Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04725604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2020-12-16
Brief Title:
Real-time Soft Tissue Assessment Using a Technologically Advanced pH Monitoring System
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Real-time Soft Tissue Assessment Using a Technologically Advanced pH
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoftpH
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 participants 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
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 participants 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
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 flexionextension 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
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 flexionextension 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-NS-0005 | OTHER | Research Ethics Committee reference | None |