Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02520193
Status:
UNKNOWN
Last Update Posted:
2017-05-05
First Post:
2015-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007362', 'term': 'Intensive Care Units'}], 'ancestors': [{'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 772}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation', 'timeFrame': '28 days after intubation'}], 'secondaryOutcomes': [{'measure': 'The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale', 'timeFrame': 'end of Intensive Care Unit stay, an expected average of 10 days'}, {'measure': 'The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale', 'timeFrame': 'end of Intensive Care Unit stay, an expected average of 10 days'}, {'measure': 'The incidence of delirium with CAM-ICU scale', 'timeFrame': 'end of Intensive Care Unit stay, an expected average of 10 days'}, {'measure': 'Hospital stay duration', 'timeFrame': 'End of hospital stay, an expected average of 20 days'}, {'measure': 'Place where the patient is transferred at the end of the hospital stay', 'timeFrame': 'End of hospital stay, an expected average of 20 days'}, {'measure': 'The delay, in number of days between intubation and the first successful spontaneous breathing trial', 'timeFrame': 'End of Intensive Care Unit stay, an expected average of 10 days'}, {'measure': 'The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation', 'timeFrame': 'end of Intensive Care Unit stay, an expected average of 10 days'}, {'measure': 'Time between intubation and the first stand-up position in days', 'timeFrame': 'end of Intensive Care Unit stay, an expected average of 10 days'}, {'measure': 'ICU stay duration', 'timeFrame': 'end of Intensive Care Unit stay, an expected average of 10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early mobilisation', 'Invasive ventilation', 'Ventilator free days', 'Intensive Care Unit'], 'conditions': ['ICU Acquired Weakness']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.\n\nThis study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.\n\nAt the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.\n\nThe study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission in intensive care unit\n* Invasive ventilation for more than 24 hours\n* Invasive ventilation for less than 48 hours\n* Expected duration of invasive ventilation of more than 24 hours at the time of inclusion.\n\nExclusion Criteria:\n\n* Pregnancy\n* Failure to obtain a consent from someone authorized\n* Patient under law protection.\n* Patient non-affiliated to a health care system.\n* Active therapeutic limitation\n* Hospitalisation for more than 7 days before intubation\n* Admission in intensive care unit after a surgical procedure, burn or trauma\n* Admission in intensive care unit because of neurological disease\n* Previously known neuromuscular disease\n* Bilateral lower limbs amputation\n* BMI above 40 kg/m²\n* Limitation in daily activities before ICU admission\n* Chronic ventilation (more than 12h /24 hours) on tracheotomy before ICU admission\n* Participation in another interventional clinical study related to mobilization or in an interventional clinical study which has mechanical ventilation duration as primary outcome\n* Previous enrolment in the same phase of the EarlyMob study'}, 'identificationModule': {'nctId': 'NCT02520193', 'acronym': 'EarlyMob', 'briefTitle': 'Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients', 'orgStudyIdInfo': {'id': 'PHRIP 2014-01'}, 'secondaryIdInfos': [{'id': '2015-A00741-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard mobilization strategy'}, {'type': 'EXPERIMENTAL', 'label': 'protocolized early mobilization strategy', 'interventionNames': ['Procedure: Protocolized early mobilization in ICU']}], 'interventions': [{'name': 'Protocolized early mobilization in ICU', 'type': 'PROCEDURE', 'armGroupLabels': ['protocolized early mobilization strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jean-Charles PREISER', 'role': 'CONTACT'}], 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Xavier WITTEBOLE', 'role': 'CONTACT'}], 'facility': 'Cliniques Universitaires Saint-Luc - Service des soins intensifs', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Vincent FRAIPONT', 'role': 'CONTACT'}], 'facility': 'CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pierre DAMAS', 'role': 'CONTACT'}], 'facility': 'CHU de Liege - Service de soins intensifs généraux', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Yvoir', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Geoffrey HORLAIT', 'role': 'CONTACT'}], 'facility': 'Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain MERCAT', 'role': 'CONTACT'}], 'facility': 'CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenael PRAT', 'role': 'CONTACT'}], 'facility': 'CHU de Brest - Service de réanimation médicale', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '95303', 'city': 'Cergy-Pontoise', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cédric CLEOPHAX', 'role': 'CONTACT'}], 'facility': 'CH de Pontoise - Serive de réanimation médicale - CH René Dubos', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Keyvan RAZAZI', 'role': 'CONTACT'}], 'facility': 'AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle VINATIER', 'role': 'CONTACT'}], 'facility': 'CHD Vendée - Service de Réanimation Polyvalente', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '17000', 'city': 'La Rochelle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime LELOUP', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas TERZI', 'role': 'CONTACT'}], 'facility': 'CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas CHUDEAU', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Saad NSEIR', 'role': 'CONTACT'}], 'facility': 'CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69007', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gael BOURDIN', 'role': 'CONTACT'}], 'facility': 'CH St Joseph St Luc - Service de Réanimation Polyvalente', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '76290', 'city': 'Montivilliers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mehdi BOUSTA', 'role': 'CONTACT'}], 'facility': 'Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe GUITTON', 'role': 'CONTACT'}], 'facility': 'CHU de Nantes - Service de Réanimation Médicale Polyvalente', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean DELLAMONICA', 'role': 'CONTACT'}], 'facility': "CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Muriel FARTOUKH', 'role': 'CONTACT'}, {'name': 'Tai PHAM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'AP-HP Hôpital Tenon - Service de Réanimation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Luc DIEHL', 'role': 'CONTACT'}], 'facility': 'AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier COINTAULT', 'role': 'CONTACT'}], 'facility': "CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie RUIZ', 'role': 'CONTACT'}], 'facility': 'Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Lise Piquilloud Imboden', 'role': 'CONTACT', 'email': 'lise.piquilloud@chuv.ch'}], 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Laurent POIROUX', 'role': 'CONTACT', 'email': 'LaPoiroux@chu-angers.fr', 'phone': '++33 2 41 35 64 40'}, {'name': 'Lise PIQUILLOUD, MD', 'role': 'CONTACT', 'email': 'lise.piquilloud@chuv.ch', 'phone': '++41 79 556 68 27'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}