Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05502120
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2022-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007828', 'term': 'Laryngoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-08-12', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in laryngeal view', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope'}], 'secondaryOutcomes': [{'measure': 'intubation efficiency', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Success of intubation using Vie-Scope laryngoscope'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['morbid obesity', 'endotracheal intubation'], 'conditions': ['Obesity, Morbid', 'Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Macintosh laryngoscope is still considered a standard for tracheal intubation, however, visualization of the glottis may be inadequate mainly in morbidly obese patients. The Vie Scope is a novel type of laryngoscope consisting of a straight, shielded, illuminated tube that offers intubation via a bougie using the paraglossal technique. In this prospective, non-randomized study, we tested the research hypothesis that the use of Vie Scope may improve visualization of the larynx in comparison with the Macintosh blade.', 'detailedDescription': 'Prior to tracheal intubation, all patients were placed in the head-elevated laryngoscopy position (HELP). All study subjects were anesthetized with the concordance to European Society for Peri-Operative Care of Obese Patient (www.espcop.eu) protocols: proper positioning, pre-oxygenation with CPAP, induction of anesthesia with propofol 2.0 mg kg-1 of corrected body weight; for muscle relaxation rocuronium 0.6 mg kg-1 of ideal body weight (IBW); ketamine 50 mg ; lidocaine 100 mg, and fentanyl 0.1 mg. After achieving 100% neuromuscular block confirmed by TOF-Watch monitoring, laryngoscopy was performed by the anesthesiologist familiar with the use of both Vie Scope and Macintosh blade laryngoscope, and also experienced in bariatric anesthesia. All anesthesiologists participating in the study underwent training with Vie Scope on the manikin model.\n\nThe evaluation of glottis visualization in direct laryngoscopy using Cormack-Lehane scale (CL) in all patients was performed in sequence using two laryngoscopes: first Macintosh blade laryngoscope (MCL) and then Vie Scope laryngoscope (VS). Tracheal intubation was performed with the VS. The study subjects all received oxygen using nasal CPAP in order to maintain sufficient oxygenation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* morbid obesity BMI\\>40 kg/m2\n* scheduled for elective bariatric procedure\n* no anatomy abnormalities of upper airway\n\nExclusion Criteria:\n\n* lack of conscent\n* predicted difficult intubation'}, 'identificationModule': {'nctId': 'NCT05502120', 'briefTitle': 'A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'A Comparison of Visualization of the Larynx With the Vie Scope Versus Standard Macintosh Laryngoscope in Morbidly Obese Patients.', 'orgStudyIdInfo': {'id': 'RNN/49/21/KB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh blade', 'description': 'Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope', 'interventionNames': ['Device: Laryngoscopy with Macintosh blade laryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Vie-Scope', 'description': 'Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope', 'interventionNames': ['Device: Laryngoscopy with Vie-Scope laryngoscope']}], 'interventions': [{'name': 'Laryngoscopy with Vie-Scope laryngoscope', 'type': 'DEVICE', 'description': 'Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications', 'armGroupLabels': ['Vie-Scope']}, {'name': 'Laryngoscopy with Macintosh blade laryngoscope', 'type': 'DEVICE', 'description': 'Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope', 'armGroupLabels': ['Macintosh blade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Medical University of Lodz, Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}