N/A Completed N=83 Randomized Device Feasibility

HoloLens: an Objective Alternative to the Operator's Memory

Virtual Reality · Anesthesia · Epidural

Source: ClinicalTrials.gov NCT04028284 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcomePrimary: Procedure Time — 7.3; 4.5 Minutes — p=0.02

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Procedure Time	7.3; 4.5	0.02 sig
SECONDARY Number of Needle Insertions	1.5; 1.3	0.31
SECONDARY Number of Needle Passes	14.4; 7.2	0.01 sig
SECONDARY Number of Bone Contacts	12.2; 6	0.03 sig
SECONDARY Procedural Pain	2.6; 2.8	0.56
SECONDARY Pain in PACU	2.6; 2.4	0.78
SECONDARY Number of Participants With Epidural Failure	3; 0	0.24
SECONDARY Complications	0; 0	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Age <18
Lack of verbal patient assent after study introduction

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Data sourced from ClinicalTrials.gov (NCT04028284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.