Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-27 @ 7:10 AM
Study NCT ID:
NCT05647395
Status:
UNKNOWN
Last Update Posted:
2022-12-12
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grading of cough reaction', 'timeFrame': 'During extubation procedure', 'description': 'Grading of cough reactions'}, {'measure': 'Change in Blood pressure', 'timeFrame': 'Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation', 'description': 'Hemodynamics'}, {'measure': 'Change in Heart rate', 'timeFrame': 'Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation', 'description': 'Hemodynamics'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': 'Within 24 hours after removal of the endotracheal tube', 'description': 'Hypoventilation, pharyngeal discomfort, hoarseness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deflating method', 'Extubation phase', 'Coughing reaction'], 'conditions': ['Deflating Method']}, 'descriptionModule': {'briefSummary': 'Patients with endotracheal intubation and general anesthesia often have severe choking and hemodynamic fluctuations during the extubation period, which increases the risk of cerebrovascular accident, arrhythmia, incision bleeding and so on . This study aimed to observe the effects of different methods of deflating of endotracheal tube cuffs on cough response and hemodynamics during periextubation in patients undergoing general anesthesia surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective endotracheal intubation under general anesthesia.\n2. Operation time \\< 3 h.\n3. ASA grade I or II.\n4. Age 18\\~65 years old.\n\nExclusion Criteria:\n\n1. Throat and neck surgery.\n2. Those assessed to have a high risk of reflux aspiration.\n3. Difficulty intubation.\n4. History of snoring before surgery.\n5. Recent respiratory illness such as chronic cough.\n6. Previous airway hyperresponsiveness, such as asthma.\n7. recent use of cough suppressants.\n8. Patients with severe heart, liver and kidney diseases.'}, 'identificationModule': {'nctId': 'NCT05647395', 'briefTitle': 'Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Yangzhou University'}, 'officialTitle': 'Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation', 'orgStudyIdInfo': {'id': '20221121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slowly and evenly draw the gas in the cuff', 'interventionNames': ['Behavioral: Tracheal tube cuffs differ in deflation']}, {'type': 'NO_INTERVENTION', 'label': 'One-time aspiration of tracheal catheter cuff gas'}], 'interventions': [{'name': 'Tracheal tube cuffs differ in deflation', 'type': 'BEHAVIORAL', 'description': 'When removing the endotracheal tube, the gas in the cuff is drawn at a uniform and slow pace', 'armGroupLabels': ['Slowly and evenly draw the gas in the cuff']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuan Zhang, professor', 'role': 'CONTACT', 'email': 'zhangzhuancg@163.com', 'phone': '+8615062791355', 'phoneExt': '+8615062791355'}], 'facility': 'the Affiliated Hospital of Yangzhou University, Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Zhuan Zhang', 'role': 'CONTACT', 'email': 'zhangzhuancg@163.com', 'phone': '+8615062791355'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhuan Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhuan Zhang', 'investigatorAffiliation': 'Yangzhou University'}}}}