Process of weaning from mechanical ventilation Respiratory
Conditions
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 ventil
Sponsors
Guy's and St. Thomas' NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed