Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:37 PM
Study NCT ID:
NCT07100860
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Single Lung Ventilation Duration on Postoperative Pulmonary Complications in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postopertive Pulmonary Complications', 'timeFrame': 'postoperative 7 days', 'description': 'Postoperative pulmonary complications (PPCs) are defined as respiratory events occurring within the first seven days following thoracic surgery, which negatively impact patient outcomes. In this study, PPCs include pneumonia, pneumothorax, hemothorax, acute lung injury, acute respiratory distress syndrome (ARDS), prolonged oxygen requirement, unplanned reintubation, and the need for non-invasive ventilation. These complications will be identified through clinical assessment, arterial blood gas analysis, and postoperative imaging such as chest X-rays. Each case will be evaluated using predefined diagnostic criteria to ensure consistency. The incidence of PPCs will be analyzed in relation to the duration of intraoperative single-lung ventilation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pulmonary complications', 'one lung ventilation'], 'conditions': ['Postoperative Pulmonary Complications', 'One Lung Ventilation', 'Ards', 'Postoperative Pulmonary Atelectasis']}, 'referencesModule': {'references': [{'pmid': '28186222', 'type': 'BACKGROUND', 'citation': 'Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.'}, {'pmid': '27392439', 'type': 'BACKGROUND', 'citation': 'Kiss T, Bluth T, Gama de Abreu M. [Does intraoperative lung-protective ventilation reduce postoperative pulmonary complications?]. Anaesthesist. 2016 Aug;65(8):573-9. doi: 10.1007/s00101-016-0198-8. German.'}]}, 'descriptionModule': {'briefSummary': 'This observational study investigates the relationship between the duration of single-lung ventilation (SLV) and the incidence of postoperative pulmonary complications (PPCs) such as pneumonia, pneumothorax, hemothorax, acute lung injury, and acute respiratory distress syndrome (ARDS) in adult patients undergoing thoracic surgery. A total of 134 patients aged 18-85 years, scheduled for thoracic surgery requiring SLV, will be monitored. Data including SLV duration, perioperative parameters, and postoperative pulmonary outcomes will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients aged 18 to 85 years who are scheduled to undergo thoracic surgery at Etlik City Hospital and require OLV during the procedure. Patients will be included if they meet the eligibility criteria of being over 18 years old, undergoing thoracic surgery, receiving intraoperative OLV, and providing informed consent to participate in the study. Patients will be excluded if they are part of the pediatric age group, do not require OLV, or decline participation. A total of 134 eligible patients will be prospectively enrolled and followed for seven days postoperatively to assess the occurrence of pulmonary complications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge ≥18 years Undergoing thoracic surgery OLV planned during the procedure\n\nExclusion Criteria:\n\nPediatric patients Patients not requiring OLV Previous thoracic surgery'}, 'identificationModule': {'nctId': 'NCT07100860', 'briefTitle': 'The Effect of Single Lung Ventilation Duration on Postoperative Pulmonary Complications in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'Does Duration Matter? A Study on Single-Lung Ventilation Time and Pulmonary Complications in Thoracic Procedures', 'orgStudyIdInfo': {'id': 'OLV_PPC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'One-Lung ventilation', 'type': 'PROCEDURE', 'description': 'In this observational study, the naturally occurring duration of intraoperative single-lung ventilation (SLV) during thoracic surgery will be recorded. No intervention is applied or modified for research purposes. The exposure of interest is the total duration (in minutes) of SLV, which will be timed from initiation to termination during surgery. This variable will be analyzed in relation to postoperative pulmonary complications.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06810', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hazal EG AYTUĞ', 'role': 'CONTACT', 'email': 'drekinguran@gmail.com', 'phone': '05078448449'}], 'facility': 'Hazal Ekin GÜRAN AYTUĞ', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Hazal EG AYTUĞ', 'role': 'CONTACT', 'email': 'drekinguran@gmail.com', 'phone': '05078448449'}], 'overallOfficials': [{'name': 'Hazal EG AYTUĞ', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Consultant Anesthesiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesiologist', 'investigatorFullName': 'Ekin Guran, MD', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}