Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT04591769
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2020-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tracheal Tube Cuff Shape and Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient will be intubated by an anesthesiologist who is aware of the grouping. After tracheal intubation is finished, the cuff is connected to the pressure monitor system and another blinded assessor will adjust and record the minimal volume that is required for sealing the tracheal tube-ventilator. The cuff pressure will be monitored and recorded all throughout the surgical period. A blinded assessor will follow up the patient after the surgery and do the voice analysis. Patients are unaware of the type of tracheal tube they used and will score subjectively for the sore throat and postoperative dysphonia.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-11', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2020-10-10', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Just seal tracheal tube cuff pressure', 'timeFrame': '1 minute after anesthesia and tracheal intubation', 'description': 'Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system'}, {'measure': 'Tracheal tube cuff pressure on retractor splay', 'timeFrame': 'Intraoperative monitoring', 'description': 'Cuff pressure when the retractors are set-up and removed'}], 'secondaryOutcomes': [{'measure': 'Sore throat-NRS', 'timeFrame': 'preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7', 'description': 'Postoperative sore throat, Numeric Rating Scale(NRS) 0\\~10; 0=no sore throat; 10=maximal sore throat'}, {'measure': 'Sore throat-VAS', 'timeFrame': 'preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7', 'description': 'Postoperative sore throat, Visual Analogue Scale (VAS) 0\\~10; 0=no sore throat; 10=maximal sore throat'}, {'measure': 'Subjective dysphonia', 'timeFrame': 'preOP day 1, post OP 2 hours, day 1, 2, 3, 7', 'description': 'Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline'}, {'measure': 'Subjective dysphonia-GRBAS score', 'timeFrame': 'One day before operation, and post operation day 1', 'description': 'GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline'}, {'measure': 'Subjective dysphonia- Voice Handicap Index-10(VHI-10)', 'timeFrame': 'One day before operation, and post operation day 7', 'description': 'VHI-10 questionnaire (0 best\\~40 worst; \\>15 may be abnormal)'}, {'measure': 'Objective dysphonia', 'timeFrame': 'One day before operation(baseline), and post operation day 1', 'description': 'Software voice analysis; compared with baseline'}, {'measure': 'Postoperative complication', 'timeFrame': 'After operation to post operation day 7', 'description': 'Any postoperative complication related complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation, Intratracheal', 'Pain, Postoperative', 'Dysphonia']}, 'referencesModule': {'references': [{'pmid': '35847807', 'type': 'DERIVED', 'citation': 'Li YS, Tan EC, Tsai YJ, Mandell MS, Huang SS, Chiang TY, Huang WC, Chang WK, Chu YC. A Tapered Cuff Tracheal Tube Decreases the Need for Cuff Pressure Adjustment After Surgical Retraction During Anterior Cervical Spine Surgery: A Randomized Controlled, Double-Blind Trial. Front Med (Lausanne). 2022 Jun 29;9:920726. doi: 10.3389/fmed.2022.920726. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.', 'detailedDescription': 'High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving elective anterior cervical spine surgery\n* Right side approach\n\nExclusion Criteria:\n\n* Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies)\n* Anticipated difficult airway\n* Facial anomaly that may hinder facemask ventilation\n* Preoperative hoarseness or vocal cord palsy regardless of etiology\n* Re-operation of cervical spine surgery or left side approach\n* BMI \\>35\n* Operation field involved cervical spine C1 or C2\n* Unwilling to sign the informed consent\n* Unwilling to finish the study'}, 'identificationModule': {'nctId': 'NCT04591769', 'briefTitle': 'Tracheal Tube Cuff Shape and Pressure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Cuff Pressure During Surgical Retractor Splay and Postoperative Voice Outcome After Anterior Cervical Spine Surgery: Comparison Between Tapered-shaped and Conventional Cylindrical-shaped Endotracheal Tube', 'orgStudyIdInfo': {'id': '2020-10-002C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group T(Tapered- shaped)', 'description': 'Tracheal intubation using TaperedGuard Tracheal Tube', 'interventionNames': ['Device: Different tracheal tube cuff design']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C(Cylindrical-shaped)', 'description': 'Tracheal intubation using Hi-Contour Tracheal Tube', 'interventionNames': ['Device: Different tracheal tube cuff design']}], 'interventions': [{'name': 'Different tracheal tube cuff design', 'type': 'DEVICE', 'description': 'Comparison of effect between 2 different designs of tracheal tube cuff', 'armGroupLabels': ['Group C(Cylindrical-shaped)', 'Group T(Tapered- shaped)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ya-Chun Chu, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to yachunchu@gmail.com. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ya-Chun Chu, MD, PhD, Division of Neuroanesthesia, Department of Anesthesiology', 'investigatorFullName': 'vghtpe user', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}