Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-03 @ 9:38 PM
Study NCT ID:
NCT02669550
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2015-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-23', 'studyFirstSubmitDate': '2015-11-22', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of throat pain measured by VAS', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fiberoptic bronchoscope', 'Disposcope endoscope', 'Awake orotracheal intubation'], 'conditions': ['Therapeutic Procedural Complication']}, 'descriptionModule': {'briefSummary': 'The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the management of difficult tracheal intubation, and it is considered as a gold standard. The disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical practice recently.This study compares FOB and DE for awake orotracheal intubation in obese patients with anticipated difficult airway.', 'detailedDescription': 'Forty obese patients with anticipated difficult airways were randomised to undergo awake orotracheal intubation by FOB(group F) or DE(group D) after conscious sedation. The conditions of orotracheal intubation, the time needed to view the vocal cords and to complete the orotracheal intubation, the hemodynamic changes and the adverse events including bradycardia, respiratory depression during orotracheal intubation, throat pain, hoarseness and memory after surgery were recorded. The ease of view the vocal cords and passing the tracheal tube through the glottis were also evaluated by using a visual analogue scale (VAS) by operator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.\n\nExclusion Criteria:\n\n* Exclusion criteria included age younger than 18 yr,\n* ASA class IV or V,\n* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions'}, 'identificationModule': {'nctId': 'NCT02669550', 'briefTitle': 'Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'A Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope During Awake Orotracheal Intubation in Obese Patients With Anticipated Difficult Airway : A Prospective, Randomised and Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiberoptic bronchoscope', 'description': 'In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB', 'interventionNames': ['Device: Fiberoptic bronchoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Disposcope endoscope', 'description': 'In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity', 'interventionNames': ['Device: Disposcope endoscope']}], 'interventions': [{'name': 'Fiberoptic bronchoscope', 'type': 'DEVICE', 'description': 'In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB', 'armGroupLabels': ['Fiberoptic bronchoscope']}, {'name': 'Disposcope endoscope', 'type': 'DEVICE', 'description': 'In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity', 'armGroupLabels': ['Disposcope endoscope']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ximing Qi, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Qinhuangdao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}