An Ultrasound Guided Automated Spinal Landmark Identification System

NCT03687411 | Recruiting

• 1 other identifier: NHIC-I2D-1708180
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Neuraxial ultrasonography has been shown a safe and effective technique to enhance the overall success rate of lumbar puncture and reduce the number of injection attempts. However, the current blind palpation landmark technique is known to be highly inaccurate and may increase the risk of multiple insertion attempts, patient suffering and complication rates such as spinal cord injury. Various clinical studies have confirmed the effectiveness of ultrasound imaging compared with the traditional palpation method. However, none of the present system can achieve real-time guidance. The overall aim of this proposal is to develop an ultrasound guided automated spinal landmark identification with real-time neuraxial needle insertion system (uSINE) to improve patient safety and efficacy of neuraxial procedure needle insertion success. This will be achieved in 4 phases of technology development and clinical trial phases. The investigators will recruit 20 subjects in a prospective cohort study to investigate the spinal needle first attempt success rate as a clinically relevant outcome. The secondary aim is to develop an automated spinal landmark identification algorithm using image processing to identify spinal landmarks in 50 obese patients. Third phase objective will be to obtain clinical data, and evaluation and annotation of the clinical data of spinal ultrasonography in 65 obese patients (BMI \> 30kg/m2), whereas the fourth phase will measure the uSINE identification accuracy and first-attempt puncture success rate of uSINE in a clinical study of 65 obese patients (BMI \> 30kg/m2).

Conditions

Spinal Anaesthesia; Obesity

Keywords

spinal anaesthesia; Neuraxial ultrasonography; landmark identification

Outcome Measures

Primary Outcomes (1)

• First attempt success rate of spinal anaesthesia

  The rate of cases achieving successful spinal anaesthesia at first attempt of insertion

  12 hours

Secondary Outcomes (3)

• Number of spinal attempts

  12 hours

• Time taken for ligamentum flavum identification

  12 hours

• Distance from skin to ligamentum flavum

  12 hours

Study Arms (1)

ULTRA-SINE (phases 1-4)

EXPERIMENTAL

There will be four phases in this proposed uSINE system. In first phase attending anaesthetist will use the automated spinal landmark system for neuraxial needle insertion to place the neuraxial anaesthesia in non-obese patients. For the second phase, obese patients will have ultrasound scan of their lumbar back and no needle insertion is involved. In third phase, conventional ultrasonography is used prior to the needle insertion, and needle insertion is conducted manually as per routine practice. The images collected in the system will be used for annotation and evaluation which serves as training material for uSINE to optimize its algorithm to improve landmark identification for obese patients. The fourth phase will have uSINE system used prior to the needle insertion, with the neuraxial needle insertion conducted manually as per routine practice. The identification accuracy and first-attempt puncture success rate of uSINE will be determined.

Procedure: Neuraxial ultrasonography

Interventions

Neuraxial ultrasonography PROCEDURE

Ultrasound gel is applied to lower back lumbar spine of patient and placed with an ultrasound probe around the sacral region. The graphical interface of the software integrated with ultrasound machine will help identify the sacrum. The probe is moved in until the L3/4 interspinous space is identified for skin surface marking. Once the longitudinal scan is completed, the investigator will turn the probe 90° clockwise for transverse scan to identify ligamentum flavum.

ULTRA-SINE (phases 1-4)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Gender Eligibility Details: Only female undergoing surgery in the institution will be recruited (the mentioned institution provides healthcare services only to women and children)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First phase:
• Age 21 - 75 years old patients who require neuraxial anesthesia for surgical procedure;
• Normal body mass index (Weight 40-90 kg, Height 140-180cm).
• Second-fourth phases:
• Obese patients aged between 21-75 years old;
• body mass index more 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (1)

• In Chan JJ, Ma J, Leng Y, Tan KK, Tan CW, Sultana R, Sia ATH, Sng BL. Machine learning approach to needle insertion site identification for spinal anesthesia in obese patients. BMC Anesthesiol. 2021 Oct 18;21(1):246. doi: 10.1186/s12871-021-01466-8.

  PMID: 34663224 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ban L Sng, FANZCA

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ban L Sng, FANZCA

CONTACT

+6563941081; sng.ban.leong@singhealth.com.sg

Alex T Sia, MMED

CONTACT

+6563941081; alex.sia.t.h@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 27, 2018
• Study Start: May 24, 2018
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)