Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT01539135
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2012-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008751', 'term': 'Methylene Blue'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sabrina.bent@hcahealthcare.com', 'phone': '5049887137', 'title': 'Dr. Sabrina Bent', 'organization': 'Tulane University Hospital and Clinics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "This was a feasibility study and based on the results, we do not believe that a larger, multicenter randomized controlled trial would be appropriate. The study wasn't powered to find any significant differences."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dye Leakage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'OG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of surgical procedure - from 2 to 12 hours', 'description': 'Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'OG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time from discharge from PACU to discharge from hospital up to 72 hours', 'description': 'Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'OG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Unanticipated Intensive Care Unit Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'OG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from discharge from PACU to discharge from hospital up to 72 hours', 'description': 'Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'FG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hi-Lo Endotracheal Tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'BG001', 'title': 'TaperGuard Endotracheal Tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure\n\nMethylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age: \\>18years Gender, male, female', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '56', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2012-02-06', 'resultsFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2012-02-21', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-05', 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dye Leakage', 'timeFrame': 'Duration of surgical procedure - from 2 to 12 hours', 'description': 'Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.'}], 'secondaryOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'Time from discharge from PACU to discharge from hospital up to 72 hours', 'description': 'Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.'}, {'measure': 'Number of Participants With Postoperative Pneumonia', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery'}, {'measure': 'Number of Participants With Unanticipated Intensive Care Unit Admission', 'timeFrame': 'Time from discharge from PACU to discharge from hospital up to 72 hours', 'description': 'Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aspiration, Respiratory'], 'conditions': ['Respiratory Aspiration']}, 'descriptionModule': {'briefSummary': 'Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.', 'detailedDescription': 'This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes. The TaperGuard Basic tube has a taper-shaped cuff and has been shown, via bench and animal testing, to decrease microaspiration, which has been associated with respiratory difficulties. The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated. This study will determine whether the intraoperative use of the TaperGuard tube results in a decrease in microaspiration compared to the Hi-Lo endotracheal tube having a barrel-shaped cuff. Moreover, the relationship between a decrease in microaspiration and subsequent decrease in postoperative respiratory complications will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female of all races\n* Older than 18 years old\n* Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route\n* Willing and able to give informed consent for participation in the study\n* Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU\n* Expected hospital stay of greater than or equal to 23hrs\n\nExclusion Criteria:\n\n* Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery\n* Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery\n* Surgical requirement for naso-tracheal intubation\n* Patients undergoing surgical procedures directly on the lungs, trachea, or airways\n* Presence of tracheostomy\n* History of allergic reaction to methylene blue\n* Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency\n* Renal insufficiency or failure\n* Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission\n* Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time\n* Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).\n* Patients younger than 18 years of age\n* Prone positioning during surgery\n* Pregnant or lactating women based on standardized preoperative screening protocols\n* Legally detained prisoner status\n* Unwilling or unable to give informed consent for participation in the study'}, 'identificationModule': {'nctId': 'NCT01539135', 'briefTitle': 'The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications', 'orgStudyIdInfo': {'id': 'COVAIPR0235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hi-Lo endotracheal tube', 'description': 'Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure', 'interventionNames': ['Drug: Methylene Blue']}, {'type': 'EXPERIMENTAL', 'label': 'TaperGuard endotracheal tube', 'description': 'TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure', 'interventionNames': ['Drug: Methylene Blue']}], 'interventions': [{'name': 'Methylene Blue', 'type': 'DRUG', 'otherNames': ['Methylene Blue Dye'], 'description': '20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure', 'armGroupLabels': ['Hi-Lo endotracheal tube', 'TaperGuard endotracheal tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Hospital and Clinics', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Sabrina Bent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}