply to injured limbs, most commonly after fractures or crushing injuries. If ACS is not diagnosed early enough, it can result in muscle and other tissues dying off because of the lack of blood supply. Diagnosing ACS remains a challenge for doctors and surgeons - currently clinical assessment and pressure probes are used for patients at risk of ACS. Previous research has shown that measuring pH in injured muscles is promising in diagnosing ACS and may help doctors diagnose ACS earlier than they can using current methods. \n\nIn this study, we will use a pH probe to measure pH, and in particular, any build-up of acid caused by reduced blood flow in the injured limb. We will compare the pH probe values with the existing methods of diagnosing ACS. \n\nPatients with a fracture or crush injury who are at risk of developing ACS will be recruited into the study. They will have a pH probe inserted into tissue close to their injury and pH data will be logged for up to 72 hours. Diagnosis and any treatment decisions for patients in the study will be made using the existing methods and not based on information from the probe (the team treating the patient will not have access to the pH data). Data on diagnosis and any treatment given for ACS will be collected from participant’s medical notes. We will compare how well the pH probe performs in diagnosing ACS compared to the existing methods. We will follow patients up at 6 months after their initial injury to identify missed ACS cases. \n\nDiagnosing ACS earlier may reduce the likelihood of long-term symptoms and loss of function that is often seen in cases of ACS.\n

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference

    21/NS/0005

  • Date of REC Opinion

    29 Jan 2021

  • REC opinion

    Favourable Opinion