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Clinical Trials/2024-513530-37-00
2024-513530-37-00
Not yet recruiting
Phase 3

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

Centre Hospitalier Regional Et Universitaire De Brest10 sites in 1 country250 target enrollmentStarted: August 9, 2024Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
250
Locations
10
Primary Endpoint
Occurrence (yes/no) of delirium in intensive care unit
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Determine the impact on the frequency of delirium occurrence of an early inhaled sedation strategy (from induction in rapid sequence if intubated in the ICU, or from admission if intubated in the pre-hospital setting) with Isoflurane using an ANACONDA™-type system, compared with a conventional intravenous sedation strategy.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient aged 18 and over
  • •Patient requires mechanical ventilation for at least 24 hours
  • •Patient requires immediate continuous sedation for comfort, safety and to facilitate the administration of life-sustaining measures.
  • •Consent obtained from patient or relative

Exclusion Criteria

  • •Patient admitted for the following reasons : - Cardiac arrest - Refractory status epilepticus - Moderate to severe head trauma - Cerebrovascular accident
  • •Pregnant or breast-feeding women
  • •Patient not affiliated to the social security system
  • •Auditory or visual impairment, or aphasia prior to inclusion, making CAM-ICU impossible to perform
  • •Sedation for more than 24 hours
  • •Impaired cognitive function and/or dementia
  • •Contraindication to halogenated gas (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with TP<30%)
  • •Severe ARDS (Berlin criteria: PaO2/FiO2<100 after ventilatory optimization)
  • •PaCO2 at inclusion > 50 mmHg with pH<7.2 after ventilatory optimization
  • •Patient for whom a "limitation of active therapies" procedure is envisaged on inclusion

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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.

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Clinical trial project manager

Scientific

Centre Hospitalier Regional Et Universitaire De Brest

Study Sites (10)

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