NCT03535155

Brief Summary

The overall aim of this study is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success. This is a prospective cohort study to evaluate the accuracy of the automated spinal landmark identification technique using image processing system based on identification by experienced investigator using ultrasound in subjects requiring spinal anesthesia.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2016

Longer than P75 for all trials

Status
active not recruiting

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

Study Progress95%
May 2016Dec 2026

Study Start

First participant enrolled

May 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

May 13, 2018

Last Update Submit

October 8, 2024

Conditions

Spinal Anesthesia

Keywords

Ultrasound image, Neuraxial anesthesia, Landmark

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate of spinal anaesthesia

    First attempt success rate of spinal anaesthesia

    12 hours

Secondary Outcomes (3)

  • Number of spinal attempts

    12 hours

  • Time taken to identify the ligamentum flavum in the transverse view

    12 hours

  • Distance from skin to ligamentum flavum

    12 hours

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The women whose age between 21-75 years old who required spinal anaesthesia for surgical procedure.

You may qualify if:

  • Age between 21-75 years old who required spinal anesthesia for surgical procedure;
  • Weight of 40-90kg and height of 140-180cm;
  • BMI less than 30.

You may not qualify if:

  • History of scoliosis;
  • History of spinal instrumentation;
  • Drug allergy to ultrasound transmission gel;
  • Visible wound or injury in the lumbar spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Oh TT, Ikhsan M, Tan KK, Rehena S, Han NR, Sia ATH, Sng BL. A novel approach to neuraxial anesthesia: application of an automated ultrasound spinal landmark identification. BMC Anesthesiol. 2019 Apr 16;19(1):57. doi: 10.1186/s12871-019-0726-6.

    PMID: 30991949DERIVED

Study Officials

  • Ban Leong Sng, MBBS, MMED

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 13, 2018

First Posted

May 24, 2018

Study Start

May 1, 2016

Primary Completion

April 1, 2017

Study Completion (Estimated)

December 31, 2026

Last Updated

October 9, 2024

Record last verified: 2024-10