ClinicalTrials.Veeva

Menu

Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks

A

Abant Izzet Baysal University

Status

Enrolling

Conditions

Nerve Block

Treatments

Device: Ultrasound guided smart glasses assisted
Device: Ultrasound guided

Study type

Interventional

Funder types

Other

Identifiers

NCT05409807
AIBU-TF-AR-II-002

Details and patient eligibility

About

This study hypothesizes that the use of smart glasses (Head-mounted display Vufine, model VUF-110, Vufine Inc., China)) improves the hand-eye coordination and the first-attempt success rate of ultrasound guided interscalene nerve block. This is a single-center, randomized, controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the interscalene block.

Full description

Peripheral nerve blocks, which help patients to recover early after surgery, are performed safely and successfully under ultrasound guidance. Ultrasound-guided peripheral nerve blocks provide sufficient anesthesia for the operation alone or can be applied in combination with general anesthesia and provide postoperative analgesia.

Investigators encounter new developments in health technologies almost every day. With the development of smart technologies and the spread of wearable devices, their use in the field of health is increasing day by day.

Hand-eye coordination is an important skill, especially in the use of ultrasound. The inserted needle should be followed during the procedure in the appropriate area and safely delivered to the desired area.

Patients will be divided into either the study group or the control group. Interscalene nerve block will be performed with preoperative sedation, ultrasound guidance and nerve stimulator.

Interscalene nerve block will be applied to the patients in the study group by using the smart glasses screen, and to the patients in the control group with the conventional ultrasound screen.

In this clinical study, the first trial success rate of the procedures, the time spent during the procedure, the overall success rate, the ergonomics of the practitioner, and the complications related to the block will be recorded and compared.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who are planned to undergo surgery under general anesthesia
  • Patients scheduled for postoperative analgesia after shoulder surgery

Exclusion criteria

  • Local anesthetic allergy
  • Skin disease, infection, hematoma
  • Chronic obstructive pulmonary disease
  • Hepatic, renal, cardiac failures
  • Pregnancy
  • Uncooperative patient

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Classic Ultrasound Guided
Experimental group
Description:
Ultrasound guided interscalene nerve block
Treatment:
Device: Ultrasound guided
Smart Glasses Assisted
Experimental group
Description:
Ultrasound guided smart glasses assisted interscalene nerve block
Treatment:
Device: Ultrasound guided smart glasses assisted

Trial contacts and locations

1

Loading...

Central trial contact

Ilker Ital, MD; Tacettin Ayanoglu, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems