Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT05719194
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Personalized Weaning Strategy on Weaning Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015610', 'term': 'Serum Bactericidal Test'}], 'ancestors': [{'id': 'D008826', 'term': 'Microbial Sensitivity Tests'}, {'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004353', 'term': 'Drug Evaluation, Preclinical'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind is not possible as this study evaluate a care strategy. However, in order to limit evaluation bias, the methodologist will be blinded to the group.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Pragmatic, controlled, multicenter, stepped wedge cluster randomized trial, considering centers as clusters.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of tracheostomy during the ICU stay.', 'timeFrame': '28 days'}, {'measure': 'Incidence of non-invasive ventilation or high-flow nasal oxygenation post-extubation, both prophylactic and curative.', 'timeFrame': '72 hours after extubation.'}, {'measure': 'Incidence of use for diuretics or beta-blockers for failed weaning trials or WIPO.', 'timeFrame': '28 days'}, {'measure': 'Incidence of the absence of extubation despite a successful SBT.', 'timeFrame': '28 days'}, {'measure': 'Time and reason for reintubation in case of failed extubation.', 'timeFrame': '28 days'}], 'primaryOutcomes': [{'measure': 'Mortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28.', 'timeFrame': '28 days', 'description': 'Composite score including those three criteria such that mortality is a more severe outcome than reintubation and the number of VFDs, and reintubation is a more severe outcome than the number of VFDs'}], 'secondaryOutcomes': [{'measure': 'Rate of extubation success after the first SBT.', 'timeFrame': '72 hours from first SBT'}, {'measure': 'Rate of reintubation', 'timeFrame': '72 hours from first SBT'}, {'measure': 'Rate of reintubation', 'timeFrame': '72 hours from extubation'}, {'measure': 'Reintubation rate within 7 days of extubation.', 'timeFrame': '7 days after extubation'}, {'measure': 'Time from first SBT to extubation.', 'timeFrame': '28 days'}, {'measure': 'SBT failure rate', 'timeFrame': '28 days', 'description': 'Defined by respiratory rate increase of 50% or \\> 35/min, dyspnea, SpO2 \\< 88% or decrease of 5%, heart rate increase \\> 20%, systolic blood pressure increase \\> 20%, agitation, sweating.'}, {'measure': 'Number of days without mechanical ventilation', 'timeFrame': 'From day one of first SBT to day 28'}, {'measure': 'Length of stay in the ICU and in the hospital.', 'timeFrame': '90 days'}, {'measure': 'Mortality of ICU stay/hospital stay.', 'timeFrame': '90 days'}, {'measure': 'Mortality at day 28.', 'timeFrame': '28 days'}, {'measure': 'Mortality at day 90.', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WIPO', 'Extubation', 'Spontaneous Breathing Trial', 'T-piece', 'Pressure Support Ventilation', 'Weaning strategy', 'Personalization'], 'conditions': ['Weaning', 'Mechanical Ventilation', 'Intubation']}, 'descriptionModule': {'briefSummary': 'Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.\n\nEven when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.\n\nThere is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.\n\nStudies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).\n\nThe purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, heart disease) improves weaning success compared with usual practice.', 'detailedDescription': 'Before the study begin, all participating centers will be randomized to determine the time between the control and the interventional period. Patients included in the study will not be randomized individually but will be managed either according to the standard of care of the service or according to the personalized strategy (according to the stepped wedge group of the center).\n\n* Control period: Patients will be subjected to a weaning strategy in accordance with the usual care practices of the service (evaluation of the criteria of weanability, the modalities of the spontaneous breathing trial and extubation)\n* Interventional period: Patients will undergo a protocolized and standardized weaning strategy, including a daily assessment of weaning criteria, and a weaning trial (PSV or T-piece) whose modalities will be defined by the presence or the absence of weaning induced pulmonary oedema risk factors. These are :\n* Obesity defined as BMI greater than 30 kg/m²\n* Suspected or known COPD\n* Heart disease whether it is structural (hypertrophic, dilated, valvular), functional (diastolic or systolic dysfunction), ischemic, or dysrhythmic.\n\nStep 1 :\n\nDaily assessment of weaning criteria in accordance with the study protocol\n\nStep 2 :\n\n* No risk factors : spontaneous breathing trial for 1 hour with pressure support ventilation (setting a pressure support level of 5 to 8 cm of water with no PEEP)\n* Risk factors : spontaneous breathing trial with a T-piece for 1 hour, measuring protein and hemoglobin by blood sample before and after the trial.\n\nStep 3 : Reconnecting the patient for at least 30 minutes and extubation if the SBT is successful. If not, the optimization of cardiac function or fluid overload will be the responsibility of the clinician.\n\nDecisions regarding the use of non-invasive ventilation (NIV) or high-flow nasal oxygenation, will be made based on each centre\\'s expertise and current clinical practice to minimize interference with the study procedure. However, knowing the recent data and the possible superiority of NIV in preventing post-extubation respiratory failure for high risk patients, investigators will be strongly encouraged to prioritize the prophylactic use of NIV (over high-flow nasal oxygenation) after tracheal extubation.\n\nPatients will be assessed by members of the investigating center\\&amp;#39;s research team (under the supervision of the centre\\'s investigators) at least daily during hospitalization in the ICU and until day 28 post-randomization, as well as at discharge and at 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria : all patients ≥ 18 y.o admitted to the ICU, under invasive mechanical ventilation for more then 24 hours and fullfilling the following weaning criteria :\n\n* Resolution or improvement of the condition that led to intubation, as judged by the clinician in charge of the patient.\n* Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mmHg, heart rate less than 140 beats/min, without or with low doses of vasopressors.\n* Glasgow score of 13 or greater and Richmond Agitation-Sedation Scale (RASS) score between -1 and +1.\n* Respiratory stability defined as: oxygen saturation \\> 90% with inspired oxygen fraction ≤ 0.5 and PEEP ≤ 8 cmH2O, respiratory rate \\< 35/min, spontaneous tidal volume \\> 5 mL/kg, and peak inspiratory pressure ≤ 15 cmH2O.\n* Few secretions (\\< 3 aspirations in the past 8 hours).\n* Effective cough.\n* Negative leak test (\\>100 mL or \\>10%).\n* No surgery planned within 72 hours.\n* Patients with a social security plan.\n\nExclusion Criteria:\n\n* Acute cerebral pathology requiring admission to intensive care and/or mechanical ventilation with tracheal intubation for neurological reasons (Glasgow score \\<13 at the time of intubation or CT scan abnormality): hemorrhagic stroke without or with vascular malformation (aneurysm, arterio-venous malformation...), ischemic stroke, head trauma, cerebral anoxo-ischemia after cardiac arrest.\n* Tetraplegic or paraplegic patients with lesion level higher than D8.\n* Peripheral neuromuscular pathology (underlying myopathy or myasthenia).\n* ICU's Neuromyopathy.\n* Tracheostomy.\n* Patients with a decision of non-reintubation or terminal intubation.\n* Pregnant or lactating women.\n* Patients already included in this study.\n* Patients under guardianship, curatorship or safeguard of justice."}, 'identificationModule': {'nctId': 'NCT05719194', 'acronym': 'P-Wean', 'briefTitle': 'Effect of a Personalized Weaning Strategy on Weaning Success', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Effect of a Personalized Weaning Strategy on Weaning Success', 'orgStudyIdInfo': {'id': 'P-Wean PHRC IR 2020 AUDARD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard intervention', 'interventionNames': ['Other: Standard SBT']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized intervention - WIPO risk factors vs no risk factors', 'interventionNames': ['Other: SBT with T-piece or PSV']}], 'interventions': [{'name': 'Standard SBT', 'type': 'OTHER', 'description': 'Weaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities.', 'armGroupLabels': ['Standard intervention']}, {'name': 'SBT with T-piece or PSV', 'type': 'OTHER', 'description': '\\- Risk factors of WIPO\n\nStep 1 : Daily assessment of weaning criteria in accordance with the study protocol.\n\nStep 2 : Spontaneous breathing trial with T-piece for an hour. Measure of protein and haemoglobin by blood sample before and after the trial.\n\nStep 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful.\n\nIf SBT failed : no extubation and new SBT the next day. Optimization of cardiac function or fluid overload will be in charge of the investigator.\n\n\\- No risk factors of WIPO\n\nStep 1 : Daily assessment of weaning criteria in accordance with the study protocol.\n\nStep 2 : Spontaneous breathing trial with pressure support ventilation (pressure support from 5 to 8 cmH20 - PEEP at 0 cmH20) for an hour.\n\nStep 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful.', 'armGroupLabels': ['Personalized intervention - WIPO risk factors vs no risk factors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu BIAIS', 'role': 'CONTACT', 'email': 'matthieu.biais@chu-bordeaux.fr'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jules AUDARD', 'role': 'CONTACT', 'email': 'jaudard@chu-clermontferrand.fr'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaud CRESPY', 'role': 'CONTACT', 'email': 'TCrespy@chu-grenoble.fr'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric KIPNIS', 'role': 'CONTACT', 'email': 'ekipnis@gmail.com'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice THIOLLIERE', 'role': 'CONTACT', 'email': 'fabrice.thiolliere01@chu-lyon.fr'}], 'facility': 'CHU de Lyon - Hôpital Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Samir JABER', 'role': 'CONTACT', 'email': 's-jaber@chu-montpellier.fr'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre BOURDIOL', 'role': 'CONTACT', 'email': 'alexandre.bourdiol@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme MOREL', 'role': 'CONTACT', 'email': 'jerome.morel@chu-st-etienne.fr'}], 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure CROGNIER', 'role': 'CONTACT', 'email': 'crognier.l@chu-toulouse.fr'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'llaclautre_perrier@chu-clermontferrand.fr', 'phone': '+33473754963'}], 'overallOfficials': [{'name': 'Jules Audard', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}