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21 March 2013
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| [ Print-friendly version ] |
| E-Vent: Electrical muscle stimulation in mechanical Ventilation |
| ISRCTN | ISRCTN35179428 |
| DOI | 10.1186/ISRCTN35179428 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | E-Vent: Electrical muscle stimulation in mechanical Ventilation |
| Scientific title | The effects of electrical muscle stimulation on muscle mass, strength and function in patients receiving mechanical ventilation: a randomised controlled, single blind feasibility study |
| Acronym | E-Vent |
| Serial number at source | 12700 |
| Study hypothesis |
Muscle wasting is common in critically ill patients and many develop profound weakness which may continue long after they have left hospital. Wasting starts early after admission and may be rapid. Limited physiotherapy techniques can prevent it in the early stages of illness.
Electrical muscle stimulation (EMS) is a method of exercising muscles by passing electrical current through skin electrodes. It has been tested extensively on other patient groups and can prevent muscle wasting and improve strength. Some research has used EMS on intensive care unit (ICU) patients, but these studies are too small to make definite decisions about how it works and whether it should be used routinely. This study will test EMS in ICU patients, and measure whether it prevents muscle wasting, and improves strength and function. Patients admitted to the Bristol Royal Infirmary ICU will be recruited to this study, where the research team is experienced in conducting studies involving critically ill patients. Because ICU patients are often unconscious and unable to make decisions, their relatives will be asked about their likely wish to join this study. The research team will apply EMS to the arm and thigh muscles twice daily. One group of patients will receive EMS and usual rehabilitation, and a second group will receive usual rehabilitation and sham (dummy) EMS, which is set up in the same way but does not cause muscle contraction. Measurements of muscle thickness using ultrasound will be performed during the ICU stay and strength and function will be tested at ICU and hospital discharge. Blood tests will be taken to help understand how EMS affects the muscles. Participants will be sent a questionnaire 90 days after their ICU admission. This will help inform physiotherapists and ICU staff whether EMS should be used routinely in the UK and internationally. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12700 |
| Lay summary | Lay summary under review 3 |
| Ethics approval | NRES Committee South West – Frenchay, 25/06/2012, ref: 12/SW/1077 |
| Study design | Parallel group randomised sham controlled feasibility clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Critically ill patients receiving prolonged periods of mechanical ventilation |
| Participants - inclusion criteria |
1. The target population is critically ill patients expected to receive prolonged mechanical ventilation (MV)
2. 18 years or older, male and female 3. Expected to receive MV for > 72 hour |
| Participants - exclusion criteria |
1. Body mass index < 15 kg/m² or > 35kg/m²
2. Pre-existing neuromuscular conditions affecting peripheral nervous system 3. Pacemaker or implanted cardiac defibrillator 4. Skin lesions making electrode placement impossible 5. Current upper and/ or lower limb fractures 6. Current pregnancy 7. Unable to walk or perform transfers prior to acute illness 8. Chronic renal disease 9. Chronic liver failure (Child Pugh score >3) 10. Irreversible disease with < 6 months prognosis 11. Long term oral steroid use >10mg 12. Uncontrolled / difficult to control epilepsy |
| Anticipated start date | 01/10/2012 |
| Anticipated end date | 30/09/2013 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Planned Sample Size: 28; UK Sample Size: 28 |
| Interventions | Electrical muscle stimulation Twice daily 30 minute sessions of electrical muscle stimulation to biceps and quadriceps, for duration of critical care stay. |
| Primary outcome measure(s) | Ultrasound quadriceps muscle layer thickness; Timepoint(s): Baseline, study days 4,7 and every 3 days, ICU discharge, hospital discharge |
| Secondary outcome measure(s) |
1. US (composite score: mid thigh, forearm and upper arm; rectus femoris cross sectional area )
2. Manual muscle Testing individual and composite muscle strength scores 3. Handgrip strength 4. Hand held dynamometry limb muscle strength 5. Barthel Index (BI) physical function score 6. Six-minute walk test 7. SF-36 (v2) health related quality of life questionnaire 8. Surrogate muscle biomarkers (serum c-reactive protein (CRP), plasma creatine kinase (PCK), plasma 3 methyl histidine (P3-MH), urinary creatine kinase (UCK) and 3 methyl histidine (U3- MH) 9. MV days 10. ICU, hospital and 90 day mortality 11. ICU and hospital length of stay (LOS) 12. Hospital resource use at discharge |
| Sources of funding | Intensive Care Foundation UK (UK) |
| Trial website | |
| Publications | |
| Contact name | Mrs Judith Edwards |
| Address |
Bristol Royal Infirmary
Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Judith.Edwards@UHBristol.nhs.uk | |
| Sponsor | University Hospitals Bristol NHS Trust (UK) |
| Address |
Research & Innovation Department
Education Centre Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Sponsor website: | http://www.uhbristol.nhs.uk/ |
| Date applied | 31/01/2013 |
| Last edited | 31/01/2013 |
| Date ISRCTN assigned | 31/01/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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