Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04725318
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esophageal Pressure Measurements During One-lung Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-17', 'releaseDate': '2025-11-03'}], 'estimatedResultsFirstSubmitDate': '2025-11-03'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D061810', 'term': 'One-Lung Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esophageal pressure at lung collapse', 'timeFrame': 'During one-lung ventilation', 'description': 'Esophageal pressure during one-lung ventilation in the lateral position at beginning lung collapse as measured by electrical impedance tomography during a decremental PEEP titration'}], 'secondaryOutcomes': [{'measure': 'Esophageal Pressure', 'timeFrame': 'During one-lung ventilation', 'description': 'Esophageal Pressure during one-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves'}, {'measure': 'Esophageal Pressure', 'timeFrame': 'During two-lung ventilation in the lateral position', 'description': 'Esophageal Pressure during two-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves'}, {'measure': 'Esophageal Pressure', 'timeFrame': 'During two-lung ventilation in the supine position', 'description': 'Esophageal Pressure during two-lung ventilation in the supine position at airway closure as assessed by pressure-volume curves'}, {'measure': 'Optimum PEEP', 'timeFrame': 'During one-lung ventilation', 'description': 'PEEP during PEEP titration that provides optimum trade-off between lung collapse and overdistension, as measured by Electrical Impedance Tomography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['One-lung ventilation', 'Electrical Impedance Tomography', 'Thoracic Surgery', 'Esophageal manometry', 'Transpulmonary Pressure', 'Lung-protective ventilation'], 'conditions': ['Surgery', 'One-lung Ventilation']}, 'descriptionModule': {'briefSummary': 'The investigators will assess the feasibility and validity of esophageal pressure measurements during one-lung ventilation in the lateral position for surgery by comparing to lung collapse estimated from electrical impedance tomography during a PEEP trial.', 'detailedDescription': 'In this prospective cohort study, the investigators will assess the feasibility of esophageal pressure measurements during general anesthesia with one-lung ventilation in patients undergoing non-cardiac intrathoracic surgery, which is typically conducted in the lateral position. The investigators will measure esophageal pressure with an esophageal balloon catheter. The investigators will compare esophageal pressure measurements to lung collapse estimated by Electrical Impedance Tomography (EIT).\n\nPatients will be equipped with the EIT belt before induction of anesthesia, and a one-minute EIT recording during spontaneous breathing will be conducted. Anesthesia will be induced as to institutional standards and upon the discretion of the attending anesthesiologist. After placement of a double-lumen endotracheal tube, the esophageal balloon catheter will be placed.\n\n* After placement of the esophageal catheter, esophageal pressure, transpulmonary pressure, airway pressure and flow and EIT signal will be recorded ("baseline").\n* When the patient has been positioned for surgery (typically in the lateral position), a second recording of the above parameters is conducted ("lateral"). One-lung ventilation will then be initiated and a third measurement ("OLV") is made.\n* During the third measurement, a decremental positive end-expiratory pressure trial will be conducted to correlate the measured esophageal pressure to the positive end-expiratory pressure where lung collapse is detected from EIT.\n* Before surgery, the EIT belt is opened and removed from the surgical field to avoid interference.\n* If feasible, when surgery is finished, before reversal of neuromuscular blockade and extubation, a final recording of EIT, esophageal pressure, transpulmonary pressure, airway pressure and flow will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing non-cardiac surgery requiring one-lung ventilation under general anesthesia as part of clinical routine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing non-cardiac surgery with OLV\n\nExclusion Criteria:\n\n* COPD\n* Active respiratory infection\n* Prior lung resection\n* Prior esophageal/gastric surgery\n* Esophageal varices\n* Patients under effective anticoagulation at time of surgery\n* Pacemaker/ICD\n* Pregnancy\n* Inability to give written informed consent'}, 'identificationModule': {'nctId': 'NCT04725318', 'briefTitle': 'Esophageal Pressure Measurements During One-lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation', 'orgStudyIdInfo': {'id': '2020P-000811'}}, 'armsInterventionsModule': {'interventions': [{'name': 'One-lung ventilation', 'type': 'OTHER', 'description': 'One-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maximilian S Schaefer, MD', 'role': 'CONTACT', 'email': 'msschaef@bidmc.harvard.edu', 'phone': '617 632 0728'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Maximilian S Schaefer, MD', 'role': 'CONTACT', 'email': 'msschaef@bidmc.harvard.edu', 'phone': '317 306 3216'}, {'name': 'Elias Baedorf-Kassis, MD', 'role': 'CONTACT', 'email': 'enbaedor@bidmc.harvard.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesia', 'investigatorFullName': 'Maximilian S Schaefer', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-03', 'type': 'RELEASE'}, {'date': '2025-11-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maximilian S Schaefer, Associate Professor of Anaesthesia, Beth Israel Deaconess Medical Center'}}}}