[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660029":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":34,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":76,"collaborators":24,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":24,"maxAge":87,"enrollmentInfo":88,"targetDuration":91,"studyType":92,"phases":24,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":103,"whyStopped":24,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Mersin University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":20},[9,12],{"measure":10,"description":10,"timeFrame":11},"Measurement of end-tidal carbon dioxide levels using a nasal capnography device","From enrollment to the end of treatment at one weeks",{"measure":13,"description":14,"timeFrame":11},"Enhancing safety in diagnostic bronchoscopy for foreign body aspiration in children","Enhancing the safety of bronchoscopy performed for suspected foreign body aspiration in children.",[16],{"measure":17,"description":18,"timeFrame":19},"Changes during a postoperative follow-up period averaging one week in patients undergoing diagnostic bronchoscopy for suspected foreign body aspiration.","The effects of whether end-tidal carbon dioxide values measured using nasal capnography in the study participants exceed the reference range of 35-45 mmHg on treatment management will be evaluated.","From November 2026 to November 2027",[21],{"measure":22,"description":22,"timeFrame":19},"Data will be collected from all cases within the specified study period, and post hoc assessments will be performed upon completion of data collection.",{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":25,"timePerspective":26,"maskingInfo":24},null,"CASE_CROSSOVER","CROSS_SECTIONAL","Introduction Despite advances in diagnosis and treatment, foreign body aspiration remains a common and clinically relevant health problem among children. The mortality rate associated with foreign body aspiration in children has been reported to range from 1% to 5%. Diagnostic bronchoscopy remains the gold standard for confirming the diagnosis of foreign body aspiration and providing definitive treatment. In clinical practice, indications for bronchoscopy are determined based on the history provided by the family, physical examination findings, and radiological investigations. However, 16%-57% of bronchoscopies performed in children with suspected foreign body aspiration may result in negative exploration. Furthermore, among children presenting to the emergency department with a history suggestive of foreign body aspiration, 27% have no respiratory symptoms and 20% have no abnormal physical examination findings. During bronchoscopy performed under general anesthesia for foreign body aspiration, respiratory distress and oxygenation problems may also occur because of inflammation, secretions, or granulation tissue caused by the foreign body. Consequently, post-bronchoscopy respiratory complications requiring intensive care monitoring may develop in 6.3% of patients. Given these risks, the use of scoring systems based on preprocedural physical examination and radiological findings to determine bronchoscopy indications remains an active area of research.\n\nFor these reasons, in addition to determining the indication for bronchoscopy based on the available clinical and radiological findings, predicting potential intraoperative complications appears to be important in children with suspected foreign body aspiration. Accordingly, assessing both the likelihood of a positive bronchoscopy and the adequacy of ventilation before the procedure may improve the safety of bronchoscopy in these patients.\n\nCapnography enables the noninvasive assessment of ventilation by measuring end-tidal carbon dioxide levels in intubated patients receiving mechanical ventilation. Nasal capnography is used particularly during procedures performed under sedation and analgesia in which spontaneous breathing is maintained, allowing respiratory depression and associated hypercapnia to be detected and thereby improving procedural safety. A particular advantage of nasal capnography is its ability to identify mild hypercapnia that may not be reflected by pulse oximetry, as well as to facilitate the early detection of serious respiratory compromise. Therefore, preprocedural nasal capnographic assessment in patients scheduled to undergo diagnostic bronchoscopy for suspected foreign body aspiration may help predict potential intraoperative complications and facilitate appropriate preparation for interventions such as respiratory support. Taken together, these considerations suggest that the noninvasive assessment of ventilatory status using nasal capnography before bronchoscopy may be a clinically relevant parameter for both improving procedural safety and predicting positive bronchoscopic findings in children with suspected foreign body aspiration.\n\nThis study aimed to evaluate the associations of preprocedural nasal capnographic assessment with positive and negative bronchoscopic exploration findings and with intraoperative complications in children undergoing bronchoscopy for suspected foreign body aspiration.\n\nMethods Approval was obtained from the Mersin University Health Sciences Ethics Committee (2026\u002F556). The study, including the data collection phase, is planned to be completed within 12 months following the date of ethics committee approval. The ethics committee application indicated that an application would be submitted to the Mersin University Scientific Research Projects (BAP) Unit for funding. In the ethics committee application, the study period was defined as one year following approval by the BAP Unit. Data collection will commence after the nasal capnography device has been procured within the scope of the project.\n\nChildren aged 0-18 years who are scheduled to undergo rigid bronchoscopy for suspected foreign body aspiration at the Department of Pediatric Surgery of Mersin University Hospital during the specified study period are planned to be included. Patients undergoing procedures performed by Assoc. Prof. Caner İsbir, Dr. Hatice Büyüköztürk Çolak, or Dr. Mert Jundi during the data collection period will be considered for inclusion. Data collection will be conducted with the participation of all investigators. The collected data will be analyzed by Assoc. Prof. Caner İsbir and Dr. Hatice Büyüköztürk Çolak.\n\nPatients presenting with suspected foreign body aspiration whose legal guardians decline rigid bronchoscopy, those whose legal guardians do not sign the informed consent forms prepared for the study, and those whose nasal capnographic measurements cannot be recorded because of technical problems will be excluded from the study.\n\nIn patients admitted to the pediatric surgery ward with suspected foreign body aspiration, end-tidal carbon dioxide (ETCO₂) levels will be measured using a capnography device connected to a nasal cannula during preoperative preparation in the ward before rigid bronchoscopy. The measurements will be recorded numerically for each patient. ETCO₂ values will also be categorized into two groups: values within the range of 35-45 mmHg and values above this range.\n\nThe variables to be evaluated will include age, sex, body weight, weight-for-age percentile, preoperative pulse oximetry values, preoperative clinical symptoms, physical examination findings, radiological findings, and postoperative complications following bronchoscopy. Patients will be divided into three age groups: 0-6, 6-12, and 12-18 years. In addition, the associations between nasal capnographic measurements and positive or negative bronchoscopic exploration findings, intraoperative complications, and postoperative complications will be investigated.\n\nThe associations of positive or negative bronchoscopic exploration findings and intraoperative\u002Fpostoperative complications with preoperative capnographic assessment results will be analyzed using the independent-samples t test and chi-square test, as appropriate. Furthermore, logistic regression analysis will be performed to evaluate the associations between nasal capnographic measurements in the specified age groups and positive or negative bronchoscopic exploration findings, as well as intraoperative and postoperative complications.","The study is planned as a single-center investigation. The study population will consist of patients presenting with foreign body aspiration to the Department of Pediatric Surgery, Faculty of Medicine, Mersin University.",[30],{"label":31,"type":24,"description":31,"interventionNames":32},"Children with foreign body aspiration",[33],"Diagnostic Test: Nasal capnographic examination",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":24},"DIAGNOSTIC_TEST","Nasal capnographic examination","Measurement of end-tidal carbon dioxide levels using a nasal capnography device.",[31],[41],{"name":42,"affiliation":43,"role":44},"Caner İsbir, Associate Professor","Department of Pediatric Surgery, Faculty of Medicine, Mersin University, Türkiye","STUDY_CHAIR",[46,50],{"name":42,"role":47,"phone":48,"phoneExt":24,"email":49},"CONTACT","+905316014260","caner.isbir@gmail.com",{"name":51,"role":47,"phone":52,"phoneExt":24,"email":53},"Hatice Büyüköztürk Çolak, Medical Doctor","+905331673136","haticebuyukozturk@hotmail.com",[55],{"facility":56,"status":24,"city":57,"state":58,"zip":59,"country":60,"countryCode":24,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Department of Pediatric Surgery, Faculty of Medicine, Mersin University, Mersin, Turkey","Mersin","Yenişehir","33160","Turkey (Türkiye)",{"type":62,"coordinates":63},"Point",[64,65],34.63886,36.81196,{"lat":65,"lon":64},[68,69,70,72,74],{"name":42,"role":47,"phone":48,"phoneExt":24,"email":49},{"name":51,"role":47,"phone":52,"phoneExt":24,"email":53},{"name":42,"role":71,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"name":51,"role":73,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":75,"role":73,"phone":24,"phoneExt":24,"email":24},"Mert Jundi, Medical Doctor",{"type":71,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Caner İsbir","associate professor","100660029","the-impact-of-preoperative-nasal-capnography-on-clinical-management-in-patients-undergoing-diagnostic-bronchoscopy-for-suspected-foreign-body-aspiration-100660029",false,"NCT07870005","The Impact of Preoperative Nasal Capnography on Clinical Management in Patients Undergoing Diagnostic Bronchoscopy for Suspected Foreign Body Aspiration","Capnography","Inclusion Criteria:\n\n* Patients scheduled to undergo rigid bronchoscopy for foreign body aspiration at the Department of Pediatric Surgery, Mersin University Hospital, between 1 November 2026 and 1 November 2027.\n* Children aged 0-18 years.\n* Patients whose parents or legal guardians have signed the informed consent forms prepared for the study.\n* Patients for whom complete data, including nasal capnography measurements, can be collected.\n\nExclusion Criteria:\n\n* Patients presenting with foreign body aspiration outside the period from 1 November 2026 to 1 November 2027.\n* Patients who decline rigid bronchoscopy.\n* Patients whose legal guardians have not signed the informed consent forms prepared for the study.\n* Patients whose nasal capnography measurements cannot be recorded due to technical difficulties or whose other data cannot be collected in full.","ALL","18 Years",{"count":89,"type":90},45,"ESTIMATED","5 Days","OBSERVATIONAL","Introduction Despite advances in medical care, foreign body aspiration remains a common and ongoing health concern in children. Diagnostic bronchoscopy is the gold standard for confirming the diagnosis and providing definitive treatment. However, bronchoscopy performed for suspected foreign body aspiration in children yields negative findings in 16-57% of cases. Furthermore, oxygenation problems may occur during bronchoscopy performed under general anesthesia for foreign body aspiration. Respiratory complications requiring intensive care monitoring may develop in 6.3% of patients following bronchoscopy. These risks underscore the importance of preoperative assessment. In children with suspected foreign body aspiration, preoperative nasal capnography may complement clinical and radiological findings in determining the indications for bronchoscopy and predicting potential intraoperative complications.\n\nCapnography assesses oxygenation status by measuring end-tidal carbon dioxide concentrations. Nasal capnography is used particularly during sedation and analgesia when spontaneous breathing is maintained. In patients scheduled for diagnostic bronchoscopy for suspected foreign body aspiration, preoperative capnographic assessment may help predict complications occurring during and after the procedure.\n\nThis study aims to evaluate the association of preoperative nasal capnographic measurements with positive and negative bronchoscopic findings and potential intraoperative complications in children with foreign body aspiration.\n\nMethods Ethical approval was obtained from the Mersin University Health Sciences Ethics Committee (2026\u002F556). The study, including data collection, is planned to be completed within 12 months of ethical approval. The ethics application stated that an application for project funding would be submitted to the Mersin University Scientific Research Projects (BAP) Unit. The study period was specified in the ethics application as one year following approval by the BAP Unit. Data collection will commence after the nasal capnography device has been procured through the project.\n\nChildren aged 0-18 years undergoing rigid bronchoscopy for foreign body aspiration at the Department of Pediatric Surgery, Mersin University Hospital, during the specified study period will be eligible for inclusion. Patients operated on by Associate Professor Caner İsbir, Dr. Hatice Büyüköztürk Çolak, or Dr. Mert Jundi will be included. All investigators will participate in data collection, and the collected data will be analyzed by Associate Professor Caner İsbir and Dr. Hatice Büyüköztürk Çolak.\n\nPatients presenting with foreign body aspiration during the study period will be excluded if they decline rigid bronchoscopy, if their legal guardians do not sign the study-specific informed consent forms, or if nasal capnographic measurements cannot be recorded because of technical difficulties.\n\nIn patients admitted to the pediatric surgery ward with suspected foreign body aspiration, end-tidal carbon dioxide (ETCO₂) will be measured using a capnography device connected to a nasal cannula during preoperative preparation on the ward, before rigid bronchoscopy. Measurements will be recorded numerically for each patient. ETCO₂ values will also be classified into two groups: values up to and including the 35-45 mmHg range and values above this range.\n\nThe following variables will be assessed: age, sex, body weight, weight percentiles, preoperative pulse oximetry readings, preoperative clinical symptoms, physical examination findings, radiological findings, and postoperative complications following bronchoscopy. Patients will be categorized into three age groups: 0-6, 6-12, and 12-18 years.\n\nThe associations between nasal capnographic measurements and positive or negative bronchoscopic findings, as well as intraoperative and postoperative complications, will be examined. Independent-samples t-tests and chi-square tests will be used to assess the associations of preoperative capnographic measurements with bronchoscopic findings and intraoperative and postoperative complications. Logistic regression analysis will additionally be used to examine the associations of nasal capnographic measurements within the specified age groups with positive or negative bronchoscopic findings and intraoperative and postoperative complications.",[95],"Foreign Body Aspiration in Children",[97,98,99,100,101,102],"Foreign body aspiration","bronchoscopy","capnography","predictive value","children","complications","NOT_YET_RECRUITING","2026-10-06",{"date":106,"type":107},"2026-10-13","ACTUAL",{"date":109,"type":90},"2026-11-01",{"date":111,"type":90},"2027-12-01",{"name":5,"class":6},1]