A Phase 3 interventional study of Therapy strategy in Surgery, Critical Illness and Mechanical Ventilation Complication, sponsored by University Hospital, Montpellier. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University Hospital, Montpellier · Phase 3, Interventional, and Treatment
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):
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 140 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 224 are open to participants now.
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Exclusion Criteria:
Other: Therapy strategy
Sedation \& mechanical ventilation
Time to successful intubation
Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours.
Time frame: for 48 hours after intubation
Dose and duration of sedation
Dose and duration of sedation
Time frame: Day 0 to Days 28
Type and duration of mechanical ventilation
Type and duration of mechanical ventilation
Time frame: Day 0 to Days 28
Complications acquired in ICU
Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain
Time frame: Days 28
Length of stay in ICU and hospital
Length of stay in ICU and hospital
Time frame: up to 6 months
Mortality
ICU mortality, 3 months mortality and 12 months mortality
Time frame: 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
Time frame: up to 6 months
Incidence and duration of organ dysfunctions
Incidence and duration of organ dysfunctions
Time frame: Day 1 to Days 5
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier