Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-26 @ 12:22 AM
Study NCT ID:
NCT06505850
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative sore throat', 'timeFrame': 'Postoperative 48 hours'}, {'measure': 'The severity of postoperative sore throat', 'timeFrame': 'Postoperative 48 hours', 'description': '1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain)'}], 'secondaryOutcomes': [{'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'The end of surgery'}, {'measure': 'Intraoperative propofol consumption', 'timeFrame': 'The end of surgery'}, {'measure': 'Intraoperative rocuronium consumption', 'timeFrame': 'The end of surgery'}, {'measure': 'The degree of subglottic injury', 'timeFrame': 'Intraoperative (The time point at extubation)', 'description': 'None: no subglottic injury; mild: mucosal hyperemia and edema and/or slight submucosal hematoma; moderate: moderate submucosal hematoma; severe: mucosal laceration and/or mucosal bleeding)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Endotracheal tube cuff', 'Postoperative sore throat', 'Subglottic airway injury', 'Breast Cancer'], 'conditions': ['Breast Cancer', 'Postoperative Sore Throat', 'Subglottic Airway Injury', 'Endotracheal Tube Cuff']}, 'referencesModule': {'references': [{'pmid': '2331067', 'type': 'BACKGROUND', 'citation': 'Monroe MC, Gravenstein N, Saga-Rumley S. Postoperative sore throat: effect of oropharyngeal airway in orotracheally intubated patients. Anesth Analg. 1990 May;70(5):512-6. doi: 10.1213/00000539-199005000-00008.'}, {'pmid': '7880666', 'type': 'BACKGROUND', 'citation': 'Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.'}, {'pmid': '15892411', 'type': 'BACKGROUND', 'citation': 'Biro P, Seifert B, Pasch T. Complaints of sore throat after tracheal intubation: a prospective evaluation. Eur J Anaesthesiol. 2005 Apr;22(4):307-11. doi: 10.1017/s0265021505000529.'}, {'pmid': '20206846', 'type': 'BACKGROUND', 'citation': 'Lehmann M, Monte K, Barach P, Kindler CH. Postoperative patient complaints: a prospective interview study of 12,276 patients. J Clin Anesth. 2010 Feb;22(1):13-21. doi: 10.1016/j.jclinane.2009.02.015.'}, {'pmid': '27158989', 'type': 'BACKGROUND', 'citation': 'El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.'}, {'pmid': '28368938', 'type': 'BACKGROUND', 'citation': 'Chang JE, Kim H, Han SH, Lee JM, Ji S, Hwang JY. Effect of Endotracheal Tube Cuff Shape on Postoperative Sore Throat After Endotracheal Intubation. Anesth Analg. 2017 Oct;125(4):1240-1245. doi: 10.1213/ANE.0000000000001933.'}, {'pmid': '40221641', 'type': 'DERIVED', 'citation': 'Chen GC, Lo KL, Wu ZF, Chan SM, Cheng SY, Ko CL, Chu CM, Tseng WC. Comparison of the incidence and severity of postoperative sore throat and subglottic airway injury with cylindrical versus tapered cuff endotracheal tubes in women undergoing surgery for breast cancer: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 12;25(1):181. doi: 10.1186/s12871-025-03040-y.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat', 'detailedDescription': 'Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation\n\nExclusion Criteria:\n\n* Age \\< 18 years or age \\> 80 years\n* Diseases or anatomic abnormalities in the neck, larynx, or pharynx\n* Combined surgery such as breast reconstruction\n* Active pulmonary disease\n* Morbid obesity (body mass index ≥ 40 kg/m2)\n* Pregnancy\n* Refusal to join the study'}, 'identificationModule': {'nctId': 'NCT06505850', 'briefTitle': 'Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Comparisons of Postoperative Sore Throat and Subglottic Airway Injury Between Endotracheal Tubes with Different Cuff Shapes in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'A202405086_V3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tapered-shaped cuff ETT group', 'description': 'A tapered-shaped cuff tube was used to intubate for general anesthesia', 'interventionNames': ['Device: Tapered-shaped cuff tracheal tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cylindrical-shaped cuff ETT group', 'description': 'A cylindrical-shaped cuff tube was used to intubate for general anesthesia', 'interventionNames': ['Device: Cylindrical-shaped cuff tracheal tube']}], 'interventions': [{'name': 'Tapered-shaped cuff tracheal tube', 'type': 'DEVICE', 'description': 'Tracheal intubation with a tapered-shaped cuff tube', 'armGroupLabels': ['Tapered-shaped cuff ETT group']}, {'name': 'Cylindrical-shaped cuff tracheal tube', 'type': 'DEVICE', 'description': 'Tracheal intubation with a cylindrical-shaped cuff tube', 'armGroupLabels': ['Cylindrical-shaped cuff ETT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wei-Cheng Tseng', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}