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Comparison of an inhaled sedation strategy with an intravenous sedation strategy in intensive care patients treated with invasive mechanical ventilation: INASED study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513530-37-00
Acronym
29BRC19.0280
Enrollment
250
Registered
2024-08-09
Start date
2024-08-09
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Brief summary

Occurrence (yes/no) of delirium in intensive care unit

Detailed description

ICU mortality, D28 mortality, - Length of stay in intensive care, - Number of days living without mechanical ventilation in intensive care at D28, - CAM-ICU scale (2 times/day), - The quality of sedation is defined by: compliance (yes/no) with the sedation target (sedation score set as the target when prescribing), - Need for additional medication to alleviate agitation (yes/no, and if yes neuroleptic, benzodiazepine, dexmedetomidine), - Need for additional physical restraint to alleviate a state of agitation (yes/no), - Number of accidental removals by the patient of intubation tubes, vascular access tubes, nasogastric tubes and urinary catheters, based on the number of days in intensive care., - Number of self- or hetero-aggressive acts per number of days in intensive care, - Average hospital costs per patient, - Daily and cumulative dose of sedative, - Cognitive consequences will be assessed. Calculation of CDR and IQCODE scores. Cognitive, psychological and quality of life assessment at 3 and 12 months.

Interventions

DRUGISOFLURANE BELAMONT
DRUGPropofol Baxter 10 mg/mL Emulsion zur Injektion/Infusion
DRUGSUFENTANIL

Sponsors

Centre Hospitalier Regional Et Universitaire De Brest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence (yes/no) of delirium in intensive care unit

Secondary

MeasureTime frame
ICU mortality, D28 mortality, - Length of stay in intensive care, - Number of days living without mechanical ventilation in intensive care at D28, - CAM-ICU scale (2 times/day), - The quality of sedation is defined by: compliance (yes/no) with the sedation target (sedation score set as the target when prescribing), - Need for additional medication to alleviate agitation (yes/no, and if yes neuroleptic, benzodiazepine, dexmedetomidine), - Need for additional physical restraint to alleviate a state of agitation (yes/no), - Number of accidental removals by the patient of intubation tubes, vascular access tubes, nasogastric tubes and urinary catheters, based on the number of days in intensive care., - Number of self- or hetero-aggressive acts per number of days in intensive care, - Average hospital costs per patient, - Daily and cumulative dose of sedative, - Cognitive consequences will be assessed. Calculation of CDR and IQCODE scores. Cognitive, psychological and quality of life assessme

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026