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Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. However, sedation excess and ventilator support excess, both in duration and intensity, are associated with an excess morbidity. Patients usually are systematically sedated after having been intubated. Then, sedation is stopped first before ventilator support is weaning. Several studies shown that rationalized protocols of sedation and ventilation orderings had a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in surgical patients is still unknown. Moreover, no study has evaluated an optimized paired strategy of sedation-ventilation based on the priority setting of ventilation. This priority setting of ventilation should increase patient's comfort in spite of increasing sedatives and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and intensity of these treatments could improve surgical patients' outcome in ICU.
Intervention group:
Control group (standard practices):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S.O.S.-V | Other |
| |
| Standard | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy strategy | Other | Sedation & mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful intubation | Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours. | for 48 hours after intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Dose and duration of sedation | Dose and duration of sedation | Day 0 to Days 28 |
| Type and duration of mechanical ventilation | Type and duration of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald GC Chanques, MD, PhD | UH, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology & Critical Care, Estaing University Hospital | Clermont-Ferrand | 63000 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28935558 | Derived | Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, Muller L, Jung B, Belafia F, Cisse M, Delay JM, de Jong A, Lefrant JY, Futier E, Mercier G, Molinari N, Jaber S; SOS-Ventilation study investigators. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000377 | Agnosia |
| D010146 | Pain |
| D009422 | Nervous System Diseases |
| D003693 | Delirium |
| D018908 | Muscle Weakness |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D040921 | Stress Disorders, Traumatic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| Day 0 to Days 28 |
| Complications acquired in ICU | Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain | Days 28 |
| Length of stay in ICU and hospital | Length of stay in ICU and hospital | up to 6 months |
| Mortality | ICU mortality, 3 months mortality and 12 months mortality | up to 12 months |
| Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge | Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge | up to 6 months |
| Incidence and duration of organ dysfunctions | Incidence and duration of organ dysfunctions | Day 1 to Days 5 |
| Department of Anesthesiology & Critical Care, St Eloi University Hospital |
| Montpellier |
| 34000 |
| France |
| Department of Anesthesiology & Critical Care, Caremeau University Hospita | Nîmes | 30000 | France |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003221 | Confusion |
| D019965 | Neurocognitive Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068099 | Trauma and Stressor Related Disorders |