Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04028284 |
| Other study ID # |
Hololens |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2019 |
| Est. completion date |
February 19, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
US guidance for epidural anesthesia is yet challenging due to anatomical and technical
restrictions which are rely on the operator's memory to imitate accurate needle trajectory.
To address the problem, the study investigators designed and developed the first model of a
live anatomical holographic marking system using Microsoft HoloLens, an augmented reality
technology tool, to provide a superimposed US image as an objective alternative to the
operator's memory. In this study, the proposed methodology will be used to accurate and ease
directing the needle insertion thereby leading to the success of the epidural placement and
decrease in procedure time. Based on previously published and data from the SHSC institution,
mean thoracic epidural analgesia placement required 10 minutes with a standard deviation of 3
minutes. A reduction in procedure time will reduce patient discomfort, increase block and
operating rooms efficiency thereby reducing hospital costs as well as used for anatomically
challenging patients.
The investigators hypothesize that using augmented reality through HoloLens will lead to
implementation of a newly developed virtual holographic 'see-through' tool for neuraxial
anesthetic techniques that will increase needle accuracy and decrease procedure time.
The main question of the study is to assess the accuracy of the developed application. In
particular, the study will determine if a holographic marking of the site of needle insertion
and optimal angulation will increase needle accuracy and reduce procedure time by increasing
first past success when compared to traditional ultrasound land-mark based techniques.
The methodology proposed in this study is truly innovative in medical content, involves a
partnership with software and engineering experts. The study will lead to implementation of a
new objective tool, validation of which will create an accessible, cost-effective piece of
technology that will reduce patient morbidity and increase procedure success rate. This
'state-of-the-art' technology can be used for alternate procedures such as peripheral nerve
block in patients that cannot be easily positioned for live US techniques. Also, this study
will generate a knowledge-based approach that can be used as a teaching and clinical tool
locally at institutions presented with anatomically difficult population (e.g. trauma,
obstetric patients) at Sunnybrook Health Sciences Centre and around the world, where
resources are at a minimum.
This is a prospective cohort randomized trial. With institutional ethical approval and having
obtained both, written informed consent and verbal assent from participants, 84 thoracic
epidural events will be assessed. A thoracic spine US 3D Phantom model utilizing open source
BodyParts3D library anatomy files constructed by group of software and engineering experts,
and accessible for practice to anesthetists. Our 3D Phantom model has similar palpation
characteristics to a patient mimicking a standard loss of resistance to saline that occurs on
entrance of a needle to the spinal canal cavity. The holographic mapping methodology will be
practiced by anesthetists on the Phantom model until they feel comfortable with the system
prior the study start. Participants will be recruited from the pre-anesthesia clinic. Only
participants who meet inclusion criteria will be approached for participation in this study
(Table 1,inclusion/exclusion criteria, study protocol). The anesthetists will be randomized
to: Group1, landmark based thoracic epidural technique(control) or, Group 2,
HoloLens-assisted thoracic epidural technique(intervention), where the needle will be
inserted using instantly created holographic trajectory. SHS centre has a dedicated regional
block room and four regional expert anesthetists in the US-guided thoracic epidural technique
and are comfortable with the HoloLens. Prior to the study start, anesthetists will practice
needle insertion on the phantom model by attempting needle insertion 20Xeach, or until they
felt comfortable with the tool, while wearing HoloLens. Other aspects of patient care will
follow the standard of care at the centre. Data will be collected by anesthetists and include
patients surgical/abdominal pain assessment during epidural procedure and post-operatively,
and questionnaire about their experience using the HoloLens.
Data will be validated to enable optimization and further implementation of novel technology.
1. Inclusion Criteria/Anesthetists:
- Trained in US-guided epidural technique with fellowship
- Performed >100 thoracic US-guided epidural procedures
2. Exclusion Criteria/Patients:
- age >18
- Lack of verbal patient assent after study introduction
The control group will be required to determine if hologram mapping and methodology indeed
provide an accuracy of the holographic trajectory and create a live road map for the needle
path hidden under the patient's skin. Study paricipants will be withdrawn from the study at
their request at any time.
To address this study specific objectives of whether the HoloLens application, that is
designed to allow a holographic marking of the needle insertion site and optimal angulation
would 1) decrease procedure time by increasing first past success when used as a guide to the
thoracic epidural space; and 2) increase needle accuracy when compared to traditional
ultrasound landmark based techniques, an observer (i.e. anesthesiologist) will document
following:
1. the time to procedure completion starting from skin puncture to time at which the Tuohy
needle is withdrawn;
2. the number of a needle movements (in any direction/re-direction)
3. number of skin punctures made;
4. patients' pain score during the procedure and post-operatively using the numeric rating
scale (NRS);
5. any complications during the procedure such as paresthesias, dural punctures;
6. the need for patient controlled analgesia (PCA) in PACU (constituting failure of
epidural).
