NCT04395573

Brief Summary

The aim of this study is to assess the accuracy of the Accuro Ultrasound Device in estimating the epidural space depth compared to the Standard Ultrasound Examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

May 14, 2020

Last Update Submit

August 23, 2021

Conditions

Pregnancy RelatedObesity

Outcome Measures

Primary Outcomes (1)

  • Epidural space depth

    the depth of the epidural space (recorded in cm) is defined as the distance from the skin to the posterior complex

    up to 30 minutes

Interventions

AccuroDEVICE

ultrasound device (Accuro, Rivanna Medical, Charlottesville, VA) with automated pattern recognition software programmed (SpineNav3DTM technology) to calculate the depth to epidural space and identify bony landmarks

Also known as: wireless portable ultrasound device
standard ultrasound deviceDEVICE

standard ultrasound device (o calculate the depth to epidural space and identify bony landmarks

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant patients
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant Patients undergoing elective cesarean section or requesting labor epidural analgesia

You may qualify if:

  • ASA Status \>III
  • obese BMI\>30
  • term gestatio \> 37 weeks
  • singleton pregnancy
  • undergoing elective cesarean section with spinal anesthesia
  • requesting epidural labor analgesia

You may not qualify if:

  • contraindications to neuraxial block
  • severe scoliosis
  • previous spine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST S Gerardo

Monza, Italy

Location

Related Publications (1)

  • Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.

    PMID: 28858898BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giorgio Capogna, MD

    European e-Learning School in Obstetric Anesthesia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 20, 2020

Study Start

March 30, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)