Trial Review

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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 information initially 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] 253316 0
nil
Universal Trial Number (UTN)
U1111-1113-2639
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
compartment syndrome 258851 0
complications of fractures 258852 0
Condition category
Condition code
Musculoskeletal 258991 258991 0 0
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] 257770 0
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] 259842 0
Tissue oxygenation level
Timepoint [1] 259842 0
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] 268702 0
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] 268702 0
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?
No
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
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 258235 0
Hospital
Name [1] 258235 0
Children's Hospital at Westmead Volunteer fund
Country [1] 258235 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Hawkesbury Road
Westmead
2145
NSW
Country
Australia
Secondary sponsor category [1] 257402 0
None
Name [1] 257402 0
Address [1] 257402 0
Country [1] 257402 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260216 0
The Children's Hospital at Westmead HREC
Ethics committee address [1] 260216 0
Hawkesbury road
Westmead
2145
NSW
Ethics committee country [1] 260216 0
Australia
Date submitted for ethics approval [1] 260216 0
Approval date [1] 260216 0
26/02/2009
Ethics approval number [1] 260216 0
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 30690 0
Dr Dr Justin Skowno
Address 30690 0
Department of Anaesthesia, The Children's Hospital at Westmead, Hawkesbury Road, Westmead, 2145, New South Wales, Australia.
Country 30690 0
Australia
Phone 30690 0
+61298450000
Fax 30690 0
Email 30690 0
[email protected]
Contact person for public queries
Name 13937 0
Dr Dr Justin Skowno
Address 13937 0
Department of Paediatric Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145
NSW
Country 13937 0
Australia
Phone 13937 0
+61298450000
Fax 13937 0
Email 13937 0
[email protected]
Contact person for scientific queries
Name 4865 0
Dr Dr Justin Skowno
Address 4865 0
Department of Paediatric Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
2145
Country 4865 0
Australia
Phone 4865 0
+61298450000
Fax 4865 0
Email 4865 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 1.Skowno, J. J. et al. Near-infrared spectrosc... [More Details]

Documents added automatically
No additional documents have been identified.