Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03479905
Status:
TERMINATED
Last Update Posted:
2024-08-13
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christina.Riccio@utsouthwestern.edu', 'phone': '214-590-7284', 'title': 'Christina Riccio', 'organization': 'UTexasSouthwestern'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': 'During hospital stay, an average of 6 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Salter Nasal Cannula', 'description': 'A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%\n\nSalter nasal cannula: Oxygen will be delivered by using standard nasal cannula', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Face Mask Group', 'description': 'A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.\n\nFace mask: Oxygen will be delivered via face mask during colonoscopy', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Flow Oxygen Delivery', 'description': 'Oxygen will be delivered by using high flow nasal cannula\n\nHigh Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oxygen Saturation (SpO2 )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Salter Nasal Cannula', 'description': 'A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%\n\nSalter nasal cannula: Oxygen will be delivered by using standard nasal cannula'}, {'id': 'OG001', 'title': 'Face Mask Group', 'description': 'A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.\n\nFace mask: Oxygen will be delivered via face mask during colonoscopy'}, {'id': 'OG002', 'title': 'High Flow Oxygen Delivery', 'description': 'Oxygen will be delivered by using high flow nasal cannula\n\nHigh Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative period, an average of 1 hour', 'description': 'The frequency of desaturation episodes (SpO2 \\<90%)', 'unitOfMeasure': 'Desaturation episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Salter Nasal Cannula', 'description': 'A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%\n\nSalter nasal cannula: Oxygen will be delivered by using standard nasal cannula'}, {'id': 'FG001', 'title': 'Face Mask Group', 'description': 'A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.\n\nFace mask: Oxygen will be delivered via face mask during colonoscopy'}, {'id': 'FG002', 'title': 'High Flow Oxygen Delivery', 'description': 'Oxygen will be delivered by using high flow nasal cannula\n\nHigh Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Other airway method used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Salter Nasal Cannula', 'description': 'A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%\n\nSalter nasal cannula: Oxygen will be delivered by using standard nasal cannula'}, {'id': 'BG001', 'title': 'Face Mask Group', 'description': 'A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.\n\nFace mask: Oxygen will be delivered via face mask during colonoscopy'}, {'id': 'BG002', 'title': 'High Flow Oxygen Delivery', 'description': 'Oxygen will be delivered by using high flow nasal cannula\n\nHigh Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.55', 'spread': '8.10', 'groupId': 'BG000'}, {'value': '58.23', 'spread': '6.73', 'groupId': 'BG001'}, {'value': '57.55', 'spread': '10.04', 'groupId': 'BG002'}, {'value': '57.44', 'spread': '8.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stop Bang Score', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG003', 'lowerLimit': '5', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Stop Bang Score for Obstructive Sleep Apnea on a scale of 0 to 8. A score of 2 or less is considered low risk, and a score of 5 or more is high risk for having either moderate or severe Obstructive Sleep Apnea.', 'unitOfMeasure': 'Stop Bang Score on a scale of 0 to 8', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Preoperative oxygen saturation (SpO2)', 'classes': [{'categories': [{'measurements': [{'value': '97.5', 'groupId': 'BG000', 'lowerLimit': '96', 'upperLimit': '98'}, {'value': '98', 'groupId': 'BG001', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '97', 'groupId': 'BG002', 'lowerLimit': '96', 'upperLimit': '98'}, {'value': '98', 'groupId': 'BG003', 'lowerLimit': '96', 'upperLimit': '98'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of oxygen saturation', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-12', 'size': 700548, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-06-27T17:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'whyStopped': 'Covid pandemia', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2018-03-20', 'resultsFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-17', 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Saturation (SpO2 )', 'timeFrame': 'Intraoperative period, an average of 1 hour', 'description': 'The frequency of desaturation episodes (SpO2 \\<90%)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Desaturation of Blood', 'Colonoscopy']}, 'descriptionModule': {'briefSummary': 'It is standard practice in the United States and many parts of world to perform Gastrointestinal endoscopy with the patient under deep intravenous sedation. Obesity is accepted as a patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic procedures. The obese population has a higher prevalence of obstructive sleep apnea (OSA), which is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. This prospective, randomized study was designed to compare the effectiveness of the high flow nasal cannula, standard nasal cannula and standard face mask in morbidly obese patients with a high risk of sleep apnea, (BMI greater than 40, STOPBANG greater or equal to 5) receiving deep intravenous sedation during colonoscopies. This study will assess which method leads to a lower incidence of intraoperative desaturation events compared to the current standard of care.', 'detailedDescription': 'The prevalence of morbid obesity is increasing worldwide. As the severity of obesity increases, the incidence of diagnosed obstructive sleep apnea also rises. Studies have shown an incidence of sleep apnea as high as 64% in patients with a body mass index (BMI) over 40 and 100% in patients with a BMI greater than 60. Patients with OSA have been shown to have significant desaturations under intravenous sedation due to airway narrowing and obstruction. Several studies have also shown that morbidly obese subjects, independent of a diagnosis of OSA, run a higher perioperative risk of adverse airway events, including hypoxia. Providing anesthesia for this patient population is challenging and requires careful titration of drugs and superb airway management skills.\n\nThe current standard of care for oxygen delivery in this setting is a Salter nasal cannula. Humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21% to 100% FiO2 delivery and generates up to 60 L/min flow rates. The gas is heated (35 to 40 degree Celsius) and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the subject through a large diameter nasal cannula. Theoretically, HFNC offers significant advantages in oxygenation and ventilation over conventional methods. Constant high flow oxygen delivery provides steady inspired oxygen fraction (FiO2) and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation.\n\nSome studies have demonstrated a positive effect of HFNC on the apnea-hypopnea index (AHI) showing that use of HFNC could decrease hypoxic episodes in subjects with repetitive upper airway obstruction such as obstructive sleep apnea. The STOP-BANG questionnaire (SB) has been used successfully to screen patients undergoing therapeutic endoscopic procedures at higher risk for sedation-related adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-80\n* Subjects undergoing colonoscopies\n* Morbidly obese BMI equal or greater than 40\n* STOPBANG score equal or greater than 5\n\nExclusion Criteria:\n\n* Subjects deemed hemodynamically unstable by the anesthesia team\n* Subjects who are an aspiration risk and will require endotracheal intubation.\n* Pregnancy\n* Subjects with an allergy to propofol\n* Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort\n* Subjects unwilling to sign consent\n* Patients that received medications other than lidocaine and propofol'}, 'identificationModule': {'nctId': 'NCT03479905', 'briefTitle': 'The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Prospective, Randomized Trial Comparing the Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients With High Risk of Obstructive Sleep Apnea Undergoing Colonoscopy', 'orgStudyIdInfo': {'id': 'STU 102017-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Salter nasal cannula', 'description': 'A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%', 'interventionNames': ['Other: Salter nasal cannula']}, {'type': 'SHAM_COMPARATOR', 'label': 'Face mask group', 'description': 'A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.', 'interventionNames': ['Other: Face mask']}, {'type': 'EXPERIMENTAL', 'label': 'High Flow Oxygen delivery', 'description': 'Oxygen will be delivered by using high flow nasal cannula', 'interventionNames': ['Device: High Flow Nasal Cannula']}], 'interventions': [{'name': 'Salter nasal cannula', 'type': 'OTHER', 'description': 'Oxygen will be delivered via standard nasal cannula during colonoscopy', 'armGroupLabels': ['Salter nasal cannula']}, {'name': 'Face mask', 'type': 'OTHER', 'otherNames': ['Standard Face Mask'], 'description': 'Oxygen will be delivered via face mask during colonoscopy', 'armGroupLabels': ['Face mask group']}, {'name': 'High Flow Nasal Cannula', 'type': 'DEVICE', 'otherNames': ['Device The Comfort Flo system'], 'description': 'A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.', 'armGroupLabels': ['High Flow Oxygen delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Helath Hospital System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Christina Riccio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christina Riccio', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}