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Abstract
Objectives To determine the likely enrolment rate of eligible participants into a randomised controlled trial (RCT) in which a within-cast intermittent pneumatic compression device using Jet Impulse Technology (IPC/JIT) is 1 of 3 possible interventions in a RCT for the prevention of venous thromboembolism (VTE) in the clinical setting of isolated lower limb cast immobilisation.
Design A prospective, open-label feasibility study of the IPC/JIT device placed within a lower limb cast.
Setting Wellington Regional Hospital Fracture Clinic.
Participants Individuals aged 18–70 who presented with a lower limb injury requiring a minimum of 4 weeks below-knee cast immobilisation.
Intervention Placement of an IPC/JIT device within lower limb cast.
Outcome measures The main outcome measure was the proportion of eligible participants who participated in the feasibility study. Secondary outcome measures included adherence to device usage throughout the study, ease of application of the device and adverse events potentially associated with its use.
Results The proportion of potentially eligible participants for the IPC/JIT device was only 7/142 (5%), 95% CI 2 to 9.9. Devices were used for a mean (range) of 4.1 (1.9 to 10.2) hours per day and none of 7 participants had adequate adherence to the device. 3 of the 7 participants suffered an adverse event, including 1 deep vein thrombosis, 2 dorsal foot ulcer and 1 skin maceration.
Conclusions A within-cast IPC/JIT device is unlikely to be a feasible randomisation arm for a RCT assessing possible interventions for the reduction of VTE risk in the clinical setting of lower limb injury requiring below knee cast immobilisation for a minimum of 4 weeks.
Trial registration number ANZCTR 12615000192583.
- VASCULAR MEDICINE
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Footnotes
Contributors RB, IB, MW, BDR, GK, NW and JC contributed to the study concept and design. IB, BDR, AS and SE were involved in the acquisition of data. RB and IB contributed to the drafting of the manuscript. All authors participated in the critical revision of the manuscript for important intellectual content. IB and MW performed the statistical analysis. All authors provided administrative, technical and material support. IB was responsible for the study supervision.
Funding The JIT devices were supplied by Dickson and Dickson Healthcare for the purposes of undertaking the study. The study was funded by the Health Research Council of New Zealand (HRC) through a feasibility grant (14/570), IB was funded through the Health Research Council of New Zealand (HRC) by way of a Clinical Training Fellowship to undertake a PhD (14/040), and the Medical Research Institute of New Zealand also receives funding from the HRC through the Independent Research Organisations Capability Fund (14/1002).
Disclaimer The funding parties had no involvement in the design or preparation of the study, collection, analysis and interpretation of the data, or the decision to submit for publication.
Competing interests None declared.
Ethics approval New Zealand Health and Disability Ethics Committees (14/STH/138/AM03).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Additional data can be accessed via the Dryad data repository at http://datadryad.org/ with the doi:10.5061/dryad.5ms8t.