Chemical Analysis of Limb Microfluidics

NCT ID: NCT06050499

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Irreversible ischaemia

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

Microdialysis catheter + biosensor

Intervention Type: DEVICE

Microdialysis catheter from linton instrumetal "63 MD Catheter"

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).

No interventions assigned to this group

Interventions

Microdialysis catheter + biosensor

Microdialysis catheter from linton instrumetal "63 MD Catheter"

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Age <18 years old Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Drummond Foundation (RAMC charity)

UNKNOWN

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Madelaine Gimzewska, MBChB

Role: primary

m.gimzewska@imperial.ac.uk

+442075948904

Other Identifiers

IRAS

Identifier Type: OTHER

Identifier Source: secondary_id

20SM5770

Identifier Type: -

Identifier Source: org_study_id