Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-01 @ 12:13 PM
Study NCT ID:
NCT05337059
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2022-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'feasibility, monocentric, prospective study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilation strategy failure', 'timeFrame': '48 hours', 'description': 'Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)'}], 'secondaryOutcomes': [{'measure': 'Short term physiologicals effects on hemodynamics', 'timeFrame': '45 minutes', 'description': 'Cardiac index assed by Echocardiography (L/min/m\\^2)'}, {'measure': 'All-cause mortality at day 28', 'timeFrame': '28 days', 'description': 'All-cause mortality'}, {'measure': 'Ventilator-free days at day 28', 'timeFrame': '28 days', 'description': 'Number of alive ventilator free days'}, {'measure': 'Short term physiologicals effects on respiratory mechanics', 'timeFrame': '45 minutes', 'description': 'recruited lung volume (mL)'}, {'measure': 'Short term physiologicals effects on gas exchange', 'timeFrame': '45 minutes', 'description': 'PaO2/FiO2 ratio (mmHg)'}, {'measure': 'Short term physiologicals effects on gas exchange', 'timeFrame': '45 minutes', 'description': 'VD/VT'}, {'measure': 'Short term physiologicals effects on gas exchange', 'timeFrame': '45 minutes', 'description': 'PaCO2 (mmHg)'}, {'measure': 'Short term physiologicals effects on respiratory mechanics', 'timeFrame': '45 minutes', 'description': 'distribution of ventilation assed by electrical impedance tomography (COV, %)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS, Human']}, 'descriptionModule': {'briefSummary': 'Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.', 'detailedDescription': 'Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 years or older\n* Moderate to severe ARDS\n* Written informed consent obtained from patient' surrogates\n\nExclusion Criteria:\n\n* Pneumothorax\n* Known pregnancy\n* Contraindication to electrical impedance tomography or esophageal pressure measurements"}, 'identificationModule': {'nctId': 'NCT05337059', 'briefTitle': 'Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..', 'orgStudyIdInfo': {'id': '2019-A03242-55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transpulmonary based ventilation strategy', 'description': 'PEEP and tidal volume will be set to target expiratory and inspiratory transpulmonary pressures of 0 and 20 cmH2O, respectively.', 'interventionNames': ['Other: PEEP and Tidal Volume Titration']}], 'interventions': [{'name': 'PEEP and Tidal Volume Titration', 'type': 'OTHER', 'description': 'PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures', 'armGroupLabels': ['Transpulmonary based ventilation strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Beloncle, MD-PhD', 'role': 'CONTACT', 'email': 'francois.beloncle@univ-angers.fr', 'phone': '+33241353815'}], 'facility': 'Chu Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Francois Beloncle, MD-PhD', 'role': 'CONTACT', 'email': 'francois.beloncle@univ-angers.fr', 'phone': '+33 2 41 35 58 65'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}