Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
Study NCT ID:
NCT04341350
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2020-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007530', 'term': 'Isoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a delirium in intensive care', 'timeFrame': '28 days', 'description': 'Occurrence of delirium in intensive care will be observed (yes / no)'}], 'secondaryOutcomes': [{'measure': 'Mortality in intensive care', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Mortality in intensive care will be observed'}, {'measure': 'Mortality at day 28', 'timeFrame': '28 days', 'description': 'Mortality at day 28 will be observed'}, {'measure': 'Hospital cost per patient', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'The average cost of hospitalization for each patient will be calculated taking into account their length of hospital stay, examinations carried out and medical treatment taken.'}, {'measure': 'Number of days with vasopressors or inotropic agents', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Number of days with vasopressors or inotropic agents will be observed'}, {'measure': 'Number of days with sedation', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Number of days with sedation will be observed'}, {'measure': 'Cumulative dose anesthetics drugs', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Cumulative dose anesthetics drugs will be observed'}, {'measure': 'Duration of anesthetics drugs', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Duration of anesthetics drugs will be observed'}, {'measure': 'Maximum dose of vasopressors or inotropic agents', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Maximum dose of vasopressors or inotropic agents will be observed'}, {'measure': 'Ventilation free days at 28 days following randomisation', 'timeFrame': '28 days', 'description': 'Ventilation free days at 28 days following randomisation will be observed'}, {'measure': 'Incidence of delirium', 'timeFrame': '28 days', 'description': 'Incidence of delirium will be observed'}, {'measure': 'Duration of delirium', 'timeFrame': '28 days', 'description': 'Duration of delirium will be observed'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Length of ICU stay will be calculated'}, {'measure': 'Requirement of patients physical restraints', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Requirement of physical restraints, of patients with unplanned extubation, unplanned catheter, urinary probe or gastric probe removal will be observed'}, {'measure': 'Self aggressive act', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Self aggressive act will be observed'}, {'measure': 'Hetero-aggressive act', 'timeFrame': 'Throuh exit from the intensive care unit, an average of 28 days', 'description': 'Hetero-aggressive act will be observed'}, {'measure': 'Evaluation of cognitive functions', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Cognitive function will be evaluated at discharge, 3- and 12 months using two kinds of score :\n\n* Cantab test, combining 6 cognitive evaluations with an iPad during a 45-60 minutes medical consultation\n* PCLS (Posttraumatic stress disorder Checklist Scale), HADS (Hospital Anxiety and Depression scale), SF36 (medical outcome study short form 36), IADL (instrumental activities of daily living) practised by a clinical research associate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Delirium']}, 'referencesModule': {'references': [{'pmid': '33608400', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Sedation-analgesia is used in most patients treated with mechanical ventilation (MV). The usual benzodiazepine and morphine sedation reduces pain and anxiety and allows tolerance of invasive procedures in intensive care. These molecules, used as part of the sedation titration protocol or the daily sedation stop protocol, have improved patient outcomes.\n\nAlthough 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).\n\nThis 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.\n\nHalogenated 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 and over\n* Patient requiring mechanical ventilation for at least 24 hours\n* The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.\n* Consent obtained from patient or relative\n\nExclusion Criteria:\n\nPatient hospitalized for the following reasons for admission:\n\n* Cardiac arrest\n* State of refractory epilepticus\n* Head trauma\n* Stroke\n\n * Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU\n * Sedation started more than 24 hours ago\n * Impairment of cognitive functions and / or dementia\n * Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT \\<30%)\n * Severe acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 \\<100 after ventilatory optimisation))\n * PaCO2 at inclusion\\> 50 mmHg after ventilatory optimisation\n * Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion\n * Patient under guardianship or curatorship\n * Minor patient\n * Pregnant or breastfeeding woman\n * Patient not affiliated to the social security scheme'}, 'identificationModule': {'nctId': 'NCT04341350', 'acronym': 'INASED', 'briefTitle': 'Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study', 'orgStudyIdInfo': {'id': 'INASED (29BRC19.0280)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual sedation', 'description': 'Sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug.', 'interventionNames': ['Drug: Propofol + analgesic drug']}, {'type': 'EXPERIMENTAL', 'label': 'Inhaled sedation', 'description': 'Sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of an analgesic drug.', 'interventionNames': ['Drug: Isoflurane + analgesic drug']}], 'interventions': [{'name': 'Propofol + analgesic drug', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Usual sedation']}, {'name': 'Isoflurane + analgesic drug', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Inhaled sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18000', 'city': 'Bourges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anna BOURREAU, Dr', 'role': 'CONTACT', 'email': 'anna.bourreau@ch-bourges.fr', 'phone': '02 48 48 48 48', 'phoneExt': '+33'}], 'facility': 'CH Bourges', 'geoPoint': {'lat': 47.08333, 'lon': 2.4}}, {'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Bailly, MD', 'role': 'CONTACT', 'email': 'pierre.bailly@chu-brest.fr', 'phone': '02 98 34 71 81', 'phoneExt': '+33'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '91106', 'city': 'Corbeil-Essonnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Billiou Cecilia, MD', 'role': 'CONTACT', 'email': 'cecilia.billiou@chsf.fr', 'phone': '0161693519'}], 'facility': 'CH Corbeil Essonnes', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '72039', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe GUITTON, Dr', 'role': 'CONTACT', 'email': 'cguitton@ch-lemans.fr', 'phone': '02 53 04 04 42', 'phoneExt': '+33'}], 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '56322', 'city': 'Lorient', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume GRILLET, Dr', 'role': 'CONTACT', 'email': 'g.grillet@ghbs.bzh'}], 'facility': 'GHBS Lorient', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '77000', 'city': 'Melun', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandie MAZERAND, MD', 'role': 'CONTACT', 'email': 'sandie.mazerand@ghsif.fr', 'phone': '0181742641', 'phoneExt': '+33'}], 'facility': 'CH Melun', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'SUSPENDED', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '29672', 'city': 'Morlaix', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre-Yves EGRETEAU, Dr', 'role': 'CONTACT', 'email': 'pyegreteau@ch-morlaix.fr', 'phone': '02 98 62 60 95', 'phoneExt': '+33'}], 'facility': 'CH Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '86021', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud THILLE, Pr', 'role': 'CONTACT', 'email': 'arnaud.thille@chu-poitiers.fr', 'phone': '05 49 44 43 67', 'phoneExt': '+33'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florian REIZINE, Dr', 'role': 'CONTACT', 'email': 'florian.reizine@chu-rennes.fr'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37044', 'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde BARBAZ', 'role': 'CONTACT', 'phone': '07.62.12.70.34'}, {'role': 'CONTACT', 'email': 'mathildebarbaz@gmail.com'}], 'facility': 'CHU Tours - Réanimation Chirurgicale', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephan EHRMANN, Pr', 'role': 'CONTACT', 'email': 'stephan.ehrmann@univ-tours.fr', 'phone': '06 71 10 33 02', 'phoneExt': '+33'}], 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Pierre Bailly, MD', 'role': 'CONTACT', 'email': 'pierre.bailly@chu-brest.fr', 'phone': '02 98 34 71 81', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Pierre Bailly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Brest'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}