Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 2:50 PM
Study NCT ID:
NCT03711461
Status:
UNKNOWN
Last Update Posted:
2019-09-18
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Between NIVATS and Intubated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the swallowing function assessor is blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'intubated and nonintubated patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2023-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impedance changes', 'timeFrame': 'average 4 hours', 'description': 'using esophageal manometry to evaluate the swallowing'}], 'secondaryOutcomes': [{'measure': 'esophageal pressure changes', 'timeFrame': 'average 4 hours', 'description': 'using esophageal manometry to evaluate the swallowing'}, {'measure': 'hyoid bone distance', 'timeFrame': 'average 4 hours', 'description': 'using ultrasound to evaluate the swallowing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Function in Thoracoscopy']}, 'descriptionModule': {'briefSummary': 'the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography', 'detailedDescription': 'Background: Anesthetic agents alter pharyngeal function with risk of impaired airway protection and aspiration. The pharyngeal function change including the swallowing and gastric regurgitation between intubated and nonintubated thoracoscopy still remains unclear.\n\nThe esophageal manometry has pressure sensor to measure the upper esophageal sphincter (UES) pressure. The manometry and impedance could detect the esophageal swallowing function during the perioperative period. The ultrasonography was used to measure the oropharyngeal swallowing function.\n\nObjectives:the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography.\n\nPatients and methods: Consecutive patients who will fulfill the criteria of nonintubated patients under general anesthesia and age from 20 to 80 years old will be enrolled. All subjects would receive the swallowing function by ultrasonography before the surgeries. The cough test and gastric volume were also measured. The patient was randomized by the intubated or nonintubated thoracoscopy. After induction, the endotracheal tube (ETT) will be inserted to establish airway. The non-intubated group will be use the oxygen mask and the nasal airway to maintain the airway patent. After the patients were sedated, investigators would use the video-assisted laryngoscope to let the manometry and impedance transnasal into the esophagus.These esophageal function was measured during the whole perioperative periods, especially the recovery from anesthesia in the postoperative anesthesia unit (PACU). The patients will be followed for the swallowing function by ultrasonography and cough test in the PACU, too. The oxidative test would be performed by blood test on the time, which were after anesthesia, one-lung ventilation 15 to 30 minutes, and two-lung ventilation 15 to 20 minutes, respectively.\n\nExpected result: investigators will observe the changes between the patients receiving intubated or nonintubated thoracoscopies of the changes between the preoperative and postoperative changes in the swallowing function, cough and gastric regurgitation. The oxidative test will also be tested accompanied by the anesthetic monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who fulfill the criteria of nonintubated thoracoscopy under general anesthesia, including tumours smaller than 6 cm, peripheral lesions, no evidence of severe adhesion; and no evidence of chest wall, diaphragm, or main bronchus involvement. Patients who had potential or confirmed airway complications such as bronchial tumor or hemothorax, morbid obesity (BMI greater than 35 kg·m-2), coagulopathy, anatomical deformity or an American Society of Anesthesiology (ASA) classification greater than 3 were excluded\n2. Aged from 20-80 years old\n\nExclusion Criteria:\n\n1. Major systemic disease, such as congestive heart failure, liver cirrhosis, and end stage renal disease.\n2. Patients who have the risk of difficult ventilation or intubation.\n3. pregnant women\n4. coagulopathy'}, 'identificationModule': {'nctId': 'NCT03711461', 'briefTitle': 'Recovery Between NIVATS and Intubated Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparisons of the Risks of Gastric Distension and Delayed Recovery of Cough Reflex and Oral Intake on Intubated and Non-intubated VATS Patients', 'orgStudyIdInfo': {'id': '201804093RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nonintubated', 'description': 'patients received nonintubated during thoracoscopy', 'interventionNames': ['Device: nonintubated']}, {'type': 'EXPERIMENTAL', 'label': 'intubated', 'description': 'patients receiving intubated during thoracoscopy', 'interventionNames': ['Device: endotracheal tube (double lumen)']}], 'interventions': [{'name': 'endotracheal tube (double lumen)', 'type': 'DEVICE', 'description': 'patients routinely use double lumen endotracheal intubation while they have received thoracoscopy', 'armGroupLabels': ['intubated']}, {'name': 'nonintubated', 'type': 'DEVICE', 'description': 'patients receiving nonintubated anesthetic plan while they have received thoracoscopy', 'armGroupLabels': ['nonintubated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ya-Jung Cheng, MD', 'role': 'CONTACT', 'email': 'chengyj@ntu.edu.tw', 'phone': '0223123456'}], 'facility': 'Ya-Jung Cheng', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ya-Jung Cheng, MD', 'role': 'CONTACT', 'email': 'chengyj@ntu.edu.tw', 'phone': '+886-972651609'}], 'overallOfficials': [{'name': 'Ya-Jung Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}