- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271499
The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization
The Effect of Using Smart Glasses Integrated Ultrasonography on the Success of the Procedure and Comfort of the Anesthesiologist in Radial Artery Catheterization
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Ankara University Medical Faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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Active Comparator: Group II
Patients underwent radial artery catheterization using smart glasses integrated UGG
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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.
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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
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After the catheterization, when the artery waveform was on monitor, the catheterization was considered successful.
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At the end of the radial artery catheterization
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The anesthesiologist's satisfaction
Time Frame: At the end of the radial artery catheterization
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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).
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At the end of the radial artery catheterization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The cannulation time
Time Frame: At the end of the radial artery catheterization
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The time between puncture and the seen of artery waveform seen was recorded as cannulation time
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At the end of the radial artery catheterization
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Complications
Time Frame: At the end of the radial artery catheterization
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After catheterization, the radial artery was re-imaged with USG in terms of complications.
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At the end of the radial artery catheterization
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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