Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 2:37 PM
Study NCT ID:
NCT03992950
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2019-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusion of the esophagus', 'timeFrame': 'During 1 minute under videolaryngoscopy', 'description': "Occlusion of the esophagus is checked with the application of cricoid and paratracheal pressures using esophageal stethoscope. If the esophageal stethoscope is not advanced into the esophagus, it is considered 'occlusion'."}], 'secondaryOutcomes': [{'measure': 'Outer diameter of the esophagus', 'timeFrame': 'During 1 minute after injection of anesthetics during induction of anesthesia', 'description': 'Outer diameter of the esophagus is measured using ultrasound before and after the application of cricoid and paratracheal pressures.'}, {'measure': 'Position of the oesophageal entrance relative to the glottis', 'timeFrame': 'During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy', 'description': 'Position of the oesophageal entrance relative to the glottis is evaluated.'}, {'measure': 'Position of the upper oesophagus relative to the trachea', 'timeFrame': 'During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy', 'description': 'Position of the upper oesophagus relative to the trachea trachea is evaluated.'}, {'measure': 'The best laryngeal view', 'timeFrame': 'Before and after the application of cricoid and paratracheal force during videolaryngoscopy', 'description': 'The best laryngeal view is evaluated using the percentage of glottis opening (POGO) score, ranging from 0% to 100%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '35913721', 'type': 'DERIVED', 'citation': 'Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effectiveness of Cricoid and Paratracheal Pressures in Occluding the Upper Esophagus Through Induction of Anesthesia and Videolaryngoscopy: A Randomized, Crossover Study. Anesth Analg. 2022 Nov 1;135(5):1064-1072. doi: 10.1213/ANE.0000000000006154. Epub 2022 Aug 1.'}]}, 'descriptionModule': {'briefSummary': "Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy", 'detailedDescription': 'The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study\n\nExclusion Criteria:\n\n* Risk of aspiration\n* History of esophageal surgery\n* Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus\n* Known or predicted difficult airway.'}, 'identificationModule': {'nctId': 'NCT03992950', 'briefTitle': 'Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During the Induction of Anesthesia', 'orgStudyIdInfo': {'id': 'P2019-195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cricoid pressure', 'description': 'Cricoid pressure is applied in the anesthetized state and during video laryngoscopy', 'interventionNames': ['Other: Maneuvers for occluding esophagus']}, {'type': 'EXPERIMENTAL', 'label': 'Paratracheal pressure', 'description': 'Paratracheal pressure is applied in the anesthetized state and during video laryngoscopy', 'interventionNames': ['Other: Maneuvers for occluding esophagus']}], 'interventions': [{'name': 'Maneuvers for occluding esophagus', 'type': 'OTHER', 'description': 'Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level', 'armGroupLabels': ['Cricoid pressure', 'Paratracheal pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}