Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT03392818
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2017-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Innovative Approach for Uniblocker Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2018-12-28', 'unreleaseDate': '2018-12-30'}, {'resetDate': '2023-11-22', 'releaseDate': '2023-02-14'}], 'estimatedResultsFirstSubmitDate': '2018-12-28'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D005526', 'term': 'Food, Formulated'}], 'ancestors': [{'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-06', 'studyFirstSubmitDate': '2017-12-24', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intubation time', 'timeFrame': '1 year', 'description': 'The intubation time defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until Uniblocker at the optimal position and this was done using a stopwatch.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Therapeutic Procedural Complication']}, 'descriptionModule': {'briefSummary': 'To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.', 'detailedDescription': 'In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients undergoing left side thoracic surgery\n2. The thoracic surgery requiring a Uniblocker for one-lung ventilation\n\nExclusion Criteria:\n\n1. Age\\>70 or \\<18 years\n2. ASA classifications \\>III\n3. BMI \\>35kg/m2\n4. Modified Mallampati classification ≥III\n5. Thoracic surgery within the last one month\n6. Severe cardiopulmonary disease'}, 'identificationModule': {'nctId': 'NCT03392818', 'briefTitle': 'An Innovative Approach for Uniblocker Intubation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'An Innovative Approach for Accurately Predicting the Optimal Insertion Depth of Uniblocker Without Fiberoptic Bronchoscope Assistance', 'orgStudyIdInfo': {'id': '966169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'formula', 'description': "Calculate the depth of intubation according to the formula of 0.1977\\* patient's height - 4.2423", 'interventionNames': ['Other: formula']}, {'type': 'EXPERIMENTAL', 'label': 'Fiberoptic bronchoscope', 'description': 'intubation of Uniblocker under the Under the guidance of Fiberoptic bronchoscope', 'interventionNames': ['Device: Fiberoptic bronchoscope']}, {'type': 'EXPERIMENTAL', 'label': 'The measured distance', 'description': 'To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.', 'interventionNames': ['Other: The measured distance']}], 'interventions': [{'name': 'The measured distance', 'type': 'OTHER', 'description': 'To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of Fiberoptic bronchoscope.', 'armGroupLabels': ['The measured distance']}, {'name': 'formula', 'type': 'OTHER', 'description': "Calculate the depth of intubation according to the formula of 0.1977\\* patient's height - 4.2423", 'armGroupLabels': ['formula']}, {'name': 'Fiberoptic bronchoscope', 'type': 'DEVICE', 'description': 'The intubation of Uniblocker under the guidance of Fiberoptic bronchoscope', 'armGroupLabels': ['Fiberoptic bronchoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuo Liu', 'role': 'CONTACT', 'email': 'liuzhuo2011@yeah.net', 'phone': '+86-03355908581'}], 'facility': 'The first hospital of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'centralContacts': [{'name': 'Yang Li', 'role': 'CONTACT', 'phone': '+86-03355908500'}, {'name': 'Ximing Qi', 'role': 'CONTACT', 'email': 'ximingqi123@sina.com', 'phone': '+8631187027951'}], 'overallOfficials': [{'name': 'Ximing Qi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Qinhuangdao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-12-28', 'type': 'RELEASE'}, {'date': '2018-12-30', 'type': 'UNRELEASE'}, {'date': '2023-02-14', 'type': 'RELEASE'}, {'date': '2023-11-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The First Hospital of Qinhuangdao'}}}}