Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05243758
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2021-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Who is Rapid And Success? The Comparison Of Video Fiberscope And Video Laryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '60 patients aged between 18-65 years, who were operated in the operating room of our hospital, with an EGRI score of \\>4 and an ASA (American Society of Anesthesiologists) score of \\<4 were included.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation times,', 'timeFrame': 'during intubation', 'description': 'The moment when the endotracheal intubation tube was passed between the vocal cords following the vocal cord image obtained with the device was recorded in seconds. In endotracheal intubation performed with a video fiberscope, the end of the fiberscope with a camera passing through the vocal cords, and in endotracheal intubation performed with a DCI video laryngoscope, the intubation tube passing between the vocal cords was counted as successful intubation time.'}, {'measure': 'Number of attempts', 'timeFrame': 'during intubation for patients,', 'description': 'The procedure will be considered unsuccessful if intubation is unsuccessful in three attempts, if the intubation process exceeds three minutes, or if the peripheral oxygen saturation (SpO2) is \\<90% during this period. If this situation was encountered, it was planned to ventilate the patient with an anesthesia mask until the oxygen saturation approached 100% and to use alternative airway devices.'}, {'measure': 'Time to find the glottis:', 'timeFrame': 'during intubation for patients', 'description': "The time from the moment the device entered between the patient's anterior incisors until the vocal cords were seen was recorded in seconds."}, {'measure': 'Blood pressure', 'timeFrame': 'During intubation, at 1st, 2nd and 5th minutes after intubation', 'description': 'Hemodynamic parameters; heart rate (/min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), and SpO2 were recorded before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation'}, {'measure': 'Pulse oximeter', 'timeFrame': 'Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation', 'description': "Oximetry is a convenient and painless alternative to needlesticks, is simple to use, and provides immediate data. These advantages make oximetry an invaluable tool for determination the client's need for oxygen therapy and assessing effectiveness of therapy. The oximeter registers arterial oxygen saturation (SaO2). An SaO2 greater than 95% is considered normal, whereas values lower than 93% usually indicate the need for oxygen therapy and further assessment."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation; Difficult or Failed', 'Airway Responsiveness']}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation plays an important role in general anesthesia. Complications can be prevented by using alternative airway devices in predetermined difficult intubation cases. In this study, the investigators aimed to compare the results of endotracheal intubation with video fiberscope and DCI video laryngoscope devices of two different experienced physicians (E and H).', 'detailedDescription': 'In this randomized and prospective study, 60 patients with EGRI score\\> 4 and ASA score \\<4, operated between 1 October 2018 and 1 March 2019 in Ondokuz Mayıs University Medical Faculty Hospital were included. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operated in the operating room of our hospital,\n* Aged 18-65,\n* EGRI score\\>4,\n* ASA (American Society of Anesthesiologists) score\\<4\n\nExclusion Criteria:\n\n* Cerebrovascular disease (cerebral ischemia, hemorrhage or stroke), presence of carotid stenosis or history of coronary artery disease,\n\n * Neurological disorders (history of chronic headache, epilepsy or head trauma), alcohol or psychoactive drug addiction,\n * Serious heart and/or lung diseases, liver and/or kidney failure,\n * Uncontrolled diabetes and/or hypertension,\n * Dental abscess,\n * Mouth opening \\<1.5 cm,\n * Known bleeding disorder,\n * Pregnancy,\n * Mental retardation,\n * Contraindications to drugs, allergy to drugs used,\n * Patient rejection'}, 'identificationModule': {'nctId': 'NCT05243758', 'briefTitle': 'Who is Rapid And Success? The Comparison Of Video Fiberscope And Video Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'The Comparison Of Video Fiberscope And Video Laryngoscope,With Egri Score> 4', 'orgStudyIdInfo': {'id': 'B.30.2.ODM.0.20.08/1822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group video fiberscope of experienced practitioner', 'description': 'More experienced physician: endotracheal intubation with video fiberscope Assoc. Dr. The group in which Ersin Köksal performed endotracheal intubation using a video fiberscope( Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.', 'interventionNames': ['Device: Group video fiberscope of experienced practitioner', 'Device: Group video fiberscope of less experienced practitioner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group video laryngoscope of experienced practitioner', 'description': 'More experienced physician: Endotracheal intubation with DCI video laryngoscopeThe group in which Assoc. Dr. Ersin Köksal performed endotracheal intubation using a DCI video laryngoscope(Storz DCI Video Laryngoscope (Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.', 'interventionNames': ['Device: Group video laryngoscope of experienced practitioner', 'Device: Group video laryngoscope of less experienced practitioner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group video fiberscope of less experienced practitioner', 'description': 'Endotracheal intubation with video fiberscope: The group in which DrHalil Cebeci applied endotracheal intubation using a video fiberscope( Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany) consisted of 15 patients. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.', 'interventionNames': ['Device: Group video fiberscope of experienced practitioner', 'Device: Group video fiberscope of less experienced practitioner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group video laryngoscope of less experienced practitioner', 'description': 'Endotracheal intubation with DCI video laryngoscope:The group in which Dr.Halil Cebeci applied endotracheal intubation using a DCI video laryngoscope(Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.', 'interventionNames': ['Device: Group video laryngoscope of experienced practitioner', 'Device: Group video laryngoscope of less experienced practitioner']}], 'interventions': [{'name': 'Group video fiberscope of experienced practitioner', 'type': 'DEVICE', 'description': 'One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopyvideo fiberscope( Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.', 'armGroupLabels': ['Group video fiberscope of experienced practitioner', 'Group video fiberscope of less experienced practitioner']}, {'name': 'Group video laryngoscope of experienced practitioner', 'type': 'DEVICE', 'description': 'Intubation Pending Difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.', 'armGroupLabels': ['Group video laryngoscope of experienced practitioner', 'Group video laryngoscope of less experienced practitioner']}, {'name': 'Group video fiberscope of less experienced practitioner', 'type': 'DEVICE', 'description': 'One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopy video fiberscope( Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.', 'armGroupLabels': ['Group video fiberscope of experienced practitioner', 'Group video fiberscope of less experienced practitioner']}, {'name': 'Group video laryngoscope of less experienced practitioner', 'type': 'DEVICE', 'description': 'Entubation pending difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.Storz DCI Video Laryngoscope (Karl Storz GmbH \\&Co. KG, Tuttlingen, Germany)', 'armGroupLabels': ['Group video laryngoscope of experienced practitioner', 'Group video laryngoscope of less experienced practitioner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200', 'city': 'Samsun', 'state': 'Atakum', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University Faculty of Medicine', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'ERSIN KOKSAL, PROFFOSOR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident ,Principal Investigator', 'investigatorFullName': 'Halil CEBECI', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}