N/A
N=83
HoloLens: an Objective Alternative to the Operator's Memory
Virtual Reality · Anesthesia · Epidural
Bottom Line
View on ClinicalTrials.gov: NCT04028284 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Procedure Time — 7.3; 4.5 Minutes — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HoloLens-guided epidural (Device); US-guided epidural (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sunnybrook Health Sciences Centre
- Primary completion
- Feb 2021
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 | — |
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.
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
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.