Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Pregnancy

Ultrasound Clinical Trial

— Accuro  

Official title:

Accuracy of Real Time 3D Navigation Device to Identify Lumbar Epidural Spacy in Pregnant Patients. A Comparison With Standard Ultrasound.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164369
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 23, 2017
• Start date: April 1, 2017
• Est. completion date: May 2, 2017

Study information

• Verified date: May 2017
• Source: Città di Roma Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this double blinded study is to assess the abilities of the SpineNav3DTM technology (Accuro) to identify the lumbar epidural space in parturients using as comparator a standar ultrasound (US) device.

Description:

SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant women undergoing antenatal anesthetic consultation

Exclusion Criteria:

Related Conditions & MeSH terms

• Ultrasound

Locations

Country	Name	City	State
Italy	Citta di Roma Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Città di Roma Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidural space depth	measurement of the depth of the epidural space	day 1