Position and Angle Marking System (PAMS) for Ultrasound-guided Neuraxial Procedures

NCT04985279 | Unknown

• 1 other identifier: PAMS 2021/2159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural anaesthesia involves the administration of numbing medication (local anaesthetics) close to the spinal canal, and is regarded as the best method for providing pain relief during labour and childbirth. The use of ultrasound to guide epidural insertion and placement has been shown to improve pain relief and reduce the risk of complications. However, after identifying the desired needle insertion site via ultrasound, current practice involves demarcating the insertion site using marker pens, which is time-consuming, inaccurate, and may be inadvertently removed by skin sterilisation. Furthermore, the desired needle angulation determined by ultrasound cannot be accurately measured and maintained during the epidural procedure. Both issues limit the benefits of using ultrasound to guide the epidural procedure. To address these issues, the investigators developed a Position and Angular Marking System (PAMS) that attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure. The purpose of this randomised study is to evaluate the usability of PAMS and to identify areas for further improvement. This study will involve up to 10 healthy simulated patients, and up to 30 volunteer ultrasound operators. After undergoing a standardised training session with a mannequin, the ultrasound operators will be randomly assigned to perform skin marking on the simulated patients as though they are performing an ultrasound-guided epidural anaesthesia procedure (no needle puncture will be made) using either PAMS, or standard clinical practice with marker pens. After completing the procedure, the ultrasound operators will cross over and perform the procedure again using either PAMS or standard clinical practice with marker pens. Both the ultrasound operators and simulated patients will be asked to complete satisfaction and usability surveys regarding their experience with the procedures.

Conditions

Ultrasound-guided Neuraxial Procedures

Keywords

Ultrasonography; Epidural; Spinal; Labour analgesia

Outcome Measures

Primary Outcomes (1)

• Satisfaction survey of simulated patients and operators

  Satisfaction and feedback regarding the respective procedures

  Immediately after performing the procedure

Secondary Outcomes (1)

• Time taken to perform procedure

  Immediately after performing the procedure

Study Arms (2)

Standard clinical practice

ACTIVE COMPARATOR

* Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation using skin markers. * The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine. * The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle. * A usability questionnaire regarding the procedure will be completed.

Device: Standard clinical practice

Position and Angle Marking System (PAMS)

EXPERIMENTAL

* PAMS will be attached to the ultrasound probe. * Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation by gentle pressing PAMS into the simulated patient's back to create skin indentations. * The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine, and the angle read off a graduated scale. * The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle. * A usability questionnaire regarding the procedure will be completed.

Device: Position and Angle Marking System

Interventions

Position and Angle Marking System DEVICE

Position and Angular Marking System (PAMS) attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.

Also known as: PAMS

Position and Angle Marking System (PAMS)

Standard clinical practice DEVICE

When the desired insertion site is identified by ultrasound, the doctor demarcate the needle insertion point using marker pens.

Standard clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anaesthesiologists
• Trained in the use of ultrasound-guided neuraxial procedures

You may not qualify if:

• No experience with ultrasound-guided neuraxial procedures
• Simulated patients
• Healthy, no significant medical comorbidity (American Society of Anesthesiologists Physical Status I or II)
• No spinal abnormalities, or previous spinal surgery
• Significant spinal abnormality
• Previous spinal surgery

Sponsors & Collaborators

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

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 128038, Singapore

RECRUITING

Related Publications (1)

• Tan HS, Sng BL, Sia ATH. Reducing breakthrough pain during labour epidural analgesia: an update. Curr Opin Anaesthesiol. 2019 Jun;32(3):307-314. doi: 10.1097/ACO.0000000000000713.

  PMID: 31045638 BACKGROUND

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Hon Sen Tan, MD

CONTACT

+65 63947107; paul.tan.hs@singhealth.com.sg

Ban Leong Sng, MBBS

CONTACT

+65 63941077; sng.ban.leong@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking involved.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Model Details: The ultrasound operators will be randomised to perform either 1. Skin marking after lumbar ultrasonography using marker pens (standard practice) 2. Skin marking after lumbar ultrasonography using PAMS After completion of the first procedure, the ultrasound operators will then crossover and perform the other procedure.

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 2, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)