Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03433612
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The estimation marks from each technique (two total) will be on the back of the patient (one on the left flank, one on the right flank), therefore the patient does not know where the marks are. Additionally, each mark will be covered with a taped on gauze pad to conceal it so that the two investigators are blinded to each others assessment. The ultrasound clinician will be masked to the two estimations. The marks will still remain covered while the interspace is determined by the third assessor using lumbar ultrasound.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will undergo estimation of the L4-L5 interspace using the classic and novel technique, followed by identification of the interspace using lumbar ultrasound.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace', 'timeFrame': 'From enrollment to the end of data collection, approximately 15 minutes', 'description': 'Percentage of trials for the novel and classic technique respectively that the estimation correctly matches the L4-L5 interspace as determined by lumbar paramedian ultrasound will serve as a measure of accuracy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anatomical Landmarks'], 'conditions': ['Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '31831599', 'type': 'DERIVED', 'citation': 'Pancaro C, Rajala B, Vahabzadeh C, Cassidy R, Klumpner TT, Kountanis JA, McCabe M, Rector D, Aman C, Sankar K, Schoenfeld R, Engoren M. Sacral anatomical interspace landmark for lumbar puncture in pregnancy: A randomized trial. Neurology. 2020 Feb 11;94(6):e626-e634. doi: 10.1212/WNL.0000000000008749. Epub 2019 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL technique compared to the classic intercristal line technique in estimating the L4-L5 interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace in pregnant women than the classic intercristal line technique.', 'detailedDescription': 'The current standard technique aiming at identifying the L4-L5 intervertebral space as a reference point before performing a neuraxial block relies on the correct clinical estimation of the intercristal line. The classic intercristal line technique uses an imaginary line that intersects the iliac crests to determine a safe puncture level to access. In pregnant women, the classic technique fails to identify the safe puncture level 40 % of the time.\n\nThe newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.\n\nLumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultrasound-determined gestation age greater than or equal to 37 weeks\n* Expressed interest or indication for epidural anesthesia\n* Patients in the first stage of labor\n\nExclusion Criteria:\n\n* Patients perceived or indicating that she is unable to cooperate with positioning\n* BMI greater than 45 kg/m2\n* Previous spine surgery or known spinal deformities\n* Impaired decision making abilities\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT03433612', 'acronym': 'SAIL', 'briefTitle': 'Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Novel Method of Improving Accuracy of Anatomical Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique', 'orgStudyIdInfo': {'id': 'HUM00109509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Patients', 'description': 'Estimates of the location of the L4-L5 intervertebral space will be done by the classic intercristal line technique and novel SAIL technique. Each technique will be performed by different randomly assigned investigators.\n\n\\* Both techiques will be assessed on all patients', 'interventionNames': ['Other: Classic Intercristal Line Technique', 'Other: Novel SAIL Technique']}], 'interventions': [{'name': 'Classic Intercristal Line Technique', 'type': 'OTHER', 'otherNames': ['Standard of Care'], 'description': 'Researcher will use the classic technique to estimate the L4-L5 interspace. The classic technique begins by palpating both the right and left posterior iliac crests and following the imaginary line that intersects each (intercristal line) with the non-dominant hand to the spine where it is estimated to intersect the L4 spinous process or L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique.', 'armGroupLabels': ['All Patients']}, {'name': 'Novel SAIL Technique', 'type': 'OTHER', 'otherNames': ['Experimental'], 'description': 'Researcher will use the novel technique to estimate the L4-L5 interspace. The SAIL technique begins by palpating the sacrum and the researcher sliding the non-dominant hand up the dorsal surface of the sacrum to the first interspace (L5-S1) and then up one more interspace to estimate the L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique.', 'armGroupLabels': ['All Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Carlo Pancaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Obstetrical Anesthesiology', 'investigatorFullName': 'Carlo Pancaro', 'investigatorAffiliation': 'University of Michigan'}}}}