Real-time Soft Tissue Assessment Using a Technologically Advanced pH Monitoring System

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 crush 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 - currently clinical assessment and pressure probes are used to assess 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.

In this study, the investigators will use a pH probe to measure muscle pH, and in particular, any build-up of acid caused by reduced blood flow in the injured limb. The investigators will compare the pH probe values with the existing methods for diagnosing ACS.

Patients with a fracture or crush injury who are risk of developing ACS will be recruited into the study. Participants 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 participants in the study will be made using the existing methods and not based on information from the pH 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. The Soft pH trial team will compare how well the pH probe performs in diagnosing ACS compared to the existing methods. The investigators will follow participants up at 6 months after their initial injury to identify missed ACS cases based on clinical findings.

Diagnosing ACS earlier may reduce the likelihood of long-term symptoms and loss of function that is often seen in cases of ACS.

Conditions

• Acute Compartment Syndrome

Interventions

DEVICE

pH probe

Patients who agree to take part will have a pH probe inserted into their injured limb. The pH probe will be attached to a pH monitor which will record pH data for up to a maximum of 72 hours (24 hours per probe). The surgical team will not have access to the pH data. During the time they are considered "at risk" for ACS, patients will be monitored in the routine way (using regular clinical assessment and pressure monitoring). If ACS is diagnosed in the routine way, then treatment (fasciotomy) will be offered as appropriate.

Sponsors & Collaborators

• NHS Grampian

  collaborator OTHER_GOV

• Softcell Medical Ltd

  collaborator UNKNOWN

• University of Aberdeen

  lead OTHER

Principal Investigators

• Iain Stevenson · NHS Grampian

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2025-07-28

Completion

2025-07-28

Countries

• United Kingdom

Study Locations