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Effect of intermittent pneumatic compression on muscle tissue oxygenation: a randomised cross-over controlled volunteer study

Effect of intermittent pneumatic compression on muscle tissue oxygenation: a randomised cross-over controlled volunteer study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000710224
Enrollment
20
Registered
2018-05-01
Start date
2018-04-12
Completion date
2018-04-23
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Dete

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.

Sponsors

Royal Perth Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026