Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-28 @ 6:12 PM
Study NCT ID:
NCT06051292
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2023-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal catheter filling volume', 'timeFrame': 'up 1 hour after catheter placement', 'description': 'The clinician will determine the optimal filling volume of the catheter using two distinct methods'}], 'secondaryOutcomes': [{'measure': 'Transpulmonary driving pressure', 'timeFrame': 'up 1 hour after catheter placement', 'description': 'The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter'}, {'measure': 'Time', 'timeFrame': 'up 1 hour after catheter placement', 'description': 'The duration necessary to ascertain the optimal filling volume of the esophageal catheter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure (ARF)', 'esophageal catheter', 'transpulmonary pressure'], 'conditions': ['Pediatric Acute Respiratory Distress Syndrome (PARDS)', 'Acute Respiratory Failure', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '25634481', 'type': 'BACKGROUND', 'citation': 'Mojoli F, Chiumello D, Pozzi M, Algieri I, Bianzina S, Luoni S, Volta CA, Braschi A, Brochard L. Esophageal pressure measurements under different conditions of intrathoracic pressure. An in vitro study of second generation balloon catheters. Minerva Anestesiol. 2015 Aug;81(8):855-64. Epub 2015 Jan 30.'}, {'pmid': '29089460', 'type': 'BACKGROUND', 'citation': 'Hotz JC, Sodetani CT, Van Steenbergen J, Khemani RG, Deakers TW, Newth CJ. Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS. Respir Care. 2018 Feb;63(2):177-186. doi: 10.4187/respcare.05685. Epub 2017 Oct 31.'}, {'pmid': '27063290', 'type': 'BACKGROUND', 'citation': 'Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.'}]}, 'descriptionModule': {'briefSummary': "Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes).\n\nHowever, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters.\n\nTo address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients between 1 months and 18 years\n* Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours\n* Informed consent was signed by next of kin\n* Requiring esophageal catheter application\n\nExclusion Criteria:\n\n* Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours\n* Patient included in another interventional study in the last 30 days\n* Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies\n* Patient included in another interventional research study under consent\n* Patient already enrolled in the present study in a previous episode of acute respiratory failure'}, 'identificationModule': {'nctId': 'NCT06051292', 'acronym': 'DECFVTTPM', 'briefTitle': 'Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement', 'organization': {'class': 'OTHER', 'fullName': "Dr. Behcet Uz Children's Hospital"}, 'officialTitle': 'Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement', 'orgStudyIdInfo': {'id': '02020395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fast decremental', 'description': 'fast decremental catheter volume titration will be applied', 'interventionNames': ['Other: Fast method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'conventional catheter volume titration will be applied', 'interventionNames': ['Other: Conventional method']}], 'interventions': [{'name': 'Fast method', 'type': 'OTHER', 'description': 'Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements', 'armGroupLabels': ['Fast decremental']}, {'name': 'Conventional method', 'type': 'OTHER', 'description': 'Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09020', 'city': 'Aydin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ekin soydan', 'role': 'CONTACT', 'email': 'dr-ekinsoydan@hotmail.com', 'phone': '+905321003949'}], 'facility': 'Aydin Obstetric and pediatrics Hospital', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'zip': '25180', 'city': 'Erzurum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Pinar Hepduman, MD', 'role': 'CONTACT', 'email': 'pnrhpdmn@gmail.com', 'phone': '+905531501115'}], 'facility': 'Erzurum Regional Research and Training Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}, {'zip': '34001', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mustafa Colak, MD', 'role': 'CONTACT', 'email': 'colakk@hotmail.com', 'phone': '+905554180903'}], 'facility': 'Cam Sakura Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35200', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ozlem Sandal, MD', 'role': 'CONTACT', 'email': 'drozlemsarac@hotmail.com', 'phone': '+905067644688'}, {'name': 'Ozlem Sandal', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gulhan Atakul', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Hasan Agin, Professor', 'role': 'CONTACT', 'email': 'hasanagin@gmail.com', 'phone': '05362013162'}, {'name': 'Gokhan Ceylan, Associate Professor', 'role': 'CONTACT', 'email': 'drgokhanceylan@gmail.com', 'phone': '0794542397'}], 'overallOfficials': [{'name': 'Hasan Agin, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Behcet Uz Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Behcet Uz Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hasan ağın', 'investigatorAffiliation': "Dr. Behcet Uz Children's Hospital"}}}}