Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 1:58 PM
Study NCT ID:
NCT01285804
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2011-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-27', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.', 'timeFrame': '4-5 minutes after induction', 'description': 'The oxygen and sevoflurane (anesthetic agent) concentration of the oropharynx would be measured during positive pressure ventilation immediately after intubation and then 4-5 mins. after anesthetic induction when the patient resumes spontaneous ventilation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adenoidectomy', 'Tonsillectomy', 'Adenotonsillectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.\n\nExclusion Criteria:\n\n* Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.'}, 'identificationModule': {'nctId': 'NCT01285804', 'briefTitle': 'Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB10-00487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cuffed ETT', 'interventionNames': ['Other: Cuffed ETT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Uncuffed ETT', 'interventionNames': ['Other: Uncuffed ETT']}], 'interventions': [{'name': 'Cuffed ETT', 'type': 'OTHER', 'description': 'Kimberly Clark', 'armGroupLabels': ['Cuffed ETT']}, {'name': 'Uncuffed ETT', 'type': 'OTHER', 'description': 'Kimberly Clark', 'armGroupLabels': ['Uncuffed ETT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}