Title: A new neuromuscular, muscle pump stimulation device to improve haemodynamic stability in critical care patients
Funder: Department of Health (England)

Abstract: The work plan has three distinct phases: Phase 1: Design and manufacture of new OnPulse device Phase 2: Design and approval of testing protocol Phase 3: Implementation of testing Each Phase is comprised of individual work packages with associated deliverables, milestones and go/no go points: Phase 1: Work Package 1: Gathering information from key opinion leaders and end-users This WP is designed to elicit the opinions of researchers, clinicians and medical personnel who will use the device to ensure that a device that is fit for purpose is designed. WP1 will deliver a report summarising the outcomes of questionnaires and focus groups. Work Package 2: Design of device based upon WP1 This WP will use formal design protocols to produce a performance specification and technical specification. WP2 will deliver formal technical and performance specification documents Work Package 3: Manufacture of device based upon WP2 Work Package 3: Manufacture of device systems and integrated device This WP will ensure that the technical and performance specifications produced in WP2 are correctly implemented and that a device that is fit for purpose is manufactured in limited numbers. WP3 will deliver a minimum of 200 devices for testing purposes. Phase 2: Work Package 4: Design of experiments and regulatory approval This WP will recruit subjects in two groups: high risk and low risk to allow ensure that safe and ethical tests designs are produced that will also garner the data require to establish efficacy of the device. It will ensure that any effects observed are due to the predicted physiological effects induced by the device and not side effect or placebo. This will achieved by tests designed with the following parameters: 1) OnPulse off / Intermittent Pneumatic Compression on and OnPulse on / Intermittent Pneumatic Compression off. 2) Patients being mechanically ventilated (but not paralysed). 3) In both the crossover and the parallel design studies, the final ‘on’ and ‘off’ measurement periods will be after a dose of neuromuscular blocking drug has been administered. WP4 will deliver a formal test protocol that meets the necessary regulatory requirements. Phase 3: Work Package 5: Tests of device This WP will conduct tests to glean the data specified in the test protocol. The outline procedure in all tests will be: 1) Baseline measurement 2) Placement of OnPulse and remeasuring these parameters 3) Anaesthetising and application of study conditions. Crossover studies will be conducted of ‘high risk’ and ‘low risk’ (25 of each type)to establish the effect of the application and removal of stimulation between the two groups. A parallel, randomised, study of 75 ‘high risk’ patients (3 groups of 25) will be conducted to determine effects of device using standard Intermittent Pneumatic Cuff (IPC) as a control: OnPulse switched on and IPC applied but not switched on, or , OnPulse applied but not switched on and IPC applied and switched on, or , OnPulse applied to the upper arm and switched on and IPC applied but not switched on. Milestones / Go/no go points The following milestones have been set as stage gates or go/no go points for the project. Milestone 1: Expert feedback delivered: Milestone 2: Device design achieved: Milestone 3: Ethics approval and/or MHRA non-objection: Milestone 4: Successful test of simple prototype: Milestone 5: Completion of device trials: The timing of this plan and resourcing is described in detail in the relevant sections.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR