Mechanical Ventilation Clinical Trial
— DexCapOfficial title:
Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.
NCT number | NCT04193540 |
Other study ID # | DEXCAP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2018 |
Est. completion date | August 15, 2020 |
This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 15, 2020 |
Est. primary completion date | July 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Mechanically ventilated patient (intubation or tracheotomy) - Not delirious (negative CAM ICU) - Calm and alert (RASS -1 to +1) since at least 12 hours and less than 72 hours - Receiving sedatives and/or analgesics and/or medications interfering with neurological functions - Adult patients with social security coverage Exclusion Criteria: - Brain injured patients (traumatic brain injury, ischemic or hemorrhagic stroke, sub-arachnoid hemorrhage, intra-parenchymal bleeding, hypoxic post cardiac arrest) - Known cognitive disorders (MMSE < 20) - Neurodegenerative disease - Pregnant woman - Protocol refusal by the patient or closest next-of-kin |
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decision-making capacity evaluated by Johns Hopkins ACE questionnaire | Global decision-making capacity is evaluated by Johns Hopkins ACE with a 3 groups classification (< 29 severe alteration, 29-55: moderate alteration; > 55 light alteration or normal cognitive function). | After inclusion | |
Secondary | Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient | Clinical determination of decision-making capacity of the patient blindly of Johns Hopkins ACE results | : Immediately after inclusion and prior to Johns Hopkins ACE conduct | |
Secondary | ACE sub-items | Decision-making capacity sub-items as determined by ACE (orientation, language, registration, attention and calculation, and recall) | Immediately after inclusion | |
Secondary | ICU length of stay | ICU length of stay | ICU discharge - Up to day 100 | |
Secondary | Hospital length of stay | Hospital length of stay | Hospital discharge - Up to day 200 | |
Secondary | Ventilatory free days | Ventilatory free days | Hospital discharge - Up to day 200 | |
Secondary | Sedatives used within 72 hours before decision-making capacity evaluation | Sedatives administered to the patient within 72 hours before Johns Hopkins ACE will be collected (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents) | Within 72 hours before inclusion | |
Secondary | Analgesics used within 72 hours before decision-making capacity evaluation | Analgesics administered to the patient within 72 hours before Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl) | Within 72 hours before inclusion | |
Secondary | Other molecules used within 72 hours before decision-making capacity evaluation | Other molecules administered to the patient within 72 hours before Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others) | Within 72 hours before inclusion | |
Secondary | Sedatives used during decision-making capacity evaluation | Sedatives administered to the patient during Johns Hopkins ACE will be (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents) | During inclusion | |
Secondary | Analgesics used during decision-making capacity evaluation | Analgesics administered to the patient during Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl | During inclusion | |
Secondary | Other molecules used during decision-making capacity evaluation | Other molecules administered to the patient during Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others | During inclusion |
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