Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-16 @ 2:09 PM
Study NCT ID:
NCT03879720
Status:
UNKNOWN
Last Update Posted:
2019-11-08
First Post:
2019-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Standard and Endoscope Assisted Endotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Procedure Start', 'timeFrame': 'up to 1 hour', 'description': 'Time from patient entry into procedure room to insertion of endoscope/start of procedure'}], 'secondaryOutcomes': [{'measure': "Intubation Time (time from 'ready to intubate', to 'tube confirmation')", 'timeFrame': 'up to 1 hour', 'description': 'Endoscopy documentation'}, {'measure': 'Patient positioning time', 'timeFrame': 'up to 1 hour', 'description': 'Recorded in endoscopy suite'}, {'measure': 'Staff required for patient positioning', 'timeFrame': 'up to 20 minutes', 'description': 'Recorded in endoscopy suite, # of staff'}, {'measure': 'Staff survey/assessment of ergonomic strain', 'timeFrame': 'up to 1 hour', 'description': 'Staff reporting of ergonomic strain encountered during the procedure scale of 1-5 to rate ergonomic strain,'}, {'measure': 'Need for special positioning equipment', 'timeFrame': 'up to 20 minutes', 'description': 'Documented based on procedure room observation, list of equipment'}, {'measure': 'Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension', 'timeFrame': 'up to 20 minutes', 'description': 'Evaluation of hypoxia during intubation'}, {'measure': 'Time from removal of GI endoscope to exit from procedure room', 'timeFrame': 'up to 60 minutes', 'description': 'Documented in endoscopy suite'}, {'measure': 'Tooth/oropharyngeal trauma, skin/musculoskeletal trauma', 'timeFrame': 'up to 24 hours post-procedure', 'description': 'Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage)'}, {'measure': 'Materials and facility fees', 'timeFrame': 'up to 24 hours post-procedure', 'description': 'assessment of cost associated with procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'Endoscopic Procedures', 'Anesthesia'], 'conditions': ['Biliary Tract Diseases', 'Pancreatic Diseases']}, 'referencesModule': {'references': [{'pmid': '36878302', 'type': 'DERIVED', 'citation': 'Barakat MT, Angelotti T, Ghosh S, Banerjee S. Prospective randomized comparison of endoscopist-facilitated endotracheal intubation and standard intubation for ERCP. Gastrointest Endosc. 2023 Sep;98(3):441-447. doi: 10.1016/j.gie.2023.02.032. Epub 2023 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation', 'detailedDescription': "Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table.\n\nAt our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe.\n\nWe hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing ERCP at Stanford University Medical Center\n\nExclusion Criteria:\n\n* Unable to consent\n* Contra-indication to general anesthesia'}, 'identificationModule': {'nctId': 'NCT03879720', 'briefTitle': 'Comparison of Standard and Endoscope Assisted Endotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]', 'orgStudyIdInfo': {'id': '47089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Endotracheal Intubation (SEI)', 'description': 'the patient will be positioned supine on the gurney for intubation, with eventual position in the standard semi-prone ERCP position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed, Propofol and Succinylcholine will be administered per standard of care and intubation will be accomplished by direct laryngoscopy or glidescope, with confirmation of endotracheal tube placement by auscultation.', 'interventionNames': ['Procedure: Endoscope assisted endotracheal intubation [EAEI]']}, {'type': 'EXPERIMENTAL', 'label': 'Endoscope assisted endotracheal intubation [EAEI]', 'description': 'the patients will position themselves in the semi-prone position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed and Propofol will be administered per standard of care. Succinylcholine will not be administered and therefore the patient will not be paralyzed. The endotracheal tube will be positioned on the mid-distal aspect of the ultra-slim endoscope and the ultra-slim endoscope will then be advanced into the trachea under direct endoscopic visualization to the level of the carina. The anesthesiologist will then advance the endotracheal tube over the endoscope into the trachea, and its position above the carina will be simultaneously confirmed endoscopically with the ultra-slim endoscope.', 'interventionNames': ['Procedure: Endoscope assisted endotracheal intubation [EAEI]']}], 'interventions': [{'name': 'Endoscope assisted endotracheal intubation [EAEI]', 'type': 'PROCEDURE', 'otherNames': ['Standard Endotracheal Intubation [SEI]'], 'description': 'Endoscope assisted endotracheal intubation \\[EAEI\\] performed by anesthesiologist with endoscopist assistance.', 'armGroupLabels': ['Endoscope assisted endotracheal intubation [EAEI]', 'Standard Endotracheal Intubation (SEI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Subhas Banerjee', 'role': 'CONTACT', 'email': 'sbanerje@stanford.edu', 'phone': '650-723-2623'}], 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Subhas Banerjee', 'role': 'CONTACT', 'email': 'sbanerje@stanford.edu', 'phone': '650-723-2623'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Subhas Banerjee', 'investigatorAffiliation': 'Stanford University'}}}}