Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000710224
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
1/05/2018
Date last updated
13/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of intermittent pneumatic compression on muscle tissue oxygenation: a randomised cross-over controlled volunteer study
Scientific title
Effect of intermittent pneumatic compression on muscle tissue oxygenation: a randomised cross-over controlled volunteer study
Secondary ID [1] 294714 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thromboembolism 307586 0
Tissue perfusion 307587 0
Condition category
Condition code
Blood 306650 306650 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty volunteers are randomised to have their left or right arm treated with a sequential or single-compartment IPC for 10 minutes, using the contralateral arm without IPC as an intra-participant control. After a 5-min wash-out period, the procedure is repeated on the same arm using the alternative mode of IPC. IPC will be applied on by the investigators. IPC devices: The Kendall device and sleeves used for this study were provided by Cardinal Health® and the device uses a “Vascular Refill Detection” method to customise the therapy for each patient’s physiology. This system measures the time it takes for the veins in the limb to refill after having been compressed by the system. The time is then used in subsequent cycles as the time between compressions. Vascular Refill Detection occurs automatically and requires no operator interaction. The pressure inflated to the limb compression sleeves is 30-45mmHg and the inflation time is 12sec. Flowtron Universal (Huntleigh Healthcare, Manalapan, NJ, USA) is used as the intermittent pneumatic single-compartment compression which has a 12sec inflated and 48sec deflated time with an inflation pressure of 40mmHg.
Intervention code [1] 301008 0
Prevention
Comparator / control treatment
No Intermittent Pneumatic Compression (IPC) applied to the non-treatment arm of the same participants
Control group
Active

Outcomes
Primary outcome [1] 305650 0
Thenar muscle tissue oxygenation is the primary outcome. We use the InSpectraTM tissue spectrometer (Hutchinson technology, Hutchinson, MN, USA) to measure the hand thenar muscle tissue oxygenation (StO2). This device is a novel non-invasive haemodynamic monitor. It utilises near infra-red spectroscopy (NIRS) technology to measure the proportion of oxygenated haemoglobin relative to total haemoglobin level in the tissue by applying a 15-mm probe, similar to an ordinary pulse oximeter probe, to thenar muscles of the hand. The device can provide continuous real-time peripheral muscle tissue oxygenation (StO2) data.
Timepoint [1] 305650 0
StO2 monitored every 2-min for 10 minutes with each mode of IPC compressions. The details of the procedures are as follows:
After standard calibration and the InSpectraTM StO2 probe will be positioned to achieve the maximum tissue haemoglobin index (THI: a measurement reflects the haemoglobin signal strength in the region of the microvascular sensed by the probe; >10 is the acceptable signal), the StO2 of the thenar muscles in both hands (with and without IPC compressions) of the participants in an upright sitting position is monitored every 2-min for 10 minutes. Participants are randomised to have their left or right arm to have the IPC and also randomized to either the sequential or single-compartment IPC first. The contralateral arm without IPC is used as an intra-participant control. After a 5-min wash-out period, the procedure is repeated on the same arm using the alternative mode of IPC.
Secondary outcome [1] 346043 0
NIL
Timepoint [1] 346043 0
NA

Eligibility
Key inclusion criteria
20 adult volunteers with age more than 18 years old who are healthy or those with underlying cardiopulmonary, neurological or mild peripheral vascular diseases will be recruited.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers with severe underlying coagulation derangement who may develop bruises easily with pneumatic compression or those with upper limb neuropathic pain are excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered sealed envelopes,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures of ANOVA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/04/2018
Date of last participant enrolment
Anticipated
Actual
23/04/2018
Date of last data collection
Anticipated
14/05/2018
Actual
12/05/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10785 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 22524 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 299320 0
Hospital
Name [1] 299320 0
Royal Perth Hospital
Country [1] 299320 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 298589 0
None
Name [1] 298589 0
Address [1] 298589 0
Country [1] 298589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300228 0
Royal Perth Hospital
Ethics committee address [1] 300228 0
Royal Perth Hospital, Wellington Street, Perth, WA 6000
Ethics committee country [1] 300228 0
Australia
Date submitted for ethics approval [1] 300228 0
14/11/2017
Approval date [1] 300228 0
02/01/2018
Ethics approval number [1] 300228 0
RGS0000000641

Summary
Brief summary
Intermittent pneumatic compression (IPC) has been widely used as a means to prevent venous thromboembolism in hospitalised patients. Whether IPC should be considered different from thromboembolic deterrent stockings and is not contraindicated in patients with peripheral-limb vascular insufficiency is uncertain. This study assesses whether (1) IPC can improve peripheral-limb muscle tissue oxygenation (StO2), and (2) a sequential-compressions mode is better than a single-compartment compression in improving StO2. Twenty volunteers will be randomised to have their left or right arm treated with a sequential or single-compartment IPC for 10 minutes, using the contralateral arm without IPC as an intra-participant control. After a 5-min wash-out period, the procedure is repeated on the same arm using the alternative mode of IPC. StO2 on the hand thenar muscle is monitored every 2-min for 10-min using a near infra-red spectroscopy tissue oxygen saturation monitor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82982 0
Dr Kwok Ming Ho
Address 82982 0
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country 82982 0
Australia
Phone 82982 0
+61 8 92241056
Fax 82982 0
Email 82982 0
[email protected]
Contact person for public queries
Name 82983 0
Dr Kwok Ming Ho
Address 82983 0
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country 82983 0
Australia
Phone 82983 0
+61 8 92241056
Fax 82983 0
Email 82983 0
[email protected]
Contact person for scientific queries
Name 82984 0
Dr Kwok Ming Ho
Address 82984 0
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country 82984 0
Australia
Phone 82984 0
+61 8 92241056
Fax 82984 0
Email 82984 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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