None listed
Conditions
Brief summary
This study will provide valuable data on the safe and efficacious use of muscle stimulation therapies currently applied by physiotherapists to patients receiving lifesaving Extra Corporeal Membrane Oxygenation (ECMO) which provides external cardiac and respiratory support for patients. Patients receiving ECMO are critically unwell and their prolonged ICU stays are associated with major loss of muscle mass and strength, and also with impaired physical function. Previously published experience from The Prince Charles Hospital (TPCH) suggests that this same patient group maybe at increased risk of foot necrosis (tissue death) either as a result of their disease process or machine techniques from the ECMO. Muscle stimulation is currently utilised by physiotherapists in TPCH ICU in an attempt to preserve the muscle mass of critically ill immobilised patients. Its effects in patients receiving ECMO have not been investigated. Changes in regional blood flow are also associated with the application of muscle stimulation.This study will demonstrate if a beneficial improvement in foot blood flow occurs as a result of muscle stimulation application which may prevent the development of foot problems in patients undergoing rescue therapy via ECMO. It will also be used to guide future research studies, and potentially therapy at this and other centres.
Interventions
The study is a randomised, sham controlled, single blind, crossover trial.
Participants will be any patient aged greater than 18 years undergoing femoral cannulation Extra Corporeal Membrane Oxygenation (ECMO) who would normally receive muscle stimulation as part of their standard physiotherapy care in the Intensive Care Unit (ICU) of the study site.
The intervention will be a single 30 minute muscle stimulation session (versus a single 30 minute sham intervention where the muscle stimulator wi
The study is a randomised, sham controlled, single blind, crossover trial. Participants will be any patient aged greater than 18 years undergoing femoral cannulation Extra Corporeal Membrane Oxygenation (ECMO) who would normally receive muscle stimulation as part of their standard physiotherapy care in the Intensive Care Unit (ICU) of the study site. The intervention will be a single 30 minute muscle stimulation session (versus a single 30 minute sham intervention where the muscle stimulator will be attached to the patient but inactive) applied by a physiotherapist to the thigh muscles of the participants . Electrodes will be applied to the treatment limb using a standardised placement. The muscle stimulator unit (NeuroTrac Sports dual channel NMES unit - Verity Medical) with a user customisable output will produce a dual channel synchronised delivery of an asymmetrical rectangular biphasic waveform with zero DC current, applied with a ramp up time of 2 seconds and frequency (pulse rate) of 35-50 Hz. Pulse duration will be 450 microseconds, with a current delivery “on” time of 5 seconds and an “off” time of 10 seconds. Initial current intensity will be zero mA which will be titrated to a intensity sufficient to obtain a visible contraction of the thigh muscles and a palpable tensioning of the patellar ligament, if no contraction is obtained the amplitude will be adjusted to the maximum deliverable amplitude (up to 90 mA depending on skin resistance). The investigators will be present during the intervention and sham applications to ensure adherence. Tissue perfusion at the foot during both the intervention and sham treatments will then be measured noninvasively via a combination of imaging (Moor Instruments FLPI 2 laser speckle contrast blood flow imager)and non imaging (Perimed - Periflux System 5000 with PF 5010 Laser Doppler Perfusion Monitor unit) laser Doppler flowmetry, and trancutaneous oximetry.as measured by a Radiometer TCM4 monitor A 1/2 hour washout period will then occur before the crossover intervention.
Sponsors
Paul McCormack
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study participants will be any patient undergoing ECMO via femoral cannulation in the ICU of The Prince Charles Hospital who would normally receive muscle stimulation as part of their standard physiotherapy care and who do not meet any of the exclusion criteria.
Exclusion criteria
Patients for whom consent was unable to be obtained Male or female < 18 years old Inability to independently transfer from bed to chair at baseline before hospital admission Known primary systemic neuromuscular disease at ICU admission Known intracranial process associated with localised weakness e.g. cerebrovascular accident (CVA) at ICU admission End-stage malignancy Diseases with systemic vascular involvement Bone fractures or skin lesions / open wounds on the area to be treated Epilepsy Heavy ischemia of the area to be treated Patients with permanent pacemaker (PPM) / implantable cardioverter-defibrillator (ICD) Brain death Allergic reaction to the electrodes Significant lower limbs oedema Obesity (Body Mass Index > 35kg/m2) Cardiovascular instability as determined clinically by the treating therapist or medical staff If the patient is receiving neuromuscular blockers If the patient displayed clinical signs of treatment intolerance. For sedated and intubated patients; the level of tolerance will be estimated by assessing signs of distress (e.g. significant heart rate (HR) and blood pressure (BP) alterations and/or presence of grimacing) as well as regular skin checks
Outcome results
None listed