Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04879602
Status:
UNKNOWN
Last Update Posted:
2023-02-21
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Suctioning by Bronchoscope on Postoperative Pulmonary Complications Among Patients With SCI in the PACU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013396', 'term': 'Suction'}, {'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of postoperative pulmonary complications', 'timeFrame': 'within 7 days after operation or before discharge, whichever came first', 'description': 'postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis\n\nincluding respiratory infection, respiratory failure,pleural effusion, atelectasis, pneumothorax , broncospasm and aspiration pneumonitis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Respiratory failure and dyspnea are common in spinal cord injury (SCI), and in acute situations, any spinal cord lesion above T11 can cause abnormal respiratory function and impair the airway clearance.\n\nAlthough surgical decompression is one of the key early neuroprotective therapies, surgery and general anesthesia disrupt many aspects of respiratory function and may cause a series of postoperative pulmonary complications.\n\nEndotracheal suction is important to reduce the risk of lung consolidation and atelectasis. But for patients with respiratory insufficiency such as SCI, ordinary suction is not enough to clear secretions in the deeper airways. And repeated intratracheal suction may even cause some serious complications.\n\nBronchoscopy can generally penetrate into the bronchus of grade 3-4, and fully attract the secretions in it under visual conditions. Its curative effect on pneumonia and atelectasis in the ICU has been affirmed, but no one has yet explored the application in the postoperative care unit .', 'detailedDescription': 'All patients admitted to PACU with tracheal tube after operation will be recruited, and than be randomly divided into two groups during resuscitation:\n\n1. one group receives routine ordinary sputum suction ; the other group receives routine ordinary sputum suction with bronchoscopy\n2. After entering the PACU, both groups will receive two lung ultrasound examinations and record the lung ultrasound scores: when entering PACU and when leaving PACU.\n\nAfter returning to the ward, the doctor in charge will make medical decisions and treatments based on the condition.\n\nFollow up for pulmonary complications (respiratory tract infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, pulmonary edema, pulmonary embolism, aspiration pneumonia) within 7 days after surgery.\n\nFollow-up 30 days and 90 days after operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age\\>=18 Spinal injury level :above T11 Stable preoperative spontaneous respiration Elective cervical/thoracic spine fixation American Spinal Injury Association (ASIA) class: A-D\n\nExclusion Criteria:\n\n\\- Unconscious before surgery Pregnant With mental disorders Directly transfered to ICU'}, 'identificationModule': {'nctId': 'NCT04879602', 'briefTitle': 'Effect of Suctioning by Bronchoscope on Postoperative Pulmonary Complications Among Patients With SCI in the PACU', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Second Affiliated Hospital of Zhejiang University,School of Medicine', 'orgStudyIdInfo': {'id': '2021-0162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bronchoscopy group', 'description': 'patients receive suction before extubation by bronchoscopy in PACU', 'interventionNames': ['Behavioral: suction with bronchoscopy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'patients receive routine ordinary suction in PACU'}], 'interventions': [{'name': 'suction with bronchoscopy', 'type': 'BEHAVIORAL', 'description': 'suction with bronchoscopy', 'armGroupLabels': ['Bronchoscopy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan, Doctor', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '15888210247'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University Medical College', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Yan, MD', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '13757118632'}], 'overallOfficials': [{'name': 'Min Yan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}