Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 10:11 AM
Study NCT ID:
NCT06705894
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2024-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care: A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011015', 'term': 'Pneumonia, Aspiration'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10313}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2024-11-23', 'studyFirstSubmitQcDate': '2024-11-23', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative cough', 'timeFrame': '24 hours after surgery', 'description': 'The investigator needs to use NRS scores to evaluate the severity of the cough, if patients develop a new cough after surgery.The score from 0 (no) to 10 (extremely serious).Duration and treatment are also required to be recorded.'}, {'measure': 'Postoperative fever', 'timeFrame': '24 hours after surgery', 'description': "The investigator needs to record the patient's maximum body temperature. Duration and treatment are also required to be recorded."}, {'measure': 'Short of breath', 'timeFrame': '24 hours after surgery', 'description': 'The investigator needs to use mMRC questionnaire to evaluate the severity of SOB.Duration and treatment are also required to be recorded.'}], 'secondaryOutcomes': [{'measure': 'Adverse events during surgery', 'timeFrame': 'During surgery', 'description': 'Adverse events such as coughing, reflux aspiration, laryngeal spasm, and hypotension need to be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal endoscopy', 'Respiratory complications', 'Sedation'], 'conditions': ['Pneumonia, Aspiration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.', 'detailedDescription': 'Gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.With the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.The painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.However, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;\n\nExclusion Criteria:\n\n1. Patients with respiratory system symptoms or history before surgery;\n2. Patients in need of a tracheal intubation;\n3. Refuse follow-up;'}, 'identificationModule': {'nctId': 'NCT06705894', 'briefTitle': 'Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care: A Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'QYFYEC2024-218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'M group', 'description': 'Gratrointestinal endoscopy is undergone with moderate sedation.'}, {'label': 'D/G group', 'description': 'Gratrointestinal endoscopy is undergone without deep sedation/general anesthsia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '266000', 'city': 'Qingdao', 'state': 'Shangdong', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'jixiangyu', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}