Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT01651260
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of an Endotracheal Tube Securement Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'malford.cullum@Hollister.com', 'phone': '847-918-3975', 'title': 'Malford Cullum', 'organization': 'Hollister Incorporated'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Adult subjects in respiratory insufficiency in ICU setting were intubated with only four ET tube sizes: 7.0, 7.5, 8.0 and 8.5 mm. No other sizes were represented in the sample population.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hollister ET Tube Securement Device', 'description': 'Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.', 'otherNumAtRisk': 65, 'otherNumAffected': 4, 'seriousNumAtRisk': 65, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Ulcer on tongue', 'notes': 'Ulcer on tongue possibly related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper lip breakdown', 'notes': 'Upper lip ulcer probably related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound on upper palette', 'notes': 'Wound on upper palette probably related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding tongue.', 'notes': 'Patient forced tongue to opposite side of jaw and bit the tongue. Unrelated to the device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Obstruction of ET tube', 'notes': 'Blood oxygen saturation (SpO2) dropped from 100% to 60% due to patient biting ET tube. Unrelated to the device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Loosened teeth', 'notes': 'Three upper teeth loose. Probably related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Patient on terminal wean expired with device in place. Unrelated to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Patient on terminal wean expired with device in place. Unrelated to device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hollister Endotracheal (ET) Tube Securement Device', 'description': 'Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.'}], 'classes': [{'title': 'Damage to ET tube', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Occlusion of ET Tube', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'upper probability of failure', 'paramValue': '.05', 'pValueComment': 'Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.', 'estimateComment': 'Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Number of participants with damage of ET tube and Number of participants with occlusion of ET tube', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hollister ET Tube Securement Device', 'description': 'Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between 1 - 14 days', 'description': 'Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);', 'unitOfMeasure': '% rating with score of 4 and 5', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hollister ET Tube Securement Device', 'description': 'Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'unable to apply product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects were recruited between July 2012 to February 2013 in the ICU setting at 6 hospitals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hollister ET Tube Securement Device', 'description': 'Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '15.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Reason for intubation', 'classes': [{'title': 'Respiratory Failure', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Post-operative', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Complete demographic profiles were obtained for 63 participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2012-07-16', 'resultsFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-22', 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use', 'timeFrame': '14 days', 'description': 'Number of participants with damage of ET tube and Number of participants with occlusion of ET tube'}], 'secondaryOutcomes': [{'measure': 'Ease of Use', 'timeFrame': 'Between 1 - 14 days', 'description': 'Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.', 'detailedDescription': 'This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is 18 years of age or older; male or female and requiring oral tracheal intubation.\n* Has intact skin on application site.\n* Willingly signs or their authorized representative willingly signs the Informed Consent.\n* Is qualified to participate in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Has an existing neck injury.\n* Has protruding upper teeth, without teeth or is unable to wear upper dentures.\n* Has facial hair.\n* Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.\n* Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.\n* Has a known or stated allergy to adhesive bandages, or any of the product types being tested.\n* Uses of topical drugs on the application site.\n* Uses lotions, creams or oils on the application site.\n* Currently is participating in any clinical testing which may affect performance of this device.\n* Has been previously intubated with skin irritation or pressure sores surrounding the mouth.'}, 'identificationModule': {'nctId': 'NCT01651260', 'briefTitle': 'Assessment of an Endotracheal Tube Securement Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device', 'orgStudyIdInfo': {'id': '5156-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Endotracheal (ET) tube securement device', 'description': 'Single arm study evaluated an experimental ET tube securement device with a bite block.', 'interventionNames': ['Other: Experimental ET Tube Securement Device']}], 'interventions': [{'name': 'Experimental ET Tube Securement Device', 'type': 'OTHER', 'otherNames': ['AnchorFast Guard® ET tube securement device'], 'description': 'Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.', 'armGroupLabels': ['Endotracheal (ET) tube securement device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Hospitals", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Good Samaritan', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '98686', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Legacy Salmon Creek Medical Center', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'Elizabeth Konz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hollister Incorporated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}