xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06033677</url>
    </required_header>
    <id_info>
      <org_study_id>114-24/06/2022</org_study_id>
      <nct_id>NCT06033677</nct_id>
    </id_info>
    <brief_title>Increasing Security With End-zone Arterial Blood Pressure Monitoring During Surgery</brief_title>
    <official_title>&quot;Intraoperative Use of Distal Radial Artery Cannulation With Snuffbox Approach'</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Short summary: The aim of this randomized controlled clinical research study was to compare&#xD;
        distal radial artery cannulation with forearm radial artery cannulation in terms of efficacy&#xD;
        and ease of administration. The investigators believe that cannulation of the distal radial&#xD;
        artery in cases requiring invasive arterial monitoring should preserve the radial artery of&#xD;
        the forearm for future health problems and reduce circulatory complications by working more&#xD;
        distally.&#xD;
  &#xD;
        The main question[s] aims to answer are:&#xD;
  &#xD;
          -  [question 1]: whether artery monitoring can be performed with a more distal approach&#xD;
  &#xD;
          -  [question 2]: efficacy and safety of the distal approach&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The distal radial artery (dRA) in the snuffbox location is a popular arterial access site for&#xD;
        interventional cardiological procedures and neurointerventions. The investigators aimed to&#xD;
        investigate the distal radial artery as an alternative site to the classical radial artery&#xD;
        (RA) in cases requiring intraoperative arterial cannulation and blood pressure monitoring.&#xD;
        The superficial location of the classic radial artery, its collateral blood flow with the&#xD;
        ulnar artery, and limited complications make it a preferred choice for catheterization&#xD;
        purposes. Given its use in various medical procedures such as flap transplantation, creating&#xD;
        arteriovenous fistulas for hemodialysis, and bypass grafting, the investigators believe that&#xD;
        preserving the classic radial artery is essential for potential health issues likely to arise&#xD;
        in the future. In addition, the investigators aim to minimize circulatory complications by&#xD;
        working more distally. Furthermore, it's worth mentioning that alterations in wrist&#xD;
        positioning causing disruptions in the invasive arterial waveform also create a need for a&#xD;
        different puncture approach. For all these conditions, the investigators believe that the&#xD;
        snuffbox approach to distal radial artery cannulation would be an advantageous alternative.&#xD;
  &#xD;
        This study will be a prospective randomized, controlled single-blind study. Patients who are&#xD;
        scheduled for elective surgery, aged 18 and above, with ASA 1, 2, or 3 classifications, and&#xD;
        requiring intraoperative arterial cannulation at Diyarbakır Gazi Yaşargil Training and&#xD;
        Research Hospital will be included in the study. The exclusion criteria for participating in&#xD;
        the study are as follows: under 18 years of age, ASA-4 classification, presence of&#xD;
        non-palpable arteries, presence of burns or infection at the cannulation site, peripheral&#xD;
        vascular disease, bleeding or coagulation disorders, negative modified Allen's test, and&#xD;
        communication disorders. The withdrawal criteria for the study include a patient's desire to&#xD;
        withdraw from the study at any stage and an extended cannulation time.&#xD;
  &#xD;
        Participants will be divided into two groups, and ultrasound-guided cannulation will be&#xD;
        performed for each group. One group will be cannulated through the classical radial artery of&#xD;
        the forearm, while the other group will be cannulated through the distal radial artery using&#xD;
        the snuffbox approach. Demographic data (age, gender, weight, height, BMI, comorbidity,&#xD;
        medications, ASA, previous artery intervention, working position and working time), USG&#xD;
        measurement data (diameter and depth of the artery) and procedural data (hand selection,&#xD;
        first attempt success rate, arterial catheterization time, arterial posterior wall puncture&#xD;
        rate, intraoperative artery waveform quality, postoperative compression time, and&#xD;
        complications) will be recorded.&#xD;
  &#xD;
        The sample size was determined by G-Power version 3.1.9.4, taking into account a two-tailed&#xD;
        alpha error of 0.05, a power of 0.80, and an effect size of 0.5. Based on this savings and&#xD;
        N2/N1 allocations of 0.98 in a previous study ( Distal radial artery as an alternative&#xD;
        approach to forearm radial artery for perioperative blood pressure monitoring: a randomized,&#xD;
        controlled, noninferiority trial Jingwei Xiong1 , Kangli Hui1 , Miaomiao Xu1 , Jiejie Zhou1 ,&#xD;
        Jie Zhang1 and Manlin Duan1,2* Xiong et al. BMC Anesthesiology (2022) 22:67&#xD;
        https://doi.org/10.1186/s12871-022-01609-5 ), the minimum number required for the study was&#xD;
        planned to be 52 patients in the dRA group and 50 patients in the RA group.&#xD;
  &#xD;
        The intervention will be performed under USG guidance by a single anesthesiologist with at&#xD;
        least 5 years of experience in arterial cannulation.&#xD;
  &#xD;
        The anticipated study duration is 6 months, and once approved by your institution, the study&#xD;
        will commence and will be concluded upon reaching the target number of participants.&#xD;
  &#xD;
        SPSS 21.0 for Windows software (SPSS Inc., Chicago, IL, USA) will be conducted for&#xD;
        statistical analysis of the data. When evaluating the data statistically, numerical data will&#xD;
        be expressed as mean and standard deviation, while categorical data will be presented as&#xD;
        frequency and percentage. The chi-square test and Fisher's Exact test will be used to compare&#xD;
        categorical data between groups, and the results will be reported as percentages (%n).&#xD;
        Non-categorical data's normal distribution will be assessed using the Kolmogorov-Smirnov&#xD;
        test. For normally distributed data, Student's t-test was used for statistical comparison&#xD;
        between groups. For non-normally distributed data, the Mann-Whitney U test was employed. In&#xD;
        all analyses, p-values less than 0.05 will be considered statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients scheduled for elective surgery and requiring invasive arterial monitoring were divided into two groups.&#xD;
  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.&#xD;
  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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of interventions performed with USG guidance</measure>
      <time_frame>during cannulation procedure</time_frame>
      <description>The number of attempts will be recorded as 1st attempt, 2nd attempt and 3rd and above attempts.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>arterial catheterization time</measure>
      <time_frame>during cannulation procedure</time_frame>
      <description>Arterial catheterization time will be evaluated as under or over 3 minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Monitored arterial waveform success</measure>
      <time_frame>During the intraoperative period</time_frame>
      <description>Monitored arterial waveform success will be evaluated as follows&#xD;
  successful (there is a wave)&#xD;
  fail (no wave)&#xD;
  intraoperative damping time (the time during which the arterial wave disappears while the operation continues)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compression time after catheter removal</measure>
      <time_frame>procedure (the process until the catheter is removed and the bleeding stops)</time_frame>
      <description>After the catheter is removed, the compression time will be measured in seconds. Bleeding will be checked every 30 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complication follow-up</measure>
      <time_frame>Complication follow-up will be done from the beginning of cannulation procedure to the 24th hour postoperatively.</time_frame>
      <description>Developing complications (vasospasm, hematoma, color and temperature change in the finger)&#xD;
  During the intraoperative period,&#xD;
  In the postoperative period&#xD;
  upon first arrival in the recovery room,&#xD;
  1st hour at the end of the operation,&#xD;
  6th hour at the end of the operation and&#xD;
  24st at the end of the operation] will be recorded.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">102</enrollment>
    <condition>Catheterization, Peripheral</condition>
    <arm_group>
      <arm_group_label>Grup 1-Forearm radial artery cannulation (FRA)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Grup 2-Distal radial artery cannulation (DRA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Distal radial artery cannulation</intervention_name>
      <description>Interventional application for invasive blood pressure monitoring</description>
      <arm_group_label>Grup 2-Distal radial artery cannulation (DRA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Forearm radial artery cannulation</intervention_name>
      <description>Interventional application for invasive blood pressure monitoring</description>
      <arm_group_label>Grup 1-Forearm radial artery cannulation (FRA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are scheduled for elective surgery&#xD;
  &#xD;
            -  Aged 18 and above&#xD;
  &#xD;
            -  ASA 1, 2, or 3 classifications&#xD;
  &#xD;
            -  Requiring intraoperative arterial cannulation&#xD;
  &#xD;
            -  At TC SBÜ Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in&#xD;
               the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under 18 years of age&#xD;
  &#xD;
            -  ASA-4 classification&#xD;
  &#xD;
            -  Presence of non-palpable arteries&#xD;
  &#xD;
            -  Presence of burns or infection at the cannulation site&#xD;
  &#xD;
            -  Peripheral vascular disease, bleeding or coagulation disorders&#xD;
  &#xD;
            -  Negative modified Allen's test, and communication disorders. The withdrawal criteria&#xD;
               for the study include a patient's desire to withdraw from the study at any stage and&#xD;
               an extended cannulation time.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Meral Erdal Erbatur, M.D.</last_name>
      <phone>+905056960814</phone>
      <email>merdalerbatur@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Osman Uzundere, M.D.</last_name>
      <phone>+905330206362</phone>
      <email>osmanuzundere@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Health Sciences University Gazi Yaşargil Training and Research Hospital:</name>
        <address>
          <city>Diyarbakır</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>32321695</PMID>
    </reference>
    <results_reference>
      <citation>Hammami 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.</citation>
      <PMID>33147107</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Meral Erdal Erbatur, MD</investigator_full_name>
      <investigator_title>Anesthesiology and reanimation spesialist</investigator_title>
    </responsible_party>
    <keyword>Invasive arterial pressure monitoring</keyword>
    <keyword>Distal radial artery cannulation</keyword>
    <keyword>Fovea radialis</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06033677
  org study id: 114-24/06/2022
  nct id: NCT06033677
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Number of interventions performed with USG guidance
  time frame: during cannulation procedure
  description: The number of attempts will be recorded as 1st attempt, 2nd attempt and 3rd and above attempts.
  measure: arterial catheterization time
  time frame: during cannulation procedure
  description: Arterial catheterization time will be evaluated as under or over 3 minutes.
  measure: Monitored arterial waveform success
  time frame: During the intraoperative period
  description: 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)
  measure: Compression time after catheter removal
  time frame: procedure (the process until the catheter is removed and the bleeding stops)
  description: After the catheter is removed, the compression time will be measured in seconds. Bleeding will be checked every 30 seconds.
  measure: complication follow-up
  time frame: Complication follow-up will be done from the beginning of cannulation procedure to the 24th hour postoperatively.
  description: 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.
  arm group label: Grup 1-Forearm radial artery cannulation (FRA)
  arm group type: Other
  description: 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.
  arm group label: Grup 2-Distal radial artery cannulation (DRA)
  arm group type: Active Comparator
  description: 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.
  intervention type: Procedure
  intervention name: Distal radial artery cannulation
  description: Interventional application for invasive blood pressure monitoring
  arm group label: Grup 2-Distal radial artery cannulation (DRA)
  intervention type: Procedure
  intervention name: Forearm radial artery cannulation
  description: Interventional application for invasive blood pressure monitoring
  arm group label: Grup 1-Forearm radial artery cannulation (FRA)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meral Erdal Erbatur, M.D.
  phone: +905056960814
  email: merdalerbatur@gmail.com
  last name: Osman Uzundere, M.D.
  phone: +905330206362
  email: osmanuzundere@gmail.com
  facility: 
  country: Turkey
  citation: 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.
  PMID: 32321695
  citation: Hammami 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.
  PMID: 33147107
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Meral Erdal Erbatur, MD
  investigator title: Anesthesiology and reanimation spesialist
  sharing ipd: No