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 |
| Protocol serial number | N0013154743 |
| Sponsor | Guy's and St. Thomas' NHS Foundation Trust (UK) |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Adult ICU
East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 3038 |
|---|---|
| Richard.Beale@gstt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(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. |
| Key secondary outcome measure(s) |
Added as of 10/12/2007: |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
