Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients

ISRCTN	ISRCTN82559457
DOI	https://doi.org/10.1186/ISRCTN82559457
Secondary identifying numbers	N0013154743

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 14/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Beale
Scientific

Adult ICU
East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 3038
Email	Richard.Beale@gstt.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients: a randomised controlled trial
Study objectives	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?
Ethics approval(s)	St Thomas' Hospital Research Ethics Committee
Health condition(s) or problem(s) studied	Process of weaning from mechanical ventilation
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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
Overall study start date	01/12/2004
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	500
Key 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
Key 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
Date of first enrolment	01/12/2004
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Adult ICU

London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St. Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
England
United Kingdom

Phone	+44 (0)207 188 7188
Email	crf@gstt.nhs.uk
Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

14/06/2016: No publications found, verifying study status with principal investigator.
13/02/2009:
1. The 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.
10/12/2007:The anticipated end date has been updated from 01/12/2005 to 31/12/2008 and the target number of participants has been updated from 100 to 500.