Chemical Analysis of Limb Microfluidics

NCT06050499 | Unknown

• 2 other identifiers: 20SM5770IRAS
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Compartment syndrome (CS) is a condition where an increase in pressure in an anatomical compartment (e.g. the lower leg) affects the blood supply of the tissues, leading to tissue damage. The condition is difficult to diagnose, and more difficult to determine when and how to manage it. Treatment aims to reduce the pressure in the compartment by whatever means possible. Surgical management by of CS is highly invasive and has associated risks including infection, damage to local structures (i.e. nerves), and possibly the inability to close the wound leading to the need for further reconstructive procedures. The clinical challenge in suspected CS is knowing if and when to intervene. Some cases of mild CS may resolve without an operation, and therefore intervening too soon causes unnecessary harm to the patient. However, waiting too long to operate with high compartmental pressures may lead to irreversible damage to the tissues, resulting in either a useless limb or necrotic tissue needing amputation. Current strategies for determining limb health include interrogation of symptoms, signs on examination, and serial measurements of compartmental pressures, but no absolute measurement of tissue health. As such, there is an element of clinical judgment in management and no evidence base with which to develop clear treatment guidelines. There is a need for a minimally invasive method of continuously monitoring tissue health to improve the understanding of CS and its management before significant improvement in patient outcomes can be delivered. It is proposed the application of leg "microfluidics" - analysis of samples of leg fluid - in a series of predictable clinical scenarios which simulate the threatened and unsalvageable limb. This is with an ultimate aim of developing a method of limb fluid sampling that can predict if CS is present and requires intervention.

Conditions

Limb Ischemia; Compartment Syndrome of Leg

Keywords

Microfluidics; Compartment syndrome; Limb ischaemia

Outcome Measures

Primary Outcomes (1)

• Relative concentrations of key metabolites

  Relative concentrations of key metabolites (glucose, potassium, lactate) in lower limb interstitial fluid, estimated against baseline

  20 minutes (real time analysis that takes 20 minutes to register from point of sampling to result)

Study Arms (2)

Irreversible ischaemia

patients undergoing elective amputation of a limb (e.g. peripheral vascular disease)

Device: Microdialysis catheter + biosensor

Reversible ischaemia

patients undergoing an operation with a limb tourniquet or intentional controlled reduction in blood flow to the lower limb (e.g. aortic cross clamping for vascular surgery).

Interventions

Microdialysis catheter + biosensor DEVICE

Microdialysis catheter from linton instrumetal "63 MD Catheter"

Irreversible ischaemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (aged greater than or equal to 18 years) who are either: i. Undergoing an intervention where there is a controlled reduction in blood flow to the limb that is reversible (e.g. using a tourniquet or clamp) or irreversible (e.g. during limb amputation). ii. At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.

You may qualify if:

• Adult patients (aged greater than or equal to 18 years) who are either:
• i. Undergoing an intervention where there is a controlled reduction in blood flow to the limb that is reversible (e.g. using a tourniquet or clamp) or irreversible (e.g. during limb amputation).
• ii. At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.

You may not qualify if:

• Age \<18 years old Unable to provide informed consent

Sponsors & Collaborators

• Imperial College London: lead
• The Drummond Foundation (RAMC charity): collaborator

Study Sites (1)

Imperial College London

London, W21NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Compartment Syndromes

Interventions

Biosensing Techniques

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Probe Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)