Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-18 @ 2:36 AM
Study NCT ID:
NCT01885793
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracuff pressure', 'timeFrame': 'Immediately after intubation', 'description': 'Intracuff pressure is measured via handheld manometer and by using the transducer of an invasive pressure monitoring device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia Intubation Complication']}, 'descriptionModule': {'briefSummary': 'This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical patients that require endotracheal intubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubation of trachea with a cuffed endotracheal tube.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01885793', 'briefTitle': 'Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB13-00107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cuffed endotracheal tube', 'description': 'Surgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT).', 'interventionNames': ['Device: Cuffed endotracheal tube']}], 'interventions': [{'name': 'Cuffed endotracheal tube', 'type': 'DEVICE', 'description': 'Intubation with a cuffed endotracheal tube (ETT).', 'armGroupLabels': ['Cuffed endotracheal tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Senthil Gopalakrishnan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Senthil G. Krishna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Senthil G. Krishna', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}