Mechanical Ventilation
Conditions
Keywords
critical care, sedation, Mechanically ventilated patients
Brief summary
Sedation is very important in critical care. Critically ill patients are submitted to many stressor factors that have potential to affect longterm outcomes. However, oversedation is associated with increased morbidity, including increased time of mechanical ventilation and ICU stay and longterm psychological complications. Daily interruption of sedation is associated with less time under mechanical ventilation and less posttraumatic stress disorder. Intermittent sedation, when compared with continuous sedation, is also associated with decreased time of mechanical ventilation. The aim of this study is to compare intermittent sedation with daily interruption. Our primary endpoint is free-days of mechanical ventilation in 28 days.
Detailed description
A comparison of intermittent sedation - keeping analgesia with fentanyl and midazolam or propofol as boluses if agitation (SAS 5 or more) after adequate analgesia - and daily interruption of sedation - analgesia with fentanyl and sedation wiht midazolam or propofol continuously with daily interruptions every morning until patients awake and can follow simple commands. Sedation is restarted in half previous dosage if agitation (SAS 5 or more) occur.
Interventions
PROCEDUREIntermittent sedation
Patients under intermittent sedation stay without any continuous sedation since intubation and/or admission but receive analgesics as needed and sedatives only when agitated (SAS of 5 or more).
PROCEDUREDaily interruption of sedation
Patients under daily interruption of sedation stay on continuous sedation with midazolam and fentanyl and are submitted to a daily interruption of sedation to a neurological evaluation until they reach a SAS of 4 or more, then continuous sedation is re-started in the half previous dosage.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients under mechanical ventilation with less of 24 hours and a expectative of stay intubated for more than 24 hours
Exclusion criteria
* Intubation secondary to a neurological cause * Pregnant women * Severe asthma or COPD decompensation * Palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator free-days | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Time of stay | ICU, hospitalar |
| Self-extubation | 28 days |
| Mortality | 28 days |
| Incidence of posttraumatic stress disorder | 6 months |
| Unplanned withdrawal of catheters | 28 days |
| Reintubation | 2 days after extubation |
Countries
Brazil
Outcome results
None listed