Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 1:52 PM
Study NCT ID:
NCT01818895
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post traumatic Stress Disorder', 'timeFrame': "three month after patient's death", 'description': 'Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)'}], 'secondaryOutcomes': [{'measure': 'Post traumatic Stress Disorder', 'timeFrame': "12 months after patient's death", 'description': 'Post traumatic stress disorder of relatives assessed by the Impact of Event Scale -revised (IES-R)'}, {'measure': 'Anxiety and depression', 'timeFrame': "3, 6 and 12 months after patient's death", 'description': 'Anxiety and depression of the relatives, assessed by the hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Complicated grief', 'timeFrame': "6 and 12 months after patient's death", 'description': 'Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale'}, {'measure': "Relative's satisfaction", 'timeFrame': "3 months after patient's death", 'description': "Questionnaire on relative's satisfaction"}, {'measure': "Nurse's satisfaction", 'timeFrame': "within day 1 after patient's death", 'description': "Questionnaire on nurse's satisfaction"}, {'measure': "Physician's satisfaction", 'timeFrame': "within day 1 after patient's death", 'description': "Questionnaire on physician's satisfaction"}, {'measure': 'Burn out syndrome of the nurse', 'timeFrame': "within day 1 after patient's death", 'description': "Burn out syndrome of the patient's nurse as assessed by the Job Strain scale"}, {'measure': 'Burn out syndrome of the physician', 'timeFrame': "within day 1 after patient's death", 'description': "Burn out syndrome of the patient's physician as assessed by the Job Strain scale"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mechanical ventilation', 'End of life', 'Extubation', 'Terminal weaning', 'Complicated grief'], 'conditions': ['Withdrawal', 'Anxiety', 'Depression', 'Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '28936597', 'type': 'DERIVED', 'citation': 'Robert R, Le Gouge A, Kentish-Barnes N, Cottereau A, Giraudeau B, Adda M, Annane D, Audibert J, Barbier F, Bardou P, Bourcier S, Bourenne J, Boyer A, Brenas F, Das V, Desachy A, Devaquet J, Feissel M, Ganster F, Garrouste-Orgeas M, Grillet G, Guisset O, Hamidfar-Roy R, Hyacinthe AC, Jochmans S, Jourdain M, Lautrette A, Lerolle N, Lesieur O, Lion F, Mateu P, Megarbane B, Merceron S, Mercier E, Messika J, Morin-Longuet P, Philippon-Jouve B, Quenot JP, Renault A, Repesse X, Rigaud JP, Robin S, Roquilly A, Seguin A, Thevenin D, Tirot P, Vinatier I, Azoulay E, Reignier J. Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE observational study). Intensive Care Med. 2017 Dec;43(12):1793-1807. doi: 10.1007/s00134-017-4891-0. Epub 2017 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted in ICU with end of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay\n\nExclusion Criteria:\n\n* Age under 18 years\n* Non invasive mechanical ventilation\n* Brain death\n* Death before withdrawal of mechanical ventilation\n* No French-speaking relative\n* Refusal of relative to participate the study'}, 'identificationModule': {'nctId': 'NCT01818895', 'acronym': 'ARREVE', 'briefTitle': 'Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit: Impact on Relatives, Care Givers and the Dying Process - A Prospective, Multicenter, Observational Study', 'orgStudyIdInfo': {'id': 'CHD 018-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Withdrawal of mechanical ventilation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Réanimation médicale CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Angoulême', 'country': 'France', 'facility': "Réanimation, CH d'Angoulême", 'geoPoint': {'lat': 45.64997, 'lon': 0.15345}}, {'city': 'Annecy', 'country': 'France', 'facility': "Réanimation, CH d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Belfort', 'country': 'France', 'facility': 'Réanimation', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin Tripode', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Réanimation, CHU', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Boulogne', 'country': 'France', 'facility': 'CHU Ambroise Paré', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU La Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Côte de Lumière', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Charleville-Mézières', 'country': 'France', 'facility': 'Centre Hospitalier, Service de réanimation', 'geoPoint': {'lat': 49.7685, 'lon': 4.72487}}, {'city': 'Chartres', 'country': 'France', 'facility': 'CH de Chartres', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Gabriel Montpied, Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Colombes', 'country': 'France', 'facility': 'CHU Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '76202', 'city': 'Dieppe', 'country': 'France', 'facility': 'CH de Dieppe', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'CHU Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD de la Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'CH de La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'CH du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Le Puy-en-Velay', 'country': 'France', 'facility': 'CH du Puy', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'zip': '62307', 'city': 'Lens', 'country': 'France', 'facility': 'CH Docteur Schaffner', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lorient', 'country': 'France', 'facility': 'CH de Lorient', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille, Hopital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU de Marseille, Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '77000', 'city': 'Melun', 'country': 'France', 'facility': 'CH Marc Jacquet', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '82013', 'city': 'Montauban', 'country': 'France', 'facility': 'CH de Montauban', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '93105', 'city': 'Montreuil', 'country': 'France', 'facility': 'CHI André Grégoire', 'geoPoint': {'lat': 48.86415, 'lon': 2.44322}}, {'city': 'Mulhouse', 'country': 'France', 'facility': 'CH de Mulhouse', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Orléans', 'country': 'France', 'facility': 'CHU Orléans - Réanimation Médicale', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Paris Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHU Hopital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHU Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Roanne', 'country': 'France', 'facility': 'CH de Roanne', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Hôpital Delafontaine', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'CH de Saint-Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Jean Reignier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France'}, {'name': 'René Robert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Poitiers University Hospital', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Tours', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}