Catheterization, PeripheralNCT06033677
Increasing Security With End-zone Arterial Blood Pressure Monitoring During Surgery
A study testing Distal radial artery cannulation and Forearm radial artery cannulation in people with Catheterization, Peripheral, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Short summary: The aim of this randomized controlled clinical research study was to compare distal radial artery cannulation with forearm radial artery cannulation in terms of efficacy and ease of administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- Distal radial artery cannulation and Forearm radial artery cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2024to 15 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for elective surgery
- Aged 18 and above
- ASA 1, 2, or 3 classifications
- Requiring intraoperative arterial cannulation
- At TC SBÜ Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in the study
Who cannot join
- Under 18 years of age
- ASA-4 classification
- Presence of non-palpable arteries
- Presence of burns or infection at the cannulation site
- Peripheral vascular disease, bleeding or coagulation disorders
- Negative modified Allen's test, and communication disorders. The withdrawal criteria for the study include a patient's desire to withdraw from the study at any stage and an extended cannulation time.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gazi Yaşargil Training and Research Hospital:
Diyarbakır, 21070
About this study
Official title: "Intraoperative Use of Distal Radial Artery Cannulation With Snuffbox Approach'
Short summary: The aim of this randomized controlled clinical research study was to compare distal radial artery cannulation with forearm radial artery cannulation in terms of efficacy and ease of administration. The investigators believe that cannulation of the distal radial artery in cases requiring invasive arterial monitoring should preserve the radial artery of the forearm for future health problems and reduce circulatory complications by working more distally.
The main question[s] aims to answer are:
- [question 1]: whether artery monitoring can be performed with a more distal approach
- [question 2]: efficacy and safety of the distal approach
Read the detailed description
The distal radial artery (dRA) in the snuffbox location is a popular arterial access site for interventional cardiological procedures and neurointerventions. The investigators aimed to investigate the distal radial artery as an alternative site to the classical radial artery (RA) in cases requiring intraoperative arterial cannulation and blood pressure monitoring. The superficial location of the classic radial artery, its collateral blood flow with the ulnar artery, and limited complications make it a preferred choice for catheterization purposes. Given its use in various medical procedures such as flap transplantation, creating arteriovenous fistulas for hemodialysis, and bypass grafting, the investigators believe that preserving the classic radial artery is essential for potential health issues likely to arise in the future. In addition, the investigators aim to minimize circulatory complications by working more distally. Furthermore, it's worth mentioning that alterations in wrist positioning causing disruptions in the invasive arterial waveform also create a need for a different puncture approach. For all these conditions, the investigators believe that the snuffbox approach to distal radial artery cannulation would be an advantageous alternative.
This study will be a prospective randomized, controlled single-blind study. Patients who are scheduled for elective surgery, aged 18 and above, with ASA 1, 2, or 3 classifications, and requiring intraoperative arterial cannulation at Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in the study. The exclusion criteria for participating in the study are as follows: under 18 years of age, ASA-4 classification, presence of non-palpable arteries, presence of burns or infection at the cannulation site, peripheral vascular disease, bleeding or coagulation disorders, negative modified Allen's test, and communication disorders. The withdrawal criteria for the study include a patient's desire to withdraw from the study at any stage and an extended cannulation time.
Participants will be divided into two groups, and ultrasound-guided cannulation will be performed for each group. One group will be cannulated through the classical radial artery of the forearm, while the other group will be cannulated through the distal radial artery using the snuffbox approach. Demographic data (age, gender, weight, height, BMI, comorbidity, medications, ASA, previous artery intervention, working position and working time), USG measurement data (diameter and depth of the artery) and procedural data (hand selection, first attempt success rate, arterial catheterization time, arterial posterior wall puncture rate, intraoperative artery waveform quality, postoperative compression time, and complications) will be recorded.
The sample size was determined by G-Power version 3.1.9.4, taking into account a two-tailed alpha error of 0.05, a power of 0.80, and an effect size of 0.5. Based on this savings and N2/N1 allocations of 0.98 in a previous study ( Distal radial artery as an alternative approach to forearm radial artery for perioperative blood pressure monitoring: a randomized, controlled, noninferiority trial Jingwei Xiong1 , Kangli Hui1 , Miaomiao Xu1 , Jiejie Zhou1 , Jie Zhang1 and Manlin Duan1,2* Xiong et al. BMC Anesthesiology (2022) 22:67 https://doi.org/10.1186/s12871-022-01609-5 ), the minimum number required for the study was planned to be 52 patients in the dRA group and 50 patients in the RA group.
The intervention will be performed under USG guidance by a single anesthesiologist with at least 5 years of experience in arterial cannulation.
The anticipated study duration is 6 months, and once approved by your institution, the study will commence and will be concluded upon reaching the target number of participants.
SPSS 21.0 for Windows software (SPSS Inc., Chicago, IL, USA) will be conducted for statistical analysis of the data. When evaluating the data statistically, numerical data will be expressed as mean and standard deviation, while categorical data will be presented as frequency and percentage. The chi-square test and Fisher's Exact test will be used to compare categorical data between groups, and the results will be reported as percentages (%n). Non-categorical data's normal distribution will be assessed using the Kolmogorov-Smirnov test. For normally distributed data, Student's t-test was used for statistical comparison between groups. For non-normally distributed data, the Mann-Whitney U test was employed. In all analyses, p-values less than 0.05 will be considered statistically significant.
- Conditions
- Catheterization, Peripheral
- Being tested
- Distal radial artery cannulation, Forearm radial artery cannulation
- Keywords
- Invasive arterial pressure monitoring, Distal radial artery cannulation, Fovea radialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial artery cannulationProcedure or surgery
Interventional application for invasive blood pressure monitoring
Forearm radial artery cannulationProcedure or surgery
Interventional application for invasive blood pressure monitoring
| Study group | Role | What they receive |
|---|---|---|
| Grup 1-Forearm radial artery cannulation (FRA) | Other | The patients who were to undergo forearm radial artery catheterization were positioned with wrist dorsifection up to 30° and forearm supination. Intervention was planned after ultrasonographic measurements were taken. Receives: Procedure: Forearm radial artery cannulation |
| Grup 2-Distal radial artery cannulation (DRA) | Active comparator | The patients who will undergo distal radial artery catheterization were placed in the pronation position of the forearm with the anatomical snuffbox facing upwards. Intervention was planned after ultrasonographic measurements were taken. Receives: Procedure: Distal radial artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interventions performed with USG guidance
The number of attempts will be recorded as 1st attempt, 2nd attempt and 3rd and above attempts.
Measured: during cannulation procedure
Secondary outcomes (4)
arterial catheterization time
Arterial catheterization time will be evaluated as under or over 3 minutes.
Measured: during cannulation procedure
Monitored arterial waveform success
Monitored arterial waveform success will be evaluated as follows
- successful (there is a wave)
- fail (no wave)
- intraoperative damping time (the time during which the arterial wave disappears while the operation continues)
Measured: During the intraoperative period
Compression time after catheter removal
After the catheter is removed, the compression time will be measured in seconds. Bleeding will be checked every 30 seconds.
Measured: procedure (the process until the catheter is removed and the bleeding stops)
complication follow-up
Developing complications (vasospasm, hematoma, color and temperature change in the finger)
- During the intraoperative period,
- In the postoperative period
- upon first arrival in the recovery room,
- 1st hour at the end of the operation,
- 6th hour at the end of the operation and
- 24st at the end of the operation] will be recorded.
Measured: Complication follow-up will be done from the beginning of cannulation procedure to the 24th hour postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start17 Jan 2024
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients scheduled for elective surgery and requiring invasive arterial monitoring were divided into two groups. Group 1: The patients who were to undergo forearm radial artery catheterization were positioned with wrist dorsifection up to 30° and forearm supination. Intervention was planned after ultrasonographic measurements were taken. Group 2: The patients who will undergo distal radial artery catheterization were placed in the pronation position of the forearm with the anatomical snuffbox facing upwards. Intervention was planned after ultrasonographic measurements were taken.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Erdal Erbatur, MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Meral Edal Erbatur, M.D., Principal investigator, University of Health Sciences Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033677
- Sponsor's protocol ID
- 114-24/06/2022
- Status last verified
- Jun 2024
- First submitted
- 22 Aug 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamandi M, Saad M, Hasan R, Megaly M, Abbott JD, Dib C, Szerlip M, Potluri S, Lotfi A, Kiemeneij F, Al-Azizi KM. Distal Versus Conventional Transradial Artery Access for Coronary Angiography and Intervention: A Meta-Analysis. Cardiovasc Revasc Med. 2020 Oct;21(10):1209-1213. doi: 10.1016/j.carrev.2020.03.020. Epub 2020 Mar 14.
PubMed 32321695Hammami R, Zouari F, Ben Abdessalem MA, Sassi A, Ellouze T, Bahloul A, Mallek S, Triki F, Mahdhaoui A, Jeridi G, Abid L, Charfeddine S, Kammoun S, Jdidi J. Distal radial approach versus conventional radial approach: a comparative study of feasibility and safety. Libyan J Med. 2021 Dec;16(1):1830600. doi: 10.1080/19932820.2020.1830600.
PubMed 33147107
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Intraoperative Use of Distal Radial Artery Cannulation With Snuffbox Approach'
- ClinicalTrials.gov ID
- NCT06033677
- Acronym / sponsor ID
- 114-24/06/2022
- Conditions
- Catheterization, Peripheral
- Keywords
- Invasive arterial pressure monitoring, Distal radial artery cannulation, Fovea radialis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 13 Sep 2023 (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.
Short summary: The aim of this randomized controlled clinical research study was to compare distal radial artery cannulation with forearm radial artery cannulation in terms of efficacy and ease of administration. The investigators believe that cannulation of the distal radial artery in cases requiring invasive arterial monitoring should preserve the radial artery of the forearm for future health problems and reduce circulatory complications by working more distally.
The main question[s] aims to answer are:
- [question 1]: whether artery monitoring can be performed with a more distal approach
- [question 2]: efficacy and safety of the distal approach
Detailed description
The distal radial artery (dRA) in the snuffbox location is a popular arterial access site for interventional cardiological procedures and neurointerventions. The investigators aimed to investigate the distal radial artery as an alternative site to the classical radial artery (RA) in cases requiring intraoperative arterial cannulation and blood pressure monitoring. The superficial location of the classic radial artery, its collateral blood flow with the ulnar artery, and limited complications make it a preferred choice for catheterization purposes. Given its use in various medical procedures such as flap transplantation, creating arteriovenous fistulas for hemodialysis, and bypass grafting, the investigators believe that preserving the classic radial artery is essential for potential health issues likely to arise in the future. In addition, the investigators aim to minimize circulatory complications by working more distally. Furthermore, it's worth mentioning that alterations in wrist positioning causing disruptions in the invasive arterial waveform also create a need for a different puncture approach. For all these conditions, the investigators believe that the snuffbox approach to distal radial artery cannulation would be an advantageous alternative.
This study will be a prospective randomized, controlled single-blind study. Patients who are scheduled for elective surgery, aged 18 and above, with ASA 1, 2, or 3 classifications, and requiring intraoperative arterial cannulation at Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in the study. The exclusion criteria for participating in the study are as follows: under 18 years of age, ASA-4 classification, presence of non-palpable arteries, presence of burns or infection at the cannulation site, peripheral vascular disease, bleeding or coagulation disorders, negative modified Allen's test, and communication disorders. The withdrawal criteria for the study include a patient's desire to withdraw from the study at any stage and an extended cannulation time.
Participants will be divided into two groups, and ultrasound-guided cannulation will be performed for each group. One group will be cannulated through the classical radial artery of the forearm, while the other group will be cannulated through the distal radial artery using the snuffbox approach. Demographic data (age, gender, weight, height, BMI, comorbidity, medications, ASA, previous artery intervention, working position and working time), USG measurement data (diameter and depth of the artery) and procedural data (hand selection, first attempt success rate, arterial catheterization time, arterial posterior wall puncture rate, intraoperative artery waveform quality, postoperative compression time, and complications) will be recorded.
The sample size was determined by G-Power version 3.1.9.4, taking into account a two-tailed alpha error of 0.05, a power of 0.80, and an effect size of 0.5. Based on this savings and N2/N1 allocations of 0.98 in a previous study ( Distal radial artery as an alternative approach to forearm radial artery for perioperative blood pressure monitoring: a randomized, controlled, noninferiority trial Jingwei Xiong1 , Kangli Hui1 , Miaomiao Xu1 , Jiejie Zhou1 , Jie Zhang1 and Manlin Duan1,2* Xiong et al. BMC Anesthesiology (2022) 22:67 https://doi.org/10.1186/s12871-022-01609-5 ), the minimum number required for the study was planned to be 52 patients in the dRA group and 50 patients in the RA group.
The intervention will be performed under USG guidance by a single anesthesiologist with at least 5 years of experience in arterial cannulation.
The anticipated study duration is 6 months, and once approved by your institution, the study will commence and will be concluded upon reaching the target number of participants.
SPSS 21.0 for Windows software (SPSS Inc., Chicago, IL, USA) will be conducted for statistical analysis of the data. When evaluating the data statistically, numerical data will be expressed as mean and standard deviation, while categorical data will be presented as frequency and percentage. The chi-square test and Fisher's Exact test will be used to compare categorical data between groups, and the results will be reported as percentages (%n). Non-categorical data's normal distribution will be assessed using the Kolmogorov-Smirnov test. For normally distributed data, Student's t-test was used for statistical comparison between groups. For non-normally distributed data, the Mann-Whitney U test was employed. In all analyses, p-values less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients scheduled for elective surgery and requiring invasive arterial monitoring were divided into two groups. Group 1: The patients who were to undergo forearm radial artery catheterization were positioned with wrist dorsifection up to 30° and forearm supination. Intervention was planned after ultrasonographic measurements were taken. Group 2: The patients who will undergo distal radial artery catheterization were placed in the pronation position of the forearm with the anatomical snuffbox facing upwards. Intervention was planned after ultrasonographic measurements were taken.
| Arm | Type | Receives |
|---|---|---|
| Grup 1-Forearm radial artery cannulation (FRA) | Other | Procedure: Forearm radial artery cannulationThe patients who were to undergo forearm radial artery catheterization were positioned with wrist dorsifection up to 30° and forearm supination. Intervention was planned after ultrasonographic measurements were taken. |
| Grup 2-Distal radial artery cannulation (DRA) | Active comparator | Procedure: Distal radial artery cannulationThe patients who will undergo distal radial artery catheterization were placed in the pronation position of the forearm with the anatomical snuffbox facing upwards. Intervention was planned after ultrasonographic measurements were taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are scheduled for elective surgery
- Aged 18 and above
- ASA 1, 2, or 3 classifications
- Requiring intraoperative arterial cannulation
- At TC SBÜ Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in the study
Key exclusion criteria (6 listed)
- Under 18 years of age
- ASA-4 classification
- Presence of non-palpable arteries
- Presence of burns or infection at the cannulation site
- Peripheral vascular disease, bleeding or coagulation disorders
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 |
|---|---|---|
| Distal radial artery cannulationInterventional application for invasive blood pressure monitoring | Procedure or surgery | Grup 2-Distal radial artery cannulation (DRA) |
| Forearm radial artery cannulationInterventional application for invasive blood pressure monitoring | Procedure or surgery | Grup 1-Forearm radial artery cannulation (FRA) |
Primary outcome
Number of interventions performed with USG guidance
Time frame: during cannulation procedure
The number of attempts will be recorded as 1st attempt, 2nd attempt and 3rd and above attempts.
4 secondary outcomes
arterial catheterization time
Time frame: during cannulation procedure
Monitored arterial waveform success
Time frame: During the intraoperative period
Compression time after catheter removal
Time frame: procedure (the process until the catheter is removed and the bleeding stops)
complication follow-up
Time frame: Complication follow-up will be done from the beginning of cannulation procedure to the 24th hour postoperatively.
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 13 Jun 2024.
- Background: PubMed 32321695Hamandi M, Saad M, Hasan R, Megaly M, Abbott JD, Dib C, Szerlip M, Potluri S, Lotfi A, Kiemeneij F, Al-Azizi KM. Distal Versus Conventional Transradial Artery Access for Coronary Angiography and Intervention: A Meta-Analysis. Cardiovasc Revasc Med. 2020 Oct;21(10):1209-1213. doi: 10.1016/j.carrev.2020.03.020. Epub 2020 Mar 14.
- Results publication: PubMed 33147107Hammami R, Zouari F, Ben Abdessalem MA, Sassi A, Ellouze T, Bahloul A, Mallek S, Triki F, Mahdhaoui A, Jeridi G, Abid L, Charfeddine S, Kammoun S, Jdidi J. Distal radial approach versus conventional radial approach: a comparative study of feasibility and safety. Libyan J Med. 2021 Dec;16(1):1830600. doi: 10.1080/19932820.2020.1830600.
- Individual participant dataSharing planned: No
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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.
Meral Edal Erbatur, M.D. principal investigator
University of Health Sciences Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal radial artery cannulation and Forearm radial artery cannulation in people with Catheterization, Peripheral, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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 5 inclusion and 6 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 13 Jun 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?
Number of interventions performed with USG guidance (time frame: during cannulation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033677, which also lists 2 linked publications.
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 13 Jun 2024.