Comparison of an inhaled sedation strategy to an intravenous sedation strategy in ICU patients treated with invasive mechanical ventilation

Comparison of an inhaled sedation strategy to an intravenous sedation strategy in ICU patients treated with invasive mechanical ventilation - INASED

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004537-16-FR

Enrollment

250

Registered

2020-09-10

Start date

2020-03-26

Completion date

Unknown

Last updated

2020-09-15

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

Conditions

Prevention of delirium MedDRA version: 21.0 Level: LLT Classification code 10072852 Term: Post-injection delirium/sedation syndrome System Organ Class: 100000004852

Interventions

Trade Name: Aerrane Product Name: Isoflurane Pharmaceutical Form: Solution for infusion in administration system Trade Name: Propofol 10 mg/ml Product Name: Propofol Pharmaceutical Form: Solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patient aged 18 and over • Patient requiring mechanical ventilation for at least 24 hours • Consent obtained from the patient or a relative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient hospitalized for the following reasons for admission: - Cardiac arrest - State of refractory epilepticus - Head trauma - Stroke • Hearing, visual or aphasia disorders before inclusion • Sedation started more than 24 hours ago • Impairment of cognitive functions and / or dementia • Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT 50 mmHg • Pregnancy in progress or lactating woman • Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion • Patient under guardianship or curatorship

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre-hospital) by ISOFLURANE ™ at using an ANACONDA ™ type system, in comparison to a conventional intravenous sedation strategy.;Secondary Objective: Determine: • Morbidity and mortality • The duration of hospitalization • The number of days without mechanical ventilation • The incidence of delirium occurring after weaning from sedation • The quality of sedation • Safety in use • The dosages of pressurized amines, of vascular filling, the need to start a renal supply will be systematically collected • The incidence of states of agitation requiring the use of a complementary drug prescription • The physical restraint rate • The rate of self-extubation and ablation of catheters or probes • The rate of self-attack or hetero-aggression • Long-term cognitive consequences • Efficacy of sedation in a specific subgroup of "difficult to sedate" patients • The economic value of the isoflurane inhaled sedation strategy;Primary end point(s): Occurrence (yes / no) of a delirium in intensive care.;Timepoint(s) of evaluation of this end point: ICU exit	—

Measure

Time frame

Main Objective: Determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre-hospital) by ISOFLURANE ™ at using an ANACONDA ™ type system, in comparison to a conventional intravenous sedation strategy.;Secondary Objective: Determine: • Morbidity and mortality • The duration of hospitalization • The number of days without mechanical ventilation • The incidence of delirium occurring after weaning from sedation • The quality of sedation • Safety in use • The dosages of pressurized amines, of vascular filling, the need to start a renal supply will be systematically collected • The incidence of states of agitation requiring the use of a complementary drug prescription • The physical restraint rate • The rate of self-extubation and ablation of catheters or probes • The rate of self-attack or hetero-aggression • Long-term cognitive consequences • Efficacy of sedation in a specific subgroup of "difficult to sedate" patients • The economic value of the isoflurane inhaled sedation strategy;Primary end point(s): Occurrence (yes / no) of a delirium in intensive care.;Timepoint(s) of evaluation of this end point: ICU exit

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Secondary

Measure	Time frame
Secondary end point(s): Mortality in intensive care, mortality on D28 • Duration of hospitalization in intensive care • Number of days living without mechanical ventilation in intensive care on D28 • CAM-ICU scale (/ 8h) The quality of sedation is defined by: compliance (yes / no) with the sedation target (sedation score set as target during prescriptions) • Need for recourse to an additional drug prescription to alleviate a state of agitation (yes / no if yes neuroleptic, benzodiazepine, dexmedetomidine) • Need to use additional physical restraint to overcome a state of agitation (yes / no) • Number of accidental withdrawals by the patient of intubation tube, first vascular, nasogastric tube, urinary tube, reduced to the number of days in intensive care • Number of auto or hetero-aggressive acts reduced to the number of days in intensive care • Average hospital cost per patient • Daily and cumulative dose of sedative • The cognitive consequences will be assessed. Calculation of CDR and IQCODE scores. Evaluation within 72 hours after MMS and Trail B test extubation. Cognitive assessment (free and indexed recall, Rey figure, history recall, name and verbal fluency, TMT, SF36, PTSD Checklist, HADS, ICU memory tool) at 3 and 12 months • PRE-DELIRIC and CIWA-Ar scores (daily Clinical Institute Withdrawal Assessment Alcohol Scale, revised).;Timepoint(s) of evaluation of this end point: 28 days ou 12 months	—

Measure

Time frame

Secondary end point(s): Mortality in intensive care, mortality on D28 • Duration of hospitalization in intensive care • Number of days living without mechanical ventilation in intensive care on D28 • CAM-ICU scale (/ 8h) The quality of sedation is defined by: compliance (yes / no) with the sedation target (sedation score set as target during prescriptions) • Need for recourse to an additional drug prescription to alleviate a state of agitation (yes / no if yes neuroleptic, benzodiazepine, dexmedetomidine) • Need to use additional physical restraint to overcome a state of agitation (yes / no) • Number of accidental withdrawals by the patient of intubation tube, first vascular, nasogastric tube, urinary tube, reduced to the number of days in intensive care • Number of auto or hetero-aggressive acts reduced to the number of days in intensive care • Average hospital cost per patient • Daily and cumulative dose of sedative • The cognitive consequences will be assessed. Calculation of CDR and IQCODE scores. Evaluation within 72 hours after MMS and Trail B test extubation. Cognitive assessment (free and indexed recall, Rey figure, history recall, name and verbal fluency, TMT, SF36, PTSD Checklist, HADS, ICU memory tool) at 3 and 12 months • PRE-DELIRIC and CIWA-Ar scores (daily Clinical Institute Withdrawal Assessment Alcohol Scale, revised).;Timepoint(s) of evaluation of this end point: 28 days ou 12 months

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Countries

France

Contacts

Public ContactCecile DUCHIRON

CHRU de Brest

cecile.duchiron@chu-brest.fr+33298223187

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026