Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-03-28 @ 6:07 PM
Study NCT ID:
NCT06638658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and hair.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-10-05', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain scores of movement-evoked pain', 'timeFrame': 'During hospitalization', 'description': 'Assessed using NRS scale and BPI at different time points after surgery'}, {'measure': 'Pain scores at rest', 'timeFrame': 'During hospitalization', 'description': 'Using NRS scale and BPI at different time points after surgery'}, {'measure': 'Surgical site infection', 'timeFrame': 'During hospitalization', 'description': 'Defined according to the European Perioperative Clinical Outcome (EPCO) criteria'}, {'measure': 'Time of Bowel function recovery', 'timeFrame': 'During hospitalization', 'description': 'Defined as time to first defecation or flatus'}, {'measure': 'Sleep quality after surgery', 'timeFrame': 'Up to 1 year postoperatively', 'description': 'Assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Morningness-Eveningness Questionnaire (MEQ) at different time points after surgery'}, {'measure': 'Postoperative anxiety assessment', 'timeFrame': 'Up to 1 year postoperatively', 'description': 'Assessed using GAD-7 scores at different time points after surgery'}, {'measure': 'Postoperative depression assessment', 'timeFrame': 'Up to 1 year postoperatively', 'description': 'Assessed using PHQ-9 scores at different time points after surgery'}, {'measure': 'Postoperative cognitive function assessment', 'timeFrame': 'Up to 1 year postoperatively', 'description': 'Assessed using AD-8 and three-word recall test scores at different time points after surgery'}], 'primaryOutcomes': [{'measure': 'Postoperative venous thromboembolism', 'timeFrame': 'During hospitalization', 'description': 'Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.'}], 'secondaryOutcomes': [{'measure': 'Postoperative venous thromboembolism', 'timeFrame': 'Up to 2 weeks postoperatively', 'description': 'Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.'}, {'measure': 'A composite of postoperative pulmonary complications', 'timeFrame': 'During hospitalization', 'description': 'Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia.'}, {'measure': 'Postoperative major adverse cardiovascular events', 'timeFrame': 'During hospitalization', 'description': 'Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmias, angina, et al.'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'During hospitalization', 'description': 'Nausea and vomiting'}, {'measure': 'The quality of postoperative recovery', 'timeFrame': 'During hospitalization', 'description': 'Assessed using QoR-15 score at different time points after surgery'}, {'measure': 'Chronic pain after surgery', 'timeFrame': 'Up to 1 year postoperatively', 'description': 'Assessed using NRS scale and BPI at different time points after surgery'}, {'measure': 'Postoperative quality of life assessment', 'timeFrame': 'Up to 1 year postoperatively', 'description': 'Assessed using WHODAS2.0 scores at different time points after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High-altitude population', 'Perioperative cohort', 'Orthopedic surgery'], 'conditions': ['Orthopedic Surgery', 'Postoperative Complications', 'High Altitude']}, 'descriptionModule': {'briefSummary': 'This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.', 'detailedDescription': 'Prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. This elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. This study will focus on orthopedic surgery patients from high-altitude regions. Using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. Regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. Additionally, perioperative data such as electronic medical records, laboratory test results, ECG waveforms, echocardiography, chest CT images, and other pertinent records will be also collected. Through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have lived in high-altitude regions scheduled for orthopedic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. ASA classification I-III;\n3. Patients who have lived at an altitude above 2500 meters for more than 6 months ;\n4. Patients scheduled for elective orthopedic surgery.\n\nExclusion Criteria:\n\n1. Urgent or emergent surgery;\n2. Expected hospital stay \\< 48 hours;\n3. Inability to provide informed consent；\n4. Patients who have been out of high-altitude regions for over three months.'}, 'identificationModule': {'nctId': 'NCT06638658', 'briefTitle': 'Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.', 'orgStudyIdInfo': {'id': '20241284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthopedic surgery patients from high-altitude regions', 'description': 'high altitude patients Undergoing orthopedic surgery'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chunling Jiang, PhD', 'role': 'CONTACT', 'email': 'jiangchunling@scu.edu.cn', 'phone': '+86 02885422114'}, {'name': 'Fengming Luo, phD', 'role': 'CONTACT', 'email': 'jiangchunling@scu.edu.cn', 'phone': '+86 85423593'}], 'overallOfficials': [{'name': 'Chunling Jiang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chunling Jiang', 'investigatorAffiliation': 'West China Hospital'}}}}