Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study
University Hospital, Brest
250 participants
Aug 6, 2020
INTERVENTIONAL
Conditions
Summary
The objective of the study is to 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 using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
Eligibility
Inclusion Criteria4
- Patient aged 18 and over
- Patient requiring mechanical ventilation for at least 24 hours
- The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.
- Consent obtained from patient or relative
Exclusion Criteria16
- Patient hospitalized for the following reasons for admission:
- Cardiac arrest
- State of refractory epilepticus
- Head trauma
- Stroke
- Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU
- 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 <30%)
- Severe acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 <100 after ventilatory optimisation))
- PaCO2 at inclusion> 50 mmHg after ventilatory optimisation
- Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion
- Patient under guardianship or curatorship
- Minor patient
- Pregnant or breastfeeding woman
- Patient not affiliated to the social security scheme
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Interventions
sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl
sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl.
Locations(12)
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NCT04341350