Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
NCT ID: NCT04341350
Last Updated: 2025-04-04
Study Results
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Basic Information
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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2020-08-06
2026-08-31
Brief Summary
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Detailed Description
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Although necessary, these drugs, by mechanisms still uncertain, would promote the occurrence of resuscitation delirium. Delirium itself responsible for worsening morbidity and mortality (increase in the duration of MV, increase in the length of hospital stay, discussed increase in mortality, long-term cognitive sequelae).
This finding favored the use of new drugs in the sedation strategies of patients on MV. Dexmedetomidine has for example reduced the number of days of delirium, the number of days of coma and even mortality in septic patients. Its large-scale use has however been questioned by a recent study.
Halogenated gases have been used for a long time in anesthesia. Their pharmacodynamics, their positive and adverse effects, their therapeutic margins are well known. Thanks to technical innovations they can be used on resuscitation respirators. Several studies on targeted populations have shown the feasibility and the benefits of this use, in particular, the absence of accumulation, the absence of tachyphylaxis, the broad therapeutic range, the small interindividual variation, the rapidity of efficacy and the speed of awakening. Safety in use for the staff in charge of the patient is established. In addition, their potential neuroprotective effect would make it an anesthetic of choice in the prevention of resuscitation delirium.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Usual sedation
Sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug.
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
Inhaled sedation
Sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of an analgesic drug.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Pierre Bailly, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU Brest
Locations
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CH Bourges
Bourges, , France
CHU de Brest
Brest, , France
CH Corbeil Essonnes
Corbeil-Essonnes, , France
CH Le Mans
Le Mans, , France
GHBS Lorient
Lorient, , France
CH Melun
Melun, , France
CHU Montpellier
Montpellier, , France
CH Morlaix
Morlaix, , France
CHU Poitiers
Poitiers, , France
CHU Rennes
Rennes, , France
CHU Tours - Réanimation Chirurgicale
Tours, , France
CHU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Mathilde BARBAZ
Role: primary
Role: backup
References
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Bailly P, Egreteau PY, Ehrmann S, Thille AW, Guitton C, Grillet G, Reizine F, Huet O, Jaber S, Nowak E, L'her E. Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial. BMJ Open. 2021 Feb 19;11(2):e042284. doi: 10.1136/bmjopen-2020-042284.
Other Identifiers
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INASED (29BRC19.0280)
Identifier Type: -
Identifier Source: org_study_id
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