Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Procedure: Intermittent sedation
* Procedure: Daily interruption of sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Intermittent sedation<br> | Procedure: Intermittent sedation<br>* 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).<br>* Other names: Fentanyl, midazolam, propofol;|
| Active Comparator: 2. Daily interruption of sedation<br> | Procedure: Daily interruption of sedation<br>* 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.<br>* Other names: Fentanyl, midazolam, propofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free-days |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28 days | 
| Time of stay |  | ICU, hospitalar | 
| Self-extubation |  | 28 days | 
| Reintubation |  | 2 days after extubation | 
| Incidence of posttraumatic stress disorder |  | 6 months | 
| Unplanned withdrawal of catheters |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical care, sedation, Mechanically ventilated patients