Condition category
Respiratory
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Beale

ORCID ID

Contact details

Adult ICU
East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 3038
Richard.Beale@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013154743

Study information

Scientific title

Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients: a randomised controlled trial

Acronym

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?

Ethics approval

St Thomas' Hospital Research Ethics Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2004

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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

Recruitment start date

01/12/2004

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Adult ICU
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)207 188 7188
crf@gstt.nhs.uk

Sponsor type

Government

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

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.