Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT01415661
Status:
COMPLETED
Last Update Posted:
2012-04-10
First Post:
2011-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-07', 'studyFirstSubmitDate': '2011-08-04', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Cricoid Pressure for Prevention of Aspiration', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aspiration']}, 'descriptionModule': {'briefSummary': 'This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).', 'detailedDescription': "Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese patients ( BMI 40-70 kg/m2)\n* No Contre indication to cricoid pressure\n* No-obese patients (BMI \\< 40)\n\nExclusion Criteria:\n\n* ASA 3 and 4\n* Contre indication to cricoid pressure'}, 'identificationModule': {'nctId': 'NCT01415661', 'acronym': 'CP', 'briefTitle': 'Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study', 'organization': {'class': 'OTHER', 'fullName': 'Procare Riaya Hospital'}, 'officialTitle': 'Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study', 'orgStudyIdInfo': {'id': 'PRH 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'obese patient', 'interventionNames': ['Other: cricoid pressure']}, {'type': 'EXPERIMENTAL', 'label': 'non obese patient', 'interventionNames': ['Other: cricoid pressure']}], 'interventions': [{'name': 'cricoid pressure', 'type': 'OTHER', 'otherNames': ['Glidescope'], 'description': 'The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP.', 'armGroupLabels': ['non obese patient', 'obese patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31952', 'city': 'Khobar', 'state': 'Estern', 'country': 'Saudi Arabia', 'facility': 'procare Riaya Hospital', 'geoPoint': {'lat': 26.27944, 'lon': 50.20833}}], 'overallOfficials': [{'name': 'AHED ZEIDAN, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Procare Riaya Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procare Riaya Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ahed ZEIDAN', 'investigatorAffiliation': 'Procare Riaya Hospital'}}}}