Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-21 @ 5:01 AM
Study NCT ID:
NCT03854760
Status:
UNKNOWN
Last Update Posted:
2019-03-06
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Training and Evaluate Effect on Clinical Airway Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072080', 'term': 'Anesthesiologists'}], 'ancestors': [{'id': 'D000072077', 'term': 'Anesthetists'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D010820', 'term': 'Physicians'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Efforts needed on simulate.', 'timeFrame': 'An average of 6 hours, since begin of simulate training.', 'description': 'Hours needed to achieve well-trained.'}, {'measure': 'Efforts needed on simulate.', 'timeFrame': 'An average of 6 hours, since begin of simulate training.', 'description': 'Cases needed to achieve well-trained.'}], 'primaryOutcomes': [{'measure': 'Change of Time needed.', 'timeFrame': 'Changes from baseline after finishing simulate training, an average of 1 month.', 'description': 'Change of time needed to navigate using bronchoscopy.'}, {'measure': 'Change of modified global rating scores (GRS).', 'timeFrame': 'Changes from baseline after finishing simulate training, an average of 1 month.', 'description': 'Change of modified global rating scores (GRS) rating manufacturing skills using bronchoscopy. Total score ranges from 4 to 20 scores at 1-score intervals, higher score matches better skill. Total score is the submission of four subscales, which evaluating central view, mucosal contact, progress and orientation using bronchoscopy, ranges from 1 to 5 scores at 1-score interval, higher scores represent better outcome.'}, {'measure': 'Change of Likert score.', 'timeFrame': 'Changes from baseline after finishing simulate training, an average of 1 month.', 'description': 'Change of Likert score evaluating self-confidence using bronchoscopy. Likert score ranges from 1 to 5 scores at 1-score intervals, higher score with more self-confidence.'}], 'secondaryOutcomes': [{'measure': 'Inconsistency of evaluation of time needed between simulate and clinical practice.', 'timeFrame': 'At the beginning and after finishing the training, an average of 1 month.', 'description': 'Inconsistency of time needed to navigate using bronchoscopy.'}, {'measure': 'Inconsistency of evaluation of modified global rating scores (GRS) between simulate and clinical practice.', 'timeFrame': 'At the beginning and after finishing the training, an average of 1 month.', 'description': 'Inconsistency of modified global rating scores (GRS) rating manufacturing skills, using bronchoscopy. Total score ranges from 4 to 20 scores at 1-score intervals, higher score matches better skill. Total score is the submission of four subscales, which evaluating central view, mucosal contact, progress and orientation using bronchoscopy, ranges from 1 to 5 scores at 1-score interval, higher scores represent better outcome.'}, {'measure': 'Inconsistency of evaluation of Likert score between simulate and clinical practice.', 'timeFrame': 'At the beginning and after finishing the training, an average of 1 month.', 'description': 'Inconsistency of Likert score evaluating self-confidence using bronchoscopy. Likert score ranges from 1 to 5 scores at 1-score intervals, higher score with more self-confidence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Management', 'Education', 'Bronchoscopy']}, 'descriptionModule': {'briefSummary': 'In this self-control experiment, anesthesiologists with limited experiments of bronchoscopy working in anesthesiology department in Peking Union Medical College Hospital will receive a training and evaluation procedure in simulation and clinical practice about clinical airway management. The objects was (1) to investigate the improvements of manufacturing bronchoscopy in simulation and clinical practise before and after training on simulation,(2) to record the efforts trainees needed to achieve experienced on simulation, (3) to evaluate if status manufacturing on simulations could reflect the ones in clinical practise.', 'detailedDescription': 'A modified global rating scale from 1 (unskilled) to 5 (expert) with a score of 3 linked to proficiency, and 5-points Likert from 1 (felt extremely unsure) to 5 (felt extremely confidence) with a score of 4 linked to confidence were used to evaluate during the procedure of training and evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An anesthesiologist who is working on anesthesia airway management；\n2. During the research period, he/she worked in the anesthesiology department of Peking Union Medical College Hospital；\n3. Have some experience in airway management，Meet at least one of the following conditions: ①Airway management experience ≤10 cases；②Objective GRS score \\<3 points；③Subjective Likert score \\<3 points\n\nExclusion Criteria:\n\n1. Cannot complete pre-training assessment；\n2. Cannot complete the training course；\n3. Cannot complete the post-training evaluation；\n4. Clinical airway managers were not performed during the study period.'}, 'identificationModule': {'nctId': 'NCT03854760', 'briefTitle': 'The Training and Evaluate Effect on Clinical Airway Management', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Training and Evaluate Effect of Simulation on Clinical Airway Management During Perioperative Period', 'orgStudyIdInfo': {'id': 'zs1809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anesthesiologist with limited experiment', 'description': 'Anesthesiologists with limited experiment of bronchoscopy.', 'interventionNames': ['Behavioral: anesthesiologist with limited experiment']}], 'interventions': [{'name': 'anesthesiologist with limited experiment', 'type': 'BEHAVIORAL', 'description': 'Using the simulate device, the trainees are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice.', 'armGroupLabels': ['anesthesiologist with limited experiment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chunhua Yu, Doctor', 'role': 'CONTACT', 'email': 'counsissis@sina.com', 'phone': '010-69152030'}, {'name': 'Yuan Tian, Doctor', 'role': 'CONTACT', 'email': 'counsissis@sina.com', 'phone': '18810261573'}], 'overallOfficials': [{'name': 'Chunhua Yu, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Chunhua Yu', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}