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Clinical trial

Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study

ID
Name
INASED (29BRC19.0280)
Description
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.
Trial arms
Trial start
2020-08-06
Estimated PCD
2024-09-01
Trial end
2025-08-01
Status
Recruiting
Treatment
Propofol + analgesic drug
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
Arms:
Usual sedation
Isoflurane + analgesic drug
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.
Arms:
Inhaled sedation
Size
250
Primary endpoint
Occurrence of a delirium in intensive care
28 days
Eligibility criteria
Inclusion Criteria: * 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 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 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}
Updated at
2024-01-12

1 organization

2 products

1 indication

Organization
University Hospital Brest
Product
Propofol
Indication
Delirium
Product
Isoflurane