Trial Outcomes & Findings for HoloLens: an Objective Alternative to the Operator's Memory (NCT NCT04028284)

NCT ID: NCT04028284

Last Updated: 2025-01-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: During procedure
• Results posted on: 2025-01-03

Participant Flow

1 participant was not randomized due to their surgery being cancelled.

Participant milestones

Measure	Group C In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Overall Study STARTED	42	41
Overall Study COMPLETED	42	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.	Total n=83 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 14.2 • n=42 Participants	62.9 years STANDARD_DEVIATION 13.3 • n=41 Participants	64.3 years STANDARD_DEVIATION 13.7 • n=83 Participants
Sex: Female, Male Female	20 Participants n=42 Participants	19 Participants n=41 Participants	39 Participants n=83 Participants
Sex: Female, Male Male	22 Participants n=42 Participants	22 Participants n=41 Participants	44 Participants n=83 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Surgical Type General	3 Participants n=42 Participants	3 Participants n=41 Participants	6 Participants n=83 Participants
Surgical Type Gynecologic	10 Participants n=42 Participants	13 Participants n=41 Participants	23 Participants n=83 Participants
Surgical Type Oncology	25 Participants n=42 Participants	24 Participants n=41 Participants	49 Participants n=83 Participants
Surgical Type Urologic	4 Participants n=42 Participants	1 Participants n=41 Participants	5 Participants n=83 Participants

PRIMARY outcome

Timeframe: During procedure

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

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Procedure Time	7.3 Minutes Standard Deviation 6.0	4.5 Minutes Standard Deviation 4.6

SECONDARY outcome

Timeframe: During procedure

The number of times the needle was completely withdrawn from the skin and reinserted at a new location.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Number of Needle Insertions	1.5 Insertions Standard Deviation 1.0	1.3 Insertions Standard Deviation 0.5

SECONDARY outcome

Timeframe: During procedure

Any advancement of of the needle along an unchanged trajectory.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Number of Needle Passes	14.4 Number of passes Standard Deviation 16.3	7.2 Number of passes Standard Deviation 7.9

SECONDARY outcome

Timeframe: During procedure

The number of times the needle contacted a bone, as reported by the anesthesiologist performing the procedure.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Number of Bone Contacts	12.2 Number of contacts Standard Deviation 16	6 Number of contacts Standard Deviation 8.0

SECONDARY outcome

Timeframe: During procedure

Procedural pain assessed using the numerical rating scale (0-10, with 0 indicating no pain and 10 the worst possible pain) after the completion of the epidural procedure.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Procedural Pain	2.6 Units on a scale Standard Deviation 1.6	2.8 Units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: In the PACU

Pain assessed using the numerical rating scale (0-10, with 0 indicating no pain and 10 the worst possible pain) in the post-anesthesia care unit.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Pain in PACU	2.6 Units on a scale Standard Deviation 3.0	2.4 Units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: In the PACU

Defined as unexpected addition of intravenous patient controlled analgesia to the patient's pain control regimen prior to discharge from the recovery room.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Number of Participants With Epidural Failure	3 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure

Complications such as paresthesia and dural puncture as noted by the observer.

Outcome measures

Measure	Group C n=42 Participants In Group C (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. US-guided epidural: traditional thoracic epidural procedure	Group H n=41 Participants In Group H (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described for Group C. 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. HoloLens-guided epidural: To determine whether using the HoloLens tool increases the success of epidural insertion.
Complications	0 Number of complications	0 Number of complications

Adverse Events

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group H

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fahad Alam

Sunnybrook Health Sciences Centre

Phone: 416-480-4864

Email: fahad.alam@sunnybrook.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place