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

December 12, 2023 updated by: University of Aberdeen

Real-time Soft Tissue Assessment Using a Technologically Advanced pH

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who are admitted to an orthopaedic trauma unit or intensive care unit with fractures or crush injuries and who are at risk of developing Acute Compartment Syndrome (ACS) are eligible for the study.

These patients will undergo routine monitoring for signs and symptoms of ACS. Patients who are able to make decisions about the ongoing treatment of their injured limb will be approached about the study. The patient will initially be given a short verbal statement about the study. At this point, patients may agree to take part or request additional information about the study. If patients request additional information, they can be offered a brief Patient Information Leaflet (PIL) or more detailed PIL. After reading this, they may agree to take part. Patients who agree to take part can either give verbal agreement to take part at this stage, or written informed consent.

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 participants 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.

Once patients start to recover, written informed consent will be sought from those participants who gave verbal agreement at the outset of their participation in the study.

Until their discharge from hospital, clinical information will be collected from their medical notes or collected directly onto the study case report forms. Information from the pH monitor will be downloaded into the study website.

Participants will usually be followed up as part of routine care approximately 6 months after their initial injury. Where possible, the study follow-up will coincide with this routine follow-up. The study follow-up will include clinical examination of the limb that sustained the initial injury (including any evidence of contracture, strength of flexion/extension and any sensory abnormalities). At the 6 month follow-up participants will also be asked to complete a quality of life questionnaire.

The primary objective is to establish that the Softcell pH monitoring system measures muscle pH in an injured limb over time, monitoring changes in muscle pH that are consistent with ischaemia (drops in pH).

The properties of the pH probe as a diagnositic test will be investigated. The first analysis will be carried out after recruitment is complete, and initial data (up to 72 hours monitoring for ACS, and to potential discharge) is available. For this analysis, the presence of disease will be defined as fasciotomy within 72 hours.

A second analysis will be undertaken at the end of the study after the 6 month patient reviews have been undertaken. For this analysis, the presence of disease will be defined as fasciotomy within 72 hours OR evidence of contracture at 6 months OR significant reduction in strength OR significant sensory loss which is not improving by six months that anatomically suggest ACS.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospital Birmingham
        • Contact:
        • Principal Investigator:
          • Ansar Mahmood
      • Dundee, United Kingdom, DD3 8EA
      • Edinburgh, United Kingdom, EH1 3EG
      • Glasgow, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary
        • Contact:
      • Glasgow, United Kingdom, G51 4TF
        • NHS Greater Galsgow and Clyde - Queen Elizabeth University Hospital
        • Contact:
      • Glasgow, United Kingdom, PA2 9PJ
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB15 6RE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Orthopaedic Limb injuries that are at increased risk of developing ACS. In particular the following injuries will have been sustained to permit inclusion:

    1. Tibial diaphyseal fractures
    2. 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).
    3. Forearm diaphyseal fractures
    4. High energy injuries around the elbow resulting in complex fracture dislocations.
    5. 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pH Probe
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-muscular pH
Time Frame: up to 72 hours
ph measured by Softcell device
up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-compartmental pressure
Time Frame: up to 72 hours
pressure as measured by standard clinical equipment
up to 72 hours
No of people with Acute Compartment Syndrome
Time Frame: Up to 72 hours
Standard clinical assessment for Acute Compartment Syndrome up to 72 hours
Up to 72 hours
No of people with Acute Compartment Syndrome
Time Frame: At 6 months
Standard clinical assessment for Acute Compartment Syndrome at 6 months
At 6 months
Generic Quality of Life
Time Frame: 6 months
EQ-5D-5L Scored -10 -100. (-10 being the worst health you can imagine and 100 being the best health you can imagine
6 months
Disease specific Quality of Life - Upper limb
Time Frame: 6 months
Disabilities of the Arm, Shoulder and Hand - Scored from 0 - 100 (0 = no disability , 100 = severely disabled)
6 months
Disease specific Quality of Life - Lower limb
Time Frame: 6 months
Short Musculoskeletal Function Assessment - Scored from 0 - 100 (o = no disability, 100 = severely disabled).
6 months
Number of participants with adverse events
Time Frame: Up to 144 hours
Standard clinical assessment for adverse events
Up to 144 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian
Softcell Medical Ltd

Investigators

  • Principal Investigator: Iain Stevenson, NHS Grampian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

July 28, 2025

Study Completion (Estimated)

July 28, 2025

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-061-18
  • 21-NS-0005 (Other Identifier: Research Ethics Committee reference)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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