Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 1:33 AM
Study NCT ID:
NCT01415232
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vallejomc@anes.upmc.edu', 'phone': '4126414260', 'title': 'Dr. Manuel Vallejo', 'organization': "UPittsburgh'"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ultrasound Measurement', 'description': 'Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.', 'otherNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Measurement', 'description': 'Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients'}], 'classes': [{'title': 'Ultrasound Longitudinal Plane', 'categories': [{'measurements': [{'value': '0.905', 'groupId': 'OG000', 'lowerLimit': '0.873', 'upperLimit': '0.929'}]}]}, {'title': 'Ultrasound Transverse Plane', 'categories': [{'measurements': [{'value': '0.899', 'groupId': 'OG000', 'lowerLimit': '0.865', 'upperLimit': '0.925'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.87', 'ciUpperLimit': '0.93', 'groupDescription': "Pearson's correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.", 'statisticalMethod': 'longitudinal correlation coefficient', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': "Balki et al found a Pearson's correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled."}, {'pValue': '>0.85', 'groupIds': ['OG000'], 'paramType': 'transverse plane correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.87', 'ciUpperLimit': '0.93', 'groupDescription': 'Transverse plane correlation coefficient', 'statisticalMethod': 'transverse plane correlation coefficient', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'correlation coefficient'}, {'pValue': '>0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.64', 'ciLowerLimit': '6.5', 'ciUpperLimit': '6.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.0', 'groupDescription': 'Clinical epidural needle depth', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.05', 'groupIds': ['OG000'], 'paramType': 'Formula calculation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.54', 'ciLowerLimit': '6.44', 'ciUpperLimit': '6.65', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.68', 'estimateComment': 'Estimated epidural depth equation depth (cm)', 'groupDescription': 'Estimated epidural depth equation depth (cm)', 'statisticalMethod': 'Formula calculation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)', 'description': 'Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.', 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultrasound Measurement', 'description': 'Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From August 2010 to June 2011, a total of 160 parturients from Magee-Womens Hospital of UPMC.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultrasound Measurement', 'description': 'Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2011-08-09', 'resultsFirstSubmitDate': '2013-02-01', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-03-19', 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)', 'timeFrame': 'at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)', 'description': 'Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Ultrasound'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the correlation between actual epidural needle depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the best of our knowledge the use of an epidural depth equation, which was developed in an earlier study using height and weight, with ultrasound visualization will improve identification of the epidural space.', 'detailedDescription': "The investigators plan to enroll women who are morbidly obese (BMI \\> 40 kg/m2) and request epidural analgesia for labor. After written informed consent, 160 patients will have the use of the epidural depth equation with ultrasound (EQ-US) to estimate epidural depth (Est-D). US visualization of the epidural space will be completed by the principle investigator who has had extensive training in epidural US visualization. The EQ-US depth will be recorded. After US use, another provider who is listed as an investigator will place the epidural catheter without prior knowledge of the estimated epidural depth with the use of the equation and US. The actual needle depth to the epidural space (ND) will be recorded.\n\nData collected from the patient's medical record will include demographic data (age, height, weight) gravidity, parity, and cervical dilation. Measured variables will include the estimated epidural depth (Est-D) as measured by the epidural depth equation with the use of ultrasound (EQ-US), and actual epidural needle depth (ND). The investigators believe that the use of ultrasound with the epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients will have a high correlation with actual epidural needle depth (ND)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll women of childbearing age (including children aged 14 years and above) with a BMI \\> 40kg/m2 who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study. Men will not be included since they can not become pregnant. All patients will be recruited at Magee-Womens Hospital.\n\nExclusion Criteria:\n\nPatients with severe preeclampsia will be excluded from the study, as these patients may have significant edema which could alter ultrasound and/or epidural needle depth measurement. Patients with a history of back surgery, significant scoliosis, and/or lumbar pathology (i.e. Ankylosing Spondylitis) will be excluded from the study because these conditions could complicate ultrasound visualization and/or epidural needle placement.'}, 'identificationModule': {'nctId': 'NCT01415232', 'briefTitle': 'A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'The Use of Ultrasound With the Epidural Depth Equation (EQ-US) to Estimate Epidural Depth (Est-D) in Morbidly Obese Parturients (BMI>40Kg/m2) Will Have a High Correlation With Actual Epidural Needle Depth (ND)', 'orgStudyIdInfo': {'id': 'PRO10070214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound measurement', 'description': 'Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.', 'interventionNames': ['Device: Sonosite S-Nerve® US system (SonoSite, Bothell,WA)']}], 'interventions': [{'name': 'Sonosite S-Nerve® US system (SonoSite, Bothell,WA)', 'type': 'DEVICE', 'otherNames': ['Ultrasound machine', 'Sonosite'], 'description': 'Ultrasound to measure depth to the epidural space in morbidly obese parturients', 'armGroupLabels': ['Ultrasound measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Manuel C. Vallejo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manuel C. Vallejo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Manuel C. Vallejo', 'investigatorAffiliation': 'University of Pittsburgh'}}}}