Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT03558633
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusion of esophagus', 'timeFrame': 'for 1 minute during direct laryngosopy', 'description': 'Occlusion of esophagus is checked under the application of cricoid and paralaryngeal pressures during direct laryngsocpy'}], 'secondaryOutcomes': [{'measure': 'The relative position of the upper esophageal end to the glottis', 'timeFrame': '1 minute before and after the induction of anesthesia, during direct laryngoscopy', 'description': 'The position assessed by using ultrasonography and direct visualization'}, {'measure': 'The outer anteroposterior diameter of the upper esophageal end', 'timeFrame': 'During 1 minute in awake and anesthetized paralyzed states', 'description': 'The outer anteroposterior diameter of the upper esophageal end is assessed before and durng the application of cricoid and paralaryngeal pressures.'}, {'measure': 'POGO score', 'timeFrame': 'during direct laryngoscopy', 'description': 'POGO score under the application of cricoid and paralaryngeal pressures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cricoid pressure', 'Paralaryngeal pressure', 'Intubation'], 'conditions': ['Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '8424572', 'type': 'BACKGROUND', 'citation': 'Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.'}, {'pmid': '17122571', 'type': 'BACKGROUND', 'citation': 'Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.'}, {'pmid': '21287147', 'type': 'BACKGROUND', 'citation': 'Koenig SJ, Lakticova V, Mayo PH. Utility of ultrasonography for detection of gastric fluid during urgent endotracheal intubation. Intensive Care Med. 2011 Apr;37(4):627-31. doi: 10.1007/s00134-010-2125-9. Epub 2011 Feb 2.'}]}, 'descriptionModule': {'briefSummary': "Comparing the effects of ' Cricoid pressure' or 'Paralaryngeal pressure' during endotracheal intubation procedure.", 'detailedDescription': "Applying Cricoid pressure is widely used procedure to prevent gastric contents regurgitation during endotracheal intubation. To find out effectiveness external pressure is applied, the investigators will evaluate the relative position of esophagus and trachea. And also comparing the effects of Cricoid pressure and Paralaryngeal pressure during whole tracheal intubation procedures.\n\n1. Confirm the relative positions between esophagus and trachea in awake patients by using ultrasonography.\n2. Compare the effect of 'Cricoid pressure' and 'Paralaryngeal pressure' to esophageal opening during tracheal intubation procedure as below points.\n\n1\\) Awake states. (Before sedation) 2) Anesthetized states. (After muscle relaxation) 3) During direct intubation procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Who has any surgery under general anesthesia and agree with the purpose of the study', '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* Diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus,\n* Aspiration tendency\n* Known or predicted difficult airway.'}, 'identificationModule': {'nctId': 'NCT03558633', 'briefTitle': 'Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'A Comparison of the Effects of Cricoid Pressure and Paralaryngeal Pressure to Prevent Regurgitation of Gastric Contents', 'orgStudyIdInfo': {'id': '20180222/30-2018-11/033'}}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Department of Anesthesiology and Pain medicine', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}