Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Pregnancy
NCT ID: NCT03164369
Last Updated: 2017-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2017-04-01
2017-05-02
Brief Summary
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Detailed Description
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Assuming a Type I error rate of 5% (α = 0.05) and a Type II error rate of 20% (β=0.2), a minimum of 76 subjects will be required. All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two anesthesiologist, one expert in UD and the other a novice, previously instructed to the use of the Accuro device.
All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. The expert operator will assess the lumbar spine by using both the devices (standard US and Accuro) while the novice will use only the Accuro.
The primary end-point of the study will be the accuracy of the Accuro to determine the depth of the epidural space using a midline approach using as comparator the measurement obtained with the standard ultrasound device performed by the expert operator.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Città di Roma Hospital
OTHER
Responsible Party
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Giorgio Capogna
Head Department of Anesthesia
Principal Investigators
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Giorgio Capogna, MD
Role: STUDY_DIRECTOR
Citta di Roma Hospital
Locations
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Citta di Roma Hospital
Rome, , Italy
Countries
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Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id
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