The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization

February 14, 2024 updated by: Merve Gozen, Ankara University

The Effect of Using Smart Glasses Integrated Ultrasonography on the Success of the Procedure and Comfort of the Anesthesiologist in Radial Artery Catheterization

The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG.

Study Overview

Detailed Description

The arterial catheterizations were usually performed by anesthesiologists in operation rooms and intensive care units for many reasons such as blood pressure monitoring and gas sampling. The choice of radial artery is because of its anatomic advantages. However some patients related features can cause difficulties in catheterization. The use of ultrasounography (USG) guidance raises the rate of success and decreases the complications. Coordination skills between hand, eye, procedure area and screen are essential for the USG-guided catheterization. Smarth glasses, project the USG image in real-time directly in front of the practitioner's eyes and thus allows the practitioner to simultaneously view the screen and the procedure area. The primer aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG. The secondary aims are to evaluate the cannulation time and complications between groups.

120 patients >18 years who would be undergone elective elective surgery with an indication for radial artery catheterization between August 2022 and December 2022 were included to the prospective, randomised, single centre study. Patients underwent radial artery catheterization for any reason in the last one month, and with contraindications for catheterization were excluded. Patients were divided randomly into two groups (Group I: patients underwent radial artery catheterization using standart USG, and Group II: patients underwent radial artery catheterization using smart glasses integrated UGG). The catheterization was performed by two anesthetists with different experience. The subcutaneous distance, radial artery depth and diameter in short axis, cannulation time and ergonomic satisfaction of the practitioners were recorded. The program SPSS 11.5 was used to analyze data.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Ankara University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years who would have undergone elective elective surgery with an indication for radial artery catheterization between August 2022 and December 2022

Exclusion Criteria:

  • Patients who underwent radial artery catheterization for any reason in the last 1 month and with contraindications for catheterization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Patients underwent radial artery catheterization using standard USG
Radial artery catheterization with USG The catheterization was performed by two anesthesiologist with different experience (Junior practitoner who has the experience of 20-50, and the senior practitioner who has the experience of >50 radial artery catheterizations). The side to be catheterized was determined by modifie Allen test which was first performed on the nondominant hand. After general anesthesia induction, a 45° angle was given to wirst of selected side with a support. After skin asepsis, radial artery was vizualized 2 centimeter (cm) above the wrist in short axis with the high-frequency linear USG probe. The radial artery puncture was performed while step by step monitoring the needle tip in short axis out-of-plane technique. Following the puncture, radial artery catheterized with a 3 French 8 cm catheter.
Active Comparator: Group II
Patients underwent radial artery catheterization using smart glasses integrated UGG
The catheterization was performed by two anesthesiologist with different experience (Junior practitoner who has the experience of 20-50, and the senior practitioner who has the experience of >50 radial artery catheterizations). Before the study, as practitioners had no previous experience with smart glasses, they performed 5 catheterizations with smart glasses integrated USG on model. The side to be catheterized was determined by modifie Allen test which was first performed on the nondominant hand. After general anesthesia induction, a 45° angle was given to wirst of selected side with a support. After skin asepsis, radial artery was vizualized 2 centimeter (cm) above the wrist in short axis with smart glasses integrated high-frequency linear USG probe. The radial artery puncture was performed while step by step monitoring the needle tip in short axis out-of-plane technique. Following the puncture, radial artery catheterized with a 3 French 8 cm catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate
Time Frame: At the end of the radial artery catheterization
After the catheterization, when the artery waveform was on monitor, the catheterization was considered successful.
At the end of the radial artery catheterization
The anesthesiologist's satisfaction
Time Frame: At the end of the radial artery catheterization
The ergonomic satisfaction of the practitioner was evaluated on a 5-point Likert scale (1: Very dissatisfied, 2: Dissatisfied, 3: Undecided, 4: Satisfied, 5: Very satisfied).
At the end of the radial artery catheterization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cannulation time
Time Frame: At the end of the radial artery catheterization
The time between puncture and the seen of artery waveform seen was recorded as cannulation time
At the end of the radial artery catheterization
Complications
Time Frame: At the end of the radial artery catheterization
After catheterization, the radial artery was re-imaged with USG in terms of complications.
At the end of the radial artery catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 28, 2022

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • AnkaraU-Smart-cannulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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