Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-06 @ 2:03 PM
Study NCT ID:
NCT04174833
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2019-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008865', 'term': 'Microstomia'}], 'ancestors': [{'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2019-10-06', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful videolaryngoscopic endotracheal intubation rate', 'timeFrame': 'Within 1 hour after anesthesia induction', 'description': 'Observation during airway management'}], 'secondaryOutcomes': [{'measure': 'First pass success rate', 'timeFrame': 'Within 1 hour after anesthesia induction', 'description': 'Observation during airway management'}, {'measure': 'Endotracheal intubation difficulty', 'timeFrame': 'Within 1 hour after concluded endotracheal intubation', 'description': 'Subjective rating on a numeric rating scale \\[0-100\\]; 0 - very easy; 100 - very difficult'}, {'measure': 'Best view obtained', 'timeFrame': 'Within 1 hour after concluded endotracheal intubation', 'description': 'Cormack-Lehane classification'}, {'measure': 'Intubation time', 'timeFrame': 'Within 1 hour after anesthesia induction', 'description': 'Observation during airway management'}, {'measure': 'Number of attempts', 'timeFrame': 'Within 1 hour after anesthesia induction', 'description': 'Observation during airway management'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GlideScope', 'Airway Management', 'Videolaryngoscopic Intubation'], 'conditions': ['Intubation;Difficult', 'Videolaryngoscopy', 'Small Mouth']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical performance, quality of larynx visualization and difficulty of videolaryngoscopic intubation in patients with a reduced mouth opening (1.0 to 3.0 cm) utilizing the latest generation of GlideScopeTM Spectrum low profile laryngoscopy system.', 'detailedDescription': 'Reduced mouth opening in adults has been proven an important risk factor for difficult endotracheal intubation utilizing both direct and indirect laryngoscopy techniques, and a major reason for anesthesia-related adverse events. Over the past two decades, videolaryngoscopy has evolved to be the primary indirect laryngoscopy technique in a difficult endotracheal intubation setting. The possibility for optimal visualization of the laryngeal structures renders this method particularly helpful in patients with limited mouth opening. Especially videolaryngoscopy with acute-angle blades has been proposed to be favorable over conventional direct laryngoscopy in this setting. However, previous research has shown that a mouth opening of approximately 2.0 - 3.0 cm represents an independent risk factor and a possible critical lower limit for safe videolaryngoscopic intubation.\n\nThe latest generation of GlideScopeTM Spectrum blades may provide sufficient intubation conditions even in patients with a maximum mouth opening below 3.0 cm.\n\nOur research group aims to evaluate the clinical performance, quality of larynx visualization and severity of videolaryngoscopic intubation the GlideScopeTM Spectrum system in patients with a small mouth opening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for non-cardiac surgery under general anesthesia with a need for endotracheal intubation presenting at the Anesthesiology Preassessment Clinic of the Hamburg University Hospital with a mouth opening between 1.0 and 3.0 cm within the recruiting period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for non-cardiac surgery\n* Required general anesthesia and endotracheal intubation\n* Mouth opening between 1.0 and 3.0 cm (any reason) recognized during preoperative assessment\n* Written consent provided\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Confirmed indication for awake fiberoptic intubation, especially due to enoral and pharyngeal tumors, abscesses or other obstructive lesions\n* Endotracheal intubation planned without deep general anesthesia or without neuromuscular blockade (e.g. awake videolaryngoscopy)\n* Qualification for rapid sequence anesthesia induction due to risk of pulmonary aspiration\n* Loose teeth'}, 'identificationModule': {'nctId': 'NCT04174833', 'briefTitle': 'GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening, a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'PV6094'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Verathon', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}