NCT06271499

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 14, 2024

Last Update Submit

February 14, 2024

Conditions

Keywords

Radial artery cannulationUltrasonographySmart glasses

Outcome Measures

Primary Outcomes (2)

  • The success rate

    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

    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 Outcomes (2)

  • The cannulation time

    At the end of the radial artery catheterization

  • Complications

    At the end of the radial artery catheterization

Study Arms (2)

Group I

ACTIVE COMPARATOR

Patients underwent radial artery catheterization using standard USG

Other: Radial artery catheterization with USG

Group II

ACTIVE COMPARATOR

Patients underwent radial artery catheterization using smart glasses integrated UGG

Other: Radial artery catheterization with smart glasses integrated UGG

Interventions

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.

Group I

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.

Group II

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, M.D.

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 21, 2024

Study Start

August 1, 2022

Primary Completion

December 28, 2022

Study Completion

February 14, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations