Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT06041750
Status:
UNKNOWN
Last Update Posted:
2023-09-18
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pulmonary complications', 'timeFrame': 'Postoperative day 1, 2, 7 and 30.', 'description': 'The rate of postoperative hypoxia (respiratory failure), atelectasis, pulmonary edema /embolus, aspiration, bronchospasm, respiratory infection / pneumonia, pleural effusion, pneumothorax, respiratory arrest will be measured'}], 'secondaryOutcomes': [{'measure': 'Predictive factors', 'timeFrame': 'Postoperative day 1, 2, 7 and 30.', 'description': 'Determination of patient, anesthesia and surgery-related predictive factors affecting the development of postoperative pulmonary complications.'}, {'measure': 'Non-invasive/invasive mechanical ventilation requirement', 'timeFrame': 'Postoperative day 1, 2, 7 and 30.', 'description': 'Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards.'}, {'measure': 'Intensive care unit admission', 'timeFrame': 'Postoperative day 1, 2, 7 and 30.', 'description': 'Intensive care unit admission for respiratory indication'}, {'measure': 'Mortality', 'timeFrame': 'Postoperative day 30.', 'description': 'Mortality rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'postoperative pulmonary complications', 'general anesthesia'], 'conditions': ['Obstructive Sleep Apnea', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'It is known that perioperative respiratory complications occur more often in obstructive sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are prospective RCTs in this area, the need for further and larger studies remains due to the heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the respiratory adverse events are uncertain. Therefore, in this prospective observational cohort study, it was aimed to determine the incidence of postoperative pulmonary complications and the predictor factors associated with patient, anesthesia and surgery in surgical patients with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ASA status I-III adult patients age between 18-65 years undergoing elective surgery with general anesthesia and diagnosis of OSAS will be recruited in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-65 years\n2. ASA physical status I-III\n3. Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)\n4. Surgeries performed under general anesthesia\n5. Endotracheal intubation facilitated by neuromuscular blockers\n\nExclusion Criteria:\n\n1. ASA physical status IV or V\n2. Planned admission to the ICU after surgery\n3. Cardiac Surgery\n4. Non-operating room anesthesia\n5. Neuromuscular disease\n6. Emergency or re-operational procedure\n7. Laryngectomy\n8. Pneumonectomy\n9. Invasive airway access\n10. Pregnancy\n11. Outpatient surgery'}, 'identificationModule': {'nctId': 'NCT06041750', 'briefTitle': 'Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study', 'orgStudyIdInfo': {'id': 'POPCSA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSAS patients with postoperative pulmonary complication', 'description': 'American Society of Anesthesiologists (ASA) physical status I-III adult patients age between 18-65 years undergoing elective surgery with general anesthesia and diagnosis of OSAS will be recruited in this study. In this patient group, the incidence of postoperative early-period and long-term pulmonary complications will be investigated.', 'interventionNames': ['Procedure: Elective surgical procedure under general anesthesia']}], 'interventions': [{'name': 'Elective surgical procedure under general anesthesia', 'type': 'PROCEDURE', 'description': 'The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.', 'armGroupLabels': ['OSAS patients with postoperative pulmonary complication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01100', 'city': 'Adana', 'state': 'Sariçam', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'centralContacts': [{'name': 'Çiğdem Tütüncü, Prof. Dr.', 'role': 'CONTACT', 'email': 'actutuncu@gmail.com', 'phone': '+905325920584'}, {'name': 'Demet Laflı Tunay, Dr.', 'role': 'CONTACT', 'email': 'dlafli@yahoo.com', 'phone': '+905358685831'}], 'overallOfficials': [{'name': 'Çiğdem Tütüncü, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'İstanbul University, Cerrahpaşa, Faculty of Medicine'}, {'name': 'Demet Laflı Tunay, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Çukurova University, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "All data will be anonymized by the local researcher. Therefore, data collection will be pseudonymous and the patient's name will not appear on any case report form or other study document. All collected data will be kept confidential. This study will be conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP will be strictly adhered to."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, {'name': 'Acibadem University', 'class': 'OTHER'}, {'name': 'Baskent University', 'class': 'OTHER'}, {'name': 'Celal Bayar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Demet Laflı Tunay', 'investigatorAffiliation': 'Cukurova University'}}}}