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

NCT04725604 | Unknown

• 2 other identifiers: 3-061-1821-NS-0005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Acute Compartment Syndrome; Fasciotomy

Outcome Measures

Primary Outcomes (1)

• Intra-muscular pH

  ph measured by Softcell device

  up to 72 hours

Secondary Outcomes (7)

• Intra-compartmental pressure

  up to 72 hours

• No of people with Acute Compartment Syndrome

  Up to 72 hours

• No of people with Acute Compartment Syndrome

  At 6 months

• Generic Quality of Life

  6 months

• Disease specific Quality of Life - Upper limb

  6 months

Study Arms (1)

pH Probe

EXPERIMENTAL

Softcell pH monitoring system: designed to measure intramuscular pH levels in patients with fracture or crush injuries sufficiently severe to be at risk of developing ACS.

Device: pH probe

Interventions

pH probe DEVICE

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.

pH Probe

Eligibility Criteria

• Age: 16 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Tibial diaphyseal fractures
• High energy injuries around the knee (such as dislocations of the knee, fracture dislocations of the knee or complex fractures involving the proximal tibia e.g. Shatzker IV - VI types).
• Forearm diaphyseal fractures
• High energy injuries around the elbow resulting in complex fracture dislocations.
• Significant crush injuries to the lower or upper limbs, including thigh, lower leg, upper arm and forearm, where compartment syndrome is suspected, in the presence or absence of a fracture.
• Male and female participants will be a minimum of sixteen years of age and under 60 years of age.
• Participants should be able to understand spoken and written English.
• Able and willing to give verbal agreement or informed consent to participate.

You may not qualify if:

• Patients who have evidence of previous ACS in the affected limb are not eligible.
• Patients who were, prior to injury, receiving anticoagulant therapy (with the exception of aspirin or other anti-platelet aggregation drugs) for pre-existing conditions should also be excluded from the study.
• Patients who have other illnesses/disease processes for whom the study could be detrimental will be excluded from the study (for example those with blood clotting disorders, current leukaemia, currently chemotherapy treatment, visible signs of peripheral vascular disease).
• Eligible patients will have recently sustained a serious injury - in these circumstances, pregnancy testing is challenging and not routinely done in clinical practice. We will exclude patients who declare that they are pregnant.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator
• Softcell Medical Ltd: collaborator

Study Sites (7)

NHS Grampian

Aberdeen, Aberdeen City, AB15 6RE, United Kingdom

Location

University Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

NHS Tayside

Dundee, DD3 8EA, United Kingdom

Location

NHS Lothian

Edinburgh, EH1 3EG, United Kingdom

Location

NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary

Glasgow, G12 0XH, United Kingdom

Location

NHS Greater Galsgow and Clyde - Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

NHS Greater Glasgow and Clyde - Royal Alexandra Hospital

Glasgow, PA2 9PJ, United Kingdom

Location

Study Officials

• Iain Stevenson

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Innes

CONTACT

01224438089; softph@abdn.ac.uk

Seonaidh Cotton

CONTACT

softph@abdn.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will take part in pH probe monitoring. Results from the monitoring system will not be available until results are reviewed. No clinical decisions will be made using the new pH probes.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded diagnostic field study

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 27, 2021
• Study Start: March 1, 2024
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)