Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 6:56 PM
Study NCT ID:
NCT03716466
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Prophylactic Endotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular unplanned event', 'timeFrame': 'Postoperative up to 48 hours', 'description': 'The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours'}], 'secondaryOutcomes': [{'measure': 'Pulmonary unplanned event', 'timeFrame': 'Postoperative up to 48 hours', 'description': 'The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation;Difficult', 'Gastrointestinal Bleeding']}, 'descriptionModule': {'briefSummary': 'Upper gastrointestinal (GI) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. These patients have risk of aspiration of blood along with gastric content. The mortality rate can be 15% to 20% in the cases with variceal bleeding. From a practical standpoint, it is widely accepted that the best way to secure an airway during upper GI bleeding is prophylactic endotracheal intubation (PEI). The aim of this study is to determine the incidence of complications among critically ill patients with upper GI bleeding and received urgent endoscopy.', 'detailedDescription': 'This is a prospective observational study. After IRB approval, consecutive patient with upper GI bleeding and undergoing urgent endoscopy will be enrolled to the study over 24 months period. Data pull will be requested from Parkland Office of Research Administration (ORA) regarding eligible subjects and protocol requiring data elements. The data pull will be requested at the end of the 24 months-period.\n\nPrimary endpoint:\n\nThe incidence of cardiovascular unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.\n\nSecondary end points:\n\nThe incidence of pulmonary unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases with upper gastrointestinal bleeding.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Presence of upper gastrointestinal bleeding either presented with hematemesis or melena along with evidence of hemodynamic compromise.\n* Received procedural (conscious) sedation\n* Undergoing urgent upper gastrointestinal endoscopy procedures\n\nExclusion Criteria:\n\n* Intubation other than airway protection\n* Prior tracheostomy before onset of gastrointestinal bleeding\n* Subjects intubated before transfer to gastrointestinal suite\n* Subjects without hemodynamic instability\n* Subjects with a diagnosis of pneumonia, acute respiratory distress syndrome, myocardial infarction, pulmonary edema, arrhythmia, or cardiac arrest before endoscopy\n* Endoscopy done for other than upper gastrointestinal bleeding\n* Pregnant subjects'}, 'identificationModule': {'nctId': 'NCT03716466', 'briefTitle': 'Evaluation of Prophylactic Endotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'STU 072018-045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endotracheal intubation', 'description': 'Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .', 'interventionNames': ['Other: Endotracheal intubation']}, {'label': 'No airway intervention', 'description': 'Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding', 'interventionNames': ['Other: No airway intervention']}], 'interventions': [{'name': 'Endotracheal intubation', 'type': 'OTHER', 'description': 'Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure', 'armGroupLabels': ['Endotracheal intubation']}, {'name': 'No airway intervention', 'type': 'OTHER', 'description': 'Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure', 'armGroupLabels': ['No airway intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Health Hospital System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'David Nasir, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': '214-590-5352'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOC PROFESSOR', 'investigatorFullName': 'Dawood Nasir', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}