CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
HoloLens-guided epidural +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04028284
NCT04028284N/ACompleted

Using Augmented Reality to 3D Map Needle Pathways in Real Time to Enhance Neuraxial Anesthesia

Sunnybrook Health Sciences Centre·interventional·Posted Jul 22, 2019·Updated Jan 3, 2025

In Brief

A clinical study evaluating HoloLens-guided epidural and US-guided epidural for Virtual Reality and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 22, 2019
Enrollment StartJan 18, 2019
Primary CompletionFeb 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago

Interventions

HoloLens-guided epiduraldevice

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

US-guided epiduralother

traditional thoracic epidural procedure