Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-13 @ 7:55 AM
Study NCT ID:
NCT05114551
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Mortality at day 7, 28 and 90', 'timeFrame': '90 days'}, {'measure': 'Length of stay in intensive care', 'timeFrame': '90 days'}, {'measure': 'Number of days without mechanical ventilation from study inclusion to day 28', 'timeFrame': '28 days'}, {'measure': 'Time frame and reasons for reintubation in case of failed extubation.', 'timeFrame': '28 days'}, {'measure': 'Use of non-invasive post-extubation ventilation', 'timeFrame': '7 days'}, {'measure': 'Use of High Flow Nasal Oxygenation post-extubation', 'timeFrame': '7 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilator Weaning', 'Predictive Value of Tests', 'Ventilator Weaning', 'Airway Extubation', 'Care Unit, Intensive', 'Critical Care', 'Area Under Curve', 'Sensitivity and Specificity', 'Logistic Models', 'Prospective Studies', 'Echocardiography, Transthoracic', 'Ultrasonography', 'Biomarkers / Blood']}, 'descriptionModule': {'briefSummary': 'Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.', 'detailedDescription': "In our intensive care units, when a patient does not have risk factors for extubation failure, SBT (Spontaneous Breathing Trial) in PSV (Pressure Support Ventilation) is usually performed first as recommended. If patient fails the first SBT in PSV or extubation, weaning is considered difficult (WIND study group AJRCCM 2017). In this case, the service protocol provides a T-piece SBT for the following SBT. In addition, this same protocol proposes to perform T-piece SBT from the first weaning event in patients with risk factors for WiPO (Weaning-induced Pulmonary Oedema), defined as obesity (BMI \\>30 kg/m2), COPD (Chronic Obstructive Pulmonary Disease) (suspected or known), or heart disease (structural \\[hypertrophic, dilated, valvular\\], functional \\[diastolic or systolic dysfunction\\], ischemic, or dysrhythmic).\n\nOur study population concerns patients for whom a T-piece trial is performed according to the service protocol.\n\nA patient is potentially includible in the study if he has been under mechanical ventilation for at least 48h and if he presents criteria of weanability with a planned T-piece SBT. As long as the inclusion and non-inclusion criteria are respected (see inclusion/non-inclusion criteria), clinical, biological and ultrasound data will be collected before and at the end of the ventilatory weaning test. If the patient fails the weaning test and/or is not extubated following the test, data from each new T-piece SBT will be collected within 7 days of inclusion.\n\nThe global management of the patient, before, during and after the inclusion of the patient in the study is the one usually practiced in our intensive care units, based on the national and international recommendations as well as the literature exposed in the protocol.\n\nDuring the patient's stay in the ICU, data from the medical record will be collected (demographic, clinical, treatment, vital status,...). A follow-up at D7, D28 and D90 will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included in this study will be all the patients hospitalized in our 2 intensive care units, under mechanical ventilation for at least 48h, meeting the criteria of weanability and for whom a T-piece SBT will be planned.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Invasive mechanical ventilation for at least 48 hours\n* Criteria for ventilatory weaning are present\n* T-piece spontaneous breathing trial planned\n* Patients with a social security program\n\nExclusion Criteria:\n\n* Patients already included in this study during the same stay in intensive care\n* Resuscitation neuromyopathy defined by an MRC (Medical Research Council) score \\< 48/60\n* Surgery planned within 72 hours\n* Prolonged ventilatory weaning (\\>7 days after the first SBT)\n* Patients with tracheostomy\n* Patients with non-reintubation decision or terminal extubation\n* Brain damaged patients\n* Patients with ECMO/ECLS\n* Tetraplegic or paraplegic patients with lesion level higher than T8\n* Nasotracheal intubated patients\n* Pregnant or breastfeeding women\n* Refusal to participate in the study (refusal by patient or family member/trusted person).\n* Patients under guardianship'}, 'identificationModule': {'nctId': 'NCT05114551', 'acronym': 'I-SWEAR', 'briefTitle': 'ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure', 'orgStudyIdInfo': {'id': 'I -Swear (RNI 2021 AUDARD)'}}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jules Audard', 'role': 'CONTACT', 'email': 'jaudard@chu-clermontferrand.fr'}], 'facility': 'CHU', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33 4 73 754963'}, {'name': 'Jules Audard', 'role': 'CONTACT', 'email': 'jaudard@chu-clermontferrand.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}