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/NCT06014099</url>
    </required_header>
    <id_info>
      <org_study_id>IV202308</org_study_id>
      <nct_id>NCT06014099</nct_id>
    </id_info>
    <brief_title>Research on the Application of Blood Collection Through Midline Catheters of Different Lengths</brief_title>
    <official_title>Research on the Application of Blood Collection Through Midline Catheters of Different Lengths</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sir Run Run Shaw 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>
        Therefore, in this study, the investigators propose to use a randomized controlled&#xD;
        prospective open study on inpatients with difficult blood collection, by comparing the&#xD;
        effects of the application of two types of peripheral venous catheters for blood collection&#xD;
        via LPC and MC, with a view to improving the success rate of blood collection in difficult&#xD;
        peripheral venous blood collection, and providing a theoretical basis for the later&#xD;
        application of long peripheral venous catheters and midline catheters; and providing a basis&#xD;
        for optimizing the experience of venous blood collection by nurses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Using block randomization, patients were randomized in 1:1:1 blocks into experimental arm&#xD;
        1(Long peripheral venous catheter), experimental arm 2(midline catheter), and control (short&#xD;
        peripheral venous catheter) with a block length of 6. Patients have a total of 27 blocks,&#xD;
        import data into SPSS23, randomly group by SPSS, generate random numbers, and group according&#xD;
        to the size of random numbers in each unit group, the largest in the group is assigned to the&#xD;
        experimental group 1, the middle of the group is assigned to the experimental group 2, and&#xD;
        the smallest in the group is assigned to the control group. The experimental group1 used the&#xD;
        LPC for blood collection, the experimental group 2 used the MC for blood collection,and the&#xD;
        control group used the Short PIVC for blood collection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</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>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Not possible because of the material and characteristics of the catheter</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Success rate of first blood collection</measure>
      <time_frame>during catheter indwelling,an average of 2 weeks</time_frame>
      <description>Number of successful initial venous blood collection cases as a percentage of the total number of cases in this group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total success rate of blood collection</measure>
      <time_frame>during catheter indwelling,an average of 2 weeks</time_frame>
      <description>Number of patients with successful intravenous blood collection as a proportion of the number of cases in this group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Catheter-related complication rate</measure>
      <time_frame>during catheter indwelling,an average of 2 weeks</time_frame>
      <description>The proportion of patients with complications as a proportion of the total number of cases</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days for catheters to linger</measure>
      <time_frame>during catheter indwelling,an average of 2 weeks</time_frame>
      <description>The number of days between catheter insertion and catheter removal</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">162</enrollment>
    <condition>Catheter Complications</condition>
    <arm_group>
      <arm_group_label>Midline catheter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The test group2 used MC for blood collection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Long peripheral venous catheters</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the test 1 group, blood was collected using LPC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>short peripheral venous catheters</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In the control group,blood was collected using SPC.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Long peripheral venous catheters for blood collection</intervention_name>
      <description>used LPC for blood collection</description>
      <arm_group_label>Long peripheral venous catheters</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Midline catheter for blood collection</intervention_name>
      <description>used MCs for blood collection</description>
      <arm_group_label>Midline catheter</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SPCs for blood collection</intervention_name>
      <description>used SPCs for blood collection</description>
      <arm_group_label>short peripheral venous catheters</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meet the international diagnostic criteria for metabolic syndrome (such as ATP III&#xD;
               criteria or domestic Diabetes Branch of Chinese Medical Association criteria).&#xD;
  &#xD;
            -  The estimated treatment time of intravenous infusion is 1-4 weeks, and the nature of&#xD;
               the infusion drug meets the indications of LPCs and MCs.&#xD;
  &#xD;
            -  Blood samples should be collected more than 3 times during the hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A history of radiotherapy, thrombosis, and trauma at the catheter site.&#xD;
  &#xD;
            -  Plan to discharge from the hospital with the tube.&#xD;
  &#xD;
            -  Vulnerable groups, including people with mental illness, cognitive impairment,&#xD;
               critically ill patients, minors, pregnant women, illiterate, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Linfang Zhao</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sir Run Run Shaw Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Linfang Zhao</last_name>
      <phone>13588819123</phone>
      <email>3193159@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiuzhu Cao</last_name>
      <phone>13588477316</phone>
      <email>Caoxz@srrsh.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Linfang Zhao</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Linfang Zhao</last_name>
        <phone>13588819123</phone>
        <email>3193159@zju.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Xiuzhu Cao</last_name>
        <phone>13588477316</phone>
        <email>Caoxz@srrsh.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Lima-Oliveira G, Lippi G, Salvagno GL, Picheth G, Guidi GC. Laboratory Diagnostics and Quality of Blood Collection. J Med Biochem. 2015 Jul;34(3):288-294. doi: 10.2478/jomb-2014-0043. Epub 2015 Jul 14.</citation>
      <PMID>28356839</PMID>
    </reference>
    <reference>
      <citation>HO Guidelines Approved by the Guidelines Review Committee[J]. 2015.</citation>
    </reference>
    <reference>
      <citation>Tsukuda Y, Funakoshi T, Nasuhara Y, Nagano Y, Shimizu C, Iwasaki N. Venipuncture Nerve Injuries in the Upper Extremity From More Than 1 Million Procedures. J Patient Saf. 2019 Dec;15(4):299-301. doi: 10.1097/PTS.0000000000000264.</citation>
      <PMID>27314202</PMID>
    </reference>
    <reference>
      <citation>Jeong Y, Park H, Jung MJ, Kim MS, Byun S, Choi Y. Comparisons of laboratory results between two blood samplings: Venipuncture versus peripheral venous catheter-A systematic review with meta-analysis. J Clin Nurs. 2019 Oct;28(19-20):3416-3429. doi: 10.1111/jocn.14918. Epub 2019 Jun 10.</citation>
      <PMID>31112315</PMID>
    </reference>
    <reference>
      <citation>Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.</citation>
      <PMID>33394637</PMID>
    </reference>
    <reference>
      <citation>Wicker S, Stirn AV, Rabenau HF, von Gierke L, Wutzler S, Stephan C. Needlestick injuries: causes, preventability and psychological impact. Infection. 2014 Jun;42(3):549-52. doi: 10.1007/s15010-014-0598-0. Epub 2014 Feb 14.</citation>
      <PMID>24526576</PMID>
    </reference>
    <reference>
      <citation>Zhang Y, Zhang S, Chen J, Zhao R. Blood sampling from peripherally inserted central catheter is effective and safe for patients with head and neck cancers. J Vasc Access. 2021 May;22(3):424-431. doi: 10.1177/1129729820943458. Epub 2020 Aug 3.</citation>
      <PMID>32741243</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sir Run Run Shaw Hospital</investigator_affiliation>
      <investigator_full_name>Zhao Linfang</investigator_full_name>
      <investigator_title>Assitant nursing director</investigator_title>
    </responsible_party>
    <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/NCT06014099
  org study id: IV202308
  nct id: NCT06014099
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Therefore, in this study, the investigators propose to use a randomized controlled
        prospective open study on inpatients with difficult blood collection, by comparing the
        effects of the application of two types of peripheral venous catheters for blood collection
        via LPC and MC, with a view to improving the success rate of blood collection in difficult
        peripheral venous blood collection, and providing a theoretical basis for the later
        application of long peripheral venous catheters and midline catheters; and providing a basis
        for optimizing the experience of venous blood collection by nurses.
  Using block randomization, patients were randomized in 1:1:1 blocks into experimental arm
        1(Long peripheral venous catheter), experimental arm 2(midline catheter), and control (short
        peripheral venous catheter) with a block length of 6. Patients have a total of 27 blocks,
        import data into SPSS23, randomly group by SPSS, generate random numbers, and group according
        to the size of random numbers in each unit group, the largest in the group is assigned to the
        experimental group 1, the middle of the group is assigned to the experimental group 2, and
        the smallest in the group is assigned to the control group. The experimental group1 used the
        LPC for blood collection, the experimental group 2 used the MC for blood collection,and the
        control group used the Short PIVC for blood collection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: Not possible because of the material and characteristics of the catheter
  measure: Success rate of first blood collection
  time frame: during catheter indwelling,an average of 2 weeks
  description: Number of successful initial venous blood collection cases as a percentage of the total number of cases in this group
  measure: Total success rate of blood collection
  time frame: during catheter indwelling,an average of 2 weeks
  description: Number of patients with successful intravenous blood collection as a proportion of the number of cases in this group
  measure: Catheter-related complication rate
  time frame: during catheter indwelling,an average of 2 weeks
  description: The proportion of patients with complications as a proportion of the total number of cases
  measure: Number of days for catheters to linger
  time frame: during catheter indwelling,an average of 2 weeks
  description: The number of days between catheter insertion and catheter removal
  arm group label: Midline catheter
  arm group type: Experimental
  description: The test group2 used MC for blood collection.
  arm group label: Long peripheral venous catheters
  arm group type: Experimental
  description: In the test 1 group, blood was collected using LPC.
  arm group label: short peripheral venous catheters
  arm group type: Other
  description: In the control group,blood was collected using SPC.
  intervention type: Behavioral
  intervention name: Long peripheral venous catheters for blood collection
  description: used LPC for blood collection
  arm group label: Long peripheral venous catheters
  intervention type: Behavioral
  intervention name: Midline catheter for blood collection
  description: used MCs for blood collection
  arm group label: Midline catheter
  intervention type: Behavioral
  intervention name: SPCs for blood collection
  description: used SPCs for blood collection
  arm group label: short peripheral venous catheters
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Linfang Zhao
  role: Principal Investigator
  affiliation: Sir Run Run Shaw Hospital
  last name: Linfang Zhao
  phone: 13588819123
  email: 3193159@zju.edu.cn
  last name: Xiuzhu Cao
  phone: 13588477316
  email: Caoxz@srrsh.com
  facility: 
  contact: 
  contact backup: 
  country: China
  citation: Lima-Oliveira G, Lippi G, Salvagno GL, Picheth G, Guidi GC. Laboratory Diagnostics and Quality of Blood Collection. J Med Biochem. 2015 Jul;34(3):288-294. doi: 10.2478/jomb-2014-0043. Epub 2015 Jul 14.
  PMID: 28356839
  citation: HO Guidelines Approved by the Guidelines Review Committee[J]. 2015.
  citation: Tsukuda Y, Funakoshi T, Nasuhara Y, Nagano Y, Shimizu C, Iwasaki N. Venipuncture Nerve Injuries in the Upper Extremity From More Than 1 Million Procedures. J Patient Saf. 2019 Dec;15(4):299-301. doi: 10.1097/PTS.0000000000000264.
  PMID: 27314202
  citation: Jeong Y, Park H, Jung MJ, Kim MS, Byun S, Choi Y. Comparisons of laboratory results between two blood samplings: Venipuncture versus peripheral venous catheter-A systematic review with meta-analysis. J Clin Nurs. 2019 Oct;28(19-20):3416-3429. doi: 10.1111/jocn.14918. Epub 2019 Jun 10.
  PMID: 31112315
  citation: Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
  PMID: 33394637
  citation: Wicker S, Stirn AV, Rabenau HF, von Gierke L, Wutzler S, Stephan C. Needlestick injuries: causes, preventability and psychological impact. Infection. 2014 Jun;42(3):549-52. doi: 10.1007/s15010-014-0598-0. Epub 2014 Feb 14.
  PMID: 24526576
  citation: Zhang Y, Zhang S, Chen J, Zhao R. Blood sampling from peripherally inserted central catheter is effective and safe for patients with head and neck cancers. J Vasc Access. 2021 May;22(3):424-431. doi: 10.1177/1129729820943458. Epub 2020 Aug 3.
  PMID: 32741243
  responsible party type: Principal Investigator
  investigator affiliation: Sir Run Run Shaw Hospital
  investigator full name: Zhao Linfang
  investigator title: Assitant nursing director
  sharing ipd: No