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11 February 2012
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| [ Print-friendly version ] |
| Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients |
| ISRCTN | ISRCTN82559457 |
| ClinicalTrials.gov identifier | |
| Public title | Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients |
| Scientific title | Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N0013154743 |
| Study hypothesis |
Will the use of an automated weaning system shorten the duration of mechanical ventilation, and will this be associated with reduced ventilator-associated complications e.g. pneumonia, tracheostomy?
Please note the following changes made to this ISRCTN record as of 10/12/2007: 1. The anticipated end date has been updated from 01/12/2005 to 31/12/2008 2. The target number of participants has been updated from 100 to 500 Please note the following amendments made to this ISRCTN record as of 13/02/2009: 1. Scientific title has been added. 2. The anticipated end date has been updated from 31/12/2008 to 30/06/2010 3. The sponsor has been corrected from "Fresenius Kabi Deutschland GmbH (Germany)" to "Guy's and St. Thomas' NHS Foundation Trust (UK)". This is due to an error in initial information provided for this ISRCTN record. |
| Lay summary | |
| Ethics approval | St Thomas' Hospital Research Ethics Committee |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Process of weaning from mechanical ventilation |
| Participants - inclusion criteria |
Added as of 10/12/2007:
Major entry criteria (suspected or proven infection, presence of a systemic response to the infection within the 48-hour period immediately preceding enrolment into the study, have or have had one or more sepsis-induced organ failures within the 48-hour period immediately preceding enrolment into the study). 1. Age >=18 years 2. Acute Physiology and Chronic Health Evaluation II (APACHE II) score =10 3. Precipitating injury (surgery, trauma, hypovolemia, episode of infection or sepsis) occurred within the last 48 hours before Intensive Care Unit (ICU) entry 4. Expected Length Of Stay (LOS) in the ICU >3 days 5. Indication for enteral nutrition for 5-10 days 6. Start of nutritional therapy with Intestamin or control supplement within 24 hours after inclusion criteria are fulfilled |
| Participants - exclusion criteria |
1. Under 18 years of age
2. Requirement for high doses of vasopressor 3. Body temperature greater than 39ºC or less than 36ºC 4. GCS = 12 without or with minimal sedation 5. 'Do Not Resuscitate' order or expected short term prognosis 6. Patients chronically ventilated at home with tracheostomy 7. Patients with primary neurological cause of ventilator dependence 8. Pregnancy 9. Prolonged cardiac arrest with poor neurological prognoses 10. Inability to obtain consent from patient or legal representative |
| Anticipated start date | 01/12/2004 |
| Anticipated end date | 30/06/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 500 |
| Interventions | This is a randomised controlled trial comparing the ICU's standard ventilator weaning protocol and the SmartCare automated weaning system. Patients who are assessed as likely to need mechanical ventilation for a period of 48 hours or more will be randomised to be weaned from mechanical ventilation using either the standard protocol or the automated weaning system. Weaning will be initiated when, in the opinion of the clinical team, the patient is sufficiently improved as to be able to tolerate a spontaneous mode of ventilation and has met defined gas exchange and ventilatory support criteria. Once in the weaning phase, weaning will proceed according to the manual or SmartCare algorithms but will be suspended if the patient's clinical condition deteriorates, and re-instituted once the patient has improved sufficiently for weaning to recommence. |
| Primary outcome measure(s) | Time from the initiation of weaning to successful separation of the patient from the ventilator, defined as no longer needing mechanical ventilation for a minimum period of 48 hours. |
| Secondary outcome measure(s) |
Added as of 10/12/2007:
1. Mortality (28-day, ICU and hospital, six-months) 2. Infectious complications (e.g. pneumonia, wound infection, abscesses) 3. APACHE II 4. Organ failure-free days 5. LOS in ICU 6. LOS in hospital (intervention until discharge) 7. Duration of antibiotic treatment (antibiotics days) 8. Duration of ventilation (ventilator days) 9. Duration of renal support |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Richard Beale |
| Address |
Adult ICU
East Wing St Thomas' Hospital Lambeth Palace Road |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| Tel | +44 (0)20 7188 3038 |
| Fax | +44 (0)20 7960 5842 |
| Richard.Beale@gstt.nhs.uk | |
| Sponsor | Guy's and St. Thomas' NHS Foundation Trust (UK) |
| Address |
St Thomas' Hospital
Westminster Bridge Road |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| Tel | +44 (0)207 188 7188 |
| Sponsor website: | http://www.guysandstthomas.nhs.uk/ |
| Date applied | 30/09/2005 |
| Last edited | 13/02/2009 |
| Date ISRCTN assigned | 30/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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