ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000022965

Ethics application status

Approved

Date submitted

20/12/2010

Date registered

7/01/2011

Date last updated

10/11/2021

Date data sharing statement initially provided

10/11/2021

Date results provided

10/11/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

The use of Near-Infrared Spectroscopy to assist in the diagnosis of Compartment Syndrome in paediatrics

Scientific title

The use of Near-Infrared Spectroscopy to assist in the diagnosis of Compartment Syndrome in paediatrics

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1113-2639

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

compartment syndrome

complications of fractures

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Observation of tissue oxygenation levels using near infrared spectroscopy.
Near infrared spectroscopy is a completely non-invasive optical method that utilizes near infrared light to ascertain the average oxygen saturation of haemoglobin in a region of tissue. The method is closely related to standard plethysmographic oxygen saturation measurement(SpO2), and is currently used in cardiac surgery to measure brain tissue oxygenation during cardiopulmonary bypass, and in intensive care. It is also used in sports science to study real-time muscle oxygen kinetics, and is being investigated in a variety of areas.
Group 1 involves patients presenting with grade 3 supracondylar fractures. NIRS monitoring of the injured and uninjured sides is commenced at the end of surgery for up to 48 hours or discharge, in addition to standard post operative monitoring(pain scores, range of motion, swelling).
Group 2 involves patients presenting with suspected compartment syndrome. In these patients a single discrete 2 minute NIRS measurement is made immediately prior to surgery, co-temporaneously with invasive compartment pressure measurement. At surgical fasciotomy, the muscle is assessed for signs of compartment syndrome(swelling, colour, response to stimulation)
The current planned duration is 1 year, with group 1 recruitment of 30 and group 2 recruitment of 10.

Intervention code [1]

Not applicable

Comparator / control treatment

clinical indicators of compartment sydnrome
compartment pressures. A standard assessment includes pain scores, range of motion, pain during active and passive movement, and manual assessment of muscle compartment swelling. Both NIRs and clinical indicators are used on all patients.
As mentioned above there are 2 groups, one with supracondylar fractures and the other with suspected compartment syndrome.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Tissue oxygenation level

Timepoint [1]

From time of operative fixation until hospital discharge in group 1, measured continuously at a 2 second sampling rate, for up to 48 hours or discharge.

At time of surgical intervention for fasciotomy for group 2, as a discrete measurement taken over 2 minutes at a 2 second sampling rate.

Secondary outcome [1]

number of group 1 patients developing compartment syndrome. Clinical assessment, described before, is used to detect the development of compartment sydnrome. If suspected, muscle compartment pressures are measured usign an invasive device(Stryker pressure monitor), and fasciotomy is performed, at which time the muscle is directly inspected for colour, swelling and response to stimulation, allowing a definitive diagnosis of compartment syndrome to be made.

Timepoint [1]

Continuous clinical observation for up to 48 hours post fixation or dischaege from hospital.

Eligibility

Key inclusion criteria

Grade 3 supracondylar fracture for group 1
Clinically suspected compartment syndrome for group 2

Minimum age

2 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

volar forearm skin damage preventing probe attachment
Jaundice

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/02/2010

Actual

26/02/2010

Date of last participant enrolment

Anticipated

Actual

30/11/2011

Date of last data collection

Anticipated

Actual

30/11/2011

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Children's Hospital at Westmead Volunteer fund

Address [1]

Hawkesbury road
Westmead
2145
NSW

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Children's Hospital at Westmead

Address

Hawkesbury Road
Westmead
2145
NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Children's Hospital at Westmead HREC

Ethics committee address [1]

Hawkesbury road
Westmead
2145
NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/02/2009

Ethics approval number [1]

08/CHW/117

Summary

Brief summary

Compartment syndrome occurs when swelling in a muscle interferes with the blood supply to that muscle. The syndrome happens most often in fractures, and after bone operations, and can lead to damage to the muscle and nerves of the limb affected. We are interested in using a new technology that is designed to look at the blood oxygen levels in tissue (in this case muscle). The technology uses probes attached to a machine. The probes are placed on the skin, and shine light into the muscle. The light is not damaging to the tissue. We would like to know more about the oxygen levels of muscles in compartment syndrome in children.
All children 0 to 18 years of age can participate. They cannot participate if they have jaundice, or broken skin where the probes may be placed. 
For those presenting with suspected compartment syndrome, when the child comes to theatre, once they are asleep, we will place a probe on the skin over the muscle. We will do this on the affected and the unaffected side. We will also do a standard compartment pressure measurement simultaneously. The probe will be left on for 2 minutes in theatre, and then removed. 
For those presenting with a supracondylar fracture, the probes will be placed on the injured, and uninjured sides and left on for 48 hours or until hospital discharge. 

The monitor has not yet been shown to help in this problem, and we will not use the values to alter treatment in any way. We hope that the results of this study will help us to detect compartment syndrome early on, and allow quicker treatment, in those children who develop it.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dr Justin Skowno

Address

Department of Anaesthesia, The Children's Hospital at Westmead, Hawkesbury Road, Westmead, 2145, New South Wales, Australia.

Country

Australia

Phone

+61298450000

Fax

justin.skowno@health.nsw.gov.au

Contact person for public queries

Name

Dr Justin Skowno

Address

Department of Paediatric Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145
NSW

Country

Australia

Phone

+61298450000

Fax

justins@chw.edu.au

Contact person for scientific queries

Name

Dr Justin Skowno

Address

Department of Paediatric Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145

Country

Australia

Phone

+61298450000

Fax

justins@chw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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