CatheterizationNCT06271499
The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization
A study testing Radial artery catheterization with USG and Radial artery catheterization with smart glasses integrated UGG in people with Catheterization and Cannulation, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Catheterization, Cannulation
- What is being tested?
- Radial artery catheterization with USG and Radial artery catheterization with smart glasses integrated UGG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years who would have undergone elective elective surgery with an indication for radial artery catheterization between August 2022 and December 2022
Who cannot join
- Patients who underwent radial artery catheterization for any reason in the last 1 month and with contraindications for catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Catheterization, Cannulation
- Being tested
- Radial artery catheterization with USG, Radial artery catheterization with smart glasses integrated UGG
- Keywords
- Radial artery cannulation, Ultrasonography, Smart glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial artery catheterization with USGOther
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.
Radial artery catheterization with smart glasses integrated UGGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients underwent radial artery catheterization using standard USG Receives: Other: Radial artery catheterization with USG |
| Group II | Active comparator | Patients underwent radial artery catheterization using smart glasses integrated UGG Receives: Other: Radial artery catheterization with smart glasses integrated UGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate
After the catheterization, when the artery waveform was on monitor, the catheterization was considered successful.
Measured: 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).
Measured: At the end of the radial artery catheterization
Secondary outcomes (2)
The cannulation time
The time between puncture and the seen of artery waveform seen was recorded as cannulation time
Measured: At the end of the radial artery catheterization
Complications
After catheterization, the radial artery was re-imaged with USG in terms of complications.
Measured: At the end of the radial artery catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Aug 2022
- Primary completion28 Dec 2022
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Ayşegül Güven, Bengi Safak, Ahmet Onat Bermede
- Responsible party
- Principal investigator, Merve Gozen, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271499
- Sponsor's protocol ID
- AnkaraU-Smart-cannulation
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Smart Glasses Integrated Ultrasonography on the Success of the Procedure and Comfort of the Anesthesiologist in Radial Artery Catheterization
- ClinicalTrials.gov ID
- NCT06271499
- Acronym / sponsor ID
- AnkaraU-Smart-cannulation
- Conditions
- Catheterization, Cannulation
- Keywords
- Radial artery cannulation, Ultrasonography, Smart glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Ayşegül Güven, Bengi Safak, Ahmet Onat Bermede
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: Radial artery catheterization with USGPatients underwent radial artery catheterization using standard USG |
| Group II | Active comparator | Other: Radial artery catheterization with smart glasses integrated UGGPatients underwent radial artery catheterization using smart glasses integrated UGG |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years who would have undergone elective elective surgery with an indication for radial artery catheterization between August 2022 and December 2022
Key exclusion criteria (1 listed)
- Patients who underwent radial artery catheterization for any reason in the last 1 month and with contraindications for catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial artery catheterization with USGRadial 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. | Other | Group I |
| Radial artery catheterization with smart glasses integrated UGGThe 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. | Other | Group II |
Primary outcome
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.
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).
2 secondary outcomes
The cannulation time
Time frame: At the end of the radial artery catheterization
Complications
Time frame: At the end of the radial artery catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Catheterization
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Novel Wearable Device for Heart Failure Management
Heart Failure
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial artery catheterization with USG and Radial artery catheterization with smart glasses integrated UGG in people with Catheterization and Cannulation, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate (time frame: At the end of the radial artery catheterization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.