Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-09 @ 1:58 AM
Study NCT ID:
NCT02911506
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2016-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of sleep quality by polysomnography recording on the extubation day.', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'conditions': ['Sleep Quality', 'Extubation Failure']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care unit patients, intubated at least 24 hours, at risk of extubation failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intensive care units patients intubated for at least 24 hours with at least on of the four following risk factor : aged of 65 years or more, any underlying chronic cardiac or lung disease, mechanical ventilation for more than 7 days.\n* aged of 18 years or more\n\nExclusion Criteria:\n\n* peripheral or central nervous system pathology\n* known psychiatric pathology or agitation\n* patient with decision of no reintubation\n* patient refusal\n* clinical worsening before polysomnography ( shock with vasopressors drugs, coma, PaO2/FiO2 ratio \\< 150 with respiratory distress signs, coma with Glasgow scale \\<8)\n* pregnant or breastfeeding women\n* patient under legal guardianship or protection\n* patient with no health insurance coverage\n* aged \\< 18 years'}, 'identificationModule': {'nctId': 'NCT02911506', 'acronym': 'WEAN SLEEP 2', 'briefTitle': 'Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'WEAN SLEEP 2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Polysomnography', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}