HoloLens: an Objective Alternative to the Operator's Memory

NCT04028284 | Completed Results

• 1 other identifier: Hololens
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Neuraxial anesthesia has traditionally been a 'blind' technique relying on users' feel and skill, both are subjective, lack complete accuracy and influenced by patient's physique variations that are quite challenging, and lead to patient morbidity, infection, and nerve injury. The ultrasound(US) use allows real-time views of needle position thereby achieving higher success rates, fewer complications, and reduced patient discomfort. While US guidance for neuraxial procedures is popular, it is still relatively uncommon due to technical and anatomical challenges. The study investigators have created an innovative methodology to use with HoloLens, an augmented reality tool, to provide an accurate live road map for the needle path hidden under the patient's skin. This see-through model is an objective alternative to the user's memory for direct visualization of the needle virtual trajectory as it passed through the tissue and towards the 3D printed bone. Also, this model may have a variety uses in anesthesia.

Conditions

Virtual Reality; Anesthesia; Epidural

Keywords

epidural; analgesia; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Procedure Time

  The time starting from skin puncture until withdrawal of the Tuohy needle after successful catheter placement.

  During procedure

Secondary Outcomes (7)

• Number of Needle Insertions

  During procedure

• Number of Needle Passes

  During procedure

• Number of Bone Contacts

  During procedure

• Procedural Pain

  During procedure

• Pain in PACU

  In the PACU

Study Arms (2)

Group 1

ACTIVE COMPARATOR

In Group 1 (control), the staff anesthesiologist will follow the traditional technique for US-guided thoracic epidural insertion. Briefly, the anesthesiologist will use the US to identify and mark the appropriate spot for placement of the thoracic epidural catheter. The US probe is then placed at rest and the anesthesiologist will proceed with thoracic epidural needle insertion following standard techniques.

Other: US-guided epidural

Group 2

ACTIVE COMPARATOR

In Group 2 (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described above for Group 1. In combination with the US, a hologram image of the trajectory towards the epidural space will be generated, thereby mitigating the need to walk off the lamina. The holographic system will mark the appropriate spot for placement of the thoracic epidural catheter. Then, the needle will be inserted following the holographic trajectory overlaid on the patient's back.

Device: HoloLens-guided epidural

Interventions

HoloLens-guided epidural DEVICE

To determine whether using the HoloLens tool increases the success of epidural insertion.

Group 2

US-guided epidural OTHER

traditional thoracic epidural procedure

Group 1

Eligibility Criteria

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

You may qualify if:

• Trained in US-guided epidural technique with fellowship
• Performed \>100 thoracic US-guided epidural procedures

You may not qualify if:

• Age \<18
• Lack of verbal patient assent after study introduction

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Canada

Location

Related Publications (2)

• Wiegelmann J, Choi S, McHardy PG, Matava C, Singer O, Kaustov L, Alam F. Randomized control trial of a holographic needle guidance technique for thoracic epidural placement. Reg Anesth Pain Med. 2024 Dec 2;49(12):861-866. doi: 10.1136/rapm-2023-104703.

  PMID: 38212048 DERIVED

• Tanwani J, Alam F, Matava C, Choi S, McHardy P, Singer O, Cheong G, Wiegelmann J. Development of a Head-Mounted Holographic Needle Guidance System for Enhanced Ultrasound-Guided Neuraxial Anesthesia: System Development and Observational Evaluation. JMIR Form Res. 2022 Jun 23;6(6):e36931. doi: 10.2196/36931.

  PMID: 35737430 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Fahad Alam
• Organization: Sunnybrook Health Sciences Centre

fahad.alam@sunnybrook.ca

416-480-4864

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: July 22, 2019
• Study Start: January 18, 2019
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Locations

CA (1)