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/NCT06031545</url>
    </required_header>
    <id_info>
      <org_study_id>20230718072255619</org_study_id>
      <nct_id>NCT06031545</nct_id>
    </id_info>
    <brief_title>An Exploratory Study of Perioperative Venous Access in Obese Patients</brief_title>
    <official_title>An Exploratory Study of Perioperative Venous Access in Obese Patients</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>
        This study is intended to explore the application effect of long peripheral intravenous&#xD;
        catheters(LPCs) and midline catheters(MCs) in the perioperative period of obese patients,&#xD;
        aiming at providing the scientific basis for the optimal perioperative venous access for the&#xD;
        obese patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is intended to explore the application effect of long peripheral intravenous&#xD;
        catheters(LPCs) and midline catheters(MCs) in the perioperative period of obese patients; at&#xD;
        the same time, the LPCs will be used as the control group and the MCs as the experimental&#xD;
        group, to compare whether the application of LPCs in the perioperative period of obese&#xD;
        patients is not inferior to that of the MCs; the comprehensive comparison of the effect of&#xD;
        the clinical application and the evaluation of the health economics, aiming at providing the&#xD;
        scientific basis for the optimal perioperative venous access for the obese patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 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>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>
    </primary_outcome>
    <secondary_outcome>
      <measure>Catheter retention days</measure>
      <time_frame>during catheter indwelling,an average of 2 weeks</time_frame>
      <description>Number of days from the day of catheter placement to the day of extubation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completion rate of treatment via one catheter</measure>
      <time_frame>during catheter indwelling,an average of 2 weeks</time_frame>
      <description>Number of patient cases in which all infusion treatments were completed via one catheter/total number of patient cases</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">528</enrollment>
    <condition>Catheter Complications</condition>
    <arm_group>
      <arm_group_label>Long peripheral venous catheters</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the test group used LPCs during the perioperative period in obese patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Midline catheters</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In the control group used LPCs during the perioperative period in obese patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Long peripheral venous catheters for use</intervention_name>
      <description>Long peripheral venous catheters for use during the perioperative period in obese patients</description>
      <arm_group_label>Long peripheral venous catheters</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Midline catheter</intervention_name>
      <description>Midline catheters for use during the perioperative period in obese patients</description>
      <arm_group_label>Midline catheters</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Obese patients (BMI ≥ 30kg/m2) who are to undergo surgery.&#xD;
  &#xD;
            -  Expected length of hospitalisation within 2 weeks.&#xD;
  &#xD;
            -  Conscious and able to communicate normally.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  It is expected that perioperative medications will need to be infused via a central&#xD;
               venous catheter (e.g. total parenteral nutrition TPN);&#xD;
  &#xD;
            -  Patients with an indwelling central venous catheter on admission&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</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>＋86 13588819123</phone>
      <email>3193159@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiuzhu Cao</last_name>
      <phone>＋86 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>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol. 2021 Jun;9(6):373-392. doi: 10.1016/S2213-8587(21)00045-0. Erratum In: Lancet Diabetes Endocrinol. 2021 Jul;9(7):e2.</citation>
      <PMID>34022156</PMID>
    </reference>
    <reference>
      <citation>Kivimaki M, Strandberg T, Pentti J, Nyberg ST, Frank P, Jokela M, Ervasti J, Suominen SB, Vahtera J, Sipila PN, Lindbohm JV, Ferrie JE. Body-mass index and risk of obesity-related complex multimorbidity: an observational multicohort study. Lancet Diabetes Endocrinol. 2022 Apr;10(4):253-263. doi: 10.1016/S2213-8587(22)00033-X. Epub 2022 Mar 4.</citation>
      <PMID>35248171</PMID>
    </reference>
    <reference>
      <citation>Zheng Y, Manson JE, Yuan C, Liang MH, Grodstein F, Stampfer MJ, Willett WC, Hu FB. Associations of Weight Gain From Early to Middle Adulthood With Major Health Outcomes Later in Life. JAMA. 2017 Jul 18;318(3):255-269. doi: 10.1001/jama.2017.7092.</citation>
      <PMID>28719691</PMID>
    </reference>
    <reference>
      <citation>GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.</citation>
      <PMID>28604169</PMID>
    </reference>
    <reference>
      <citation>Juvin P, Blarel A, Bruno F, Desmonts JM. Is peripheral line placement more difficult in obese than in lean patients? Anesth Analg. 2003 Apr;96(4):1218. doi: 10.1213/01.ANE.0000050570.85195.29.</citation>
      <PMID>12651688</PMID>
    </reference>
    <reference>
      <citation>Keogh S, Shelverton C, Flynn J, Mihala G, Mathew S, Davies KM, Marsh N, Rickard CM. Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial. BMC Med. 2020 Sep 30;18(1):252. doi: 10.1186/s12916-020-01728-1.</citation>
      <PMID>32993628</PMID>
    </reference>
    <reference>
      <citation>Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.</citation>
      <PMID>23141920</PMID>
    </reference>
    <reference>
      <citation>Chopra V, Flanders SA, Saint S, Woller SC, O'Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40. doi: 10.7326/M15-0744.</citation>
      <PMID>26369828</PMID>
    </reference>
    <reference>
      <citation>Nielsen EB, Antonsen L, Mensel C, Milandt N, Dalgaard LS, Illum BS, Arildsen H, Juhl-Olsen P. The efficacy of midline catheters-a prospective, randomized, active-controlled study. Int J Infect Dis. 2021 Jan;102:220-225. doi: 10.1016/j.ijid.2020.10.053. Epub 2020 Oct 28.</citation>
      <PMID>33129962</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>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>You can email if you need to</ipd_description>
    </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/NCT06031545
  org study id: 20230718072255619
  nct id: NCT06031545
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is intended to explore the application effect of long peripheral intravenous
        catheters(LPCs) and midline catheters(MCs) in the perioperative period of obese patients,
        aiming at providing the scientific basis for the optimal perioperative venous access for the
        obese patients.
  This study is intended to explore the application effect of long peripheral intravenous
        catheters(LPCs) and midline catheters(MCs) in the perioperative period of obese patients; at
        the same time, the LPCs will be used as the control group and the MCs as the experimental
        group, to compare whether the application of LPCs in the perioperative period of obese
        patients is not inferior to that of the MCs; the comprehensive comparison of the effect of
        the clinical application and the evaluation of the health economics, aiming at providing the
        scientific basis for the optimal perioperative venous access for the obese patients.
  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: 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: Catheter retention days
  time frame: during catheter indwelling,an average of 2 weeks
  description: Number of days from the day of catheter placement to the day of extubation
  measure: Completion rate of treatment via one catheter
  time frame: during catheter indwelling,an average of 2 weeks
  description: Number of patient cases in which all infusion treatments were completed via one catheter/total number of patient cases
  arm group label: Long peripheral venous catheters
  arm group type: Experimental
  description: In the test group used LPCs during the perioperative period in obese patients
  arm group label: Midline catheters
  arm group type: Other
  description: In the control group used LPCs during the perioperative period in obese patients
  intervention type: Other
  intervention name: Long peripheral venous catheters for use
  description: Long peripheral venous catheters for use during the perioperative period in obese patients
  arm group label: Long peripheral venous catheters
  intervention type: Other
  intervention name: Midline catheter
  description: Midline catheters for use during the perioperative period in obese patients
  arm group label: Midline catheters
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Linfang Zhao
  role: Principal Investigator
  affiliation: Sir Run Run Shaw Hospital
  last name: Linfang Zhao
  phone: ＋86 13588819123
  email: 3193159@zju.edu.cn
  last name: Xiuzhu Cao
  phone: ＋86 13588477316
  email: Caoxz@srrsh.com
  facility: 
  country: China
  citation: Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol. 2021 Jun;9(6):373-392. doi: 10.1016/S2213-8587(21)00045-0. Erratum In: Lancet Diabetes Endocrinol. 2021 Jul;9(7):e2.
  PMID: 34022156
  citation: Kivimaki M, Strandberg T, Pentti J, Nyberg ST, Frank P, Jokela M, Ervasti J, Suominen SB, Vahtera J, Sipila PN, Lindbohm JV, Ferrie JE. Body-mass index and risk of obesity-related complex multimorbidity: an observational multicohort study. Lancet Diabetes Endocrinol. 2022 Apr;10(4):253-263. doi: 10.1016/S2213-8587(22)00033-X. Epub 2022 Mar 4.
  PMID: 35248171
  citation: Zheng Y, Manson JE, Yuan C, Liang MH, Grodstein F, Stampfer MJ, Willett WC, Hu FB. Associations of Weight Gain From Early to Middle Adulthood With Major Health Outcomes Later in Life. JAMA. 2017 Jul 18;318(3):255-269. doi: 10.1001/jama.2017.7092.
  PMID: 28719691
  citation: GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
  PMID: 28604169
  citation: Juvin P, Blarel A, Bruno F, Desmonts JM. Is peripheral line placement more difficult in obese than in lean patients? Anesth Analg. 2003 Apr;96(4):1218. doi: 10.1213/01.ANE.0000050570.85195.29.
  PMID: 12651688
  citation: Keogh S, Shelverton C, Flynn J, Mihala G, Mathew S, Davies KM, Marsh N, Rickard CM. Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial. BMC Med. 2020 Sep 30;18(1):252. doi: 10.1186/s12916-020-01728-1.
  PMID: 32993628
  citation: Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
  PMID: 23141920
  citation: Chopra V, Flanders SA, Saint S, Woller SC, O'Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40. doi: 10.7326/M15-0744.
  PMID: 26369828
  citation: Nielsen EB, Antonsen L, Mensel C, Milandt N, Dalgaard LS, Illum BS, Arildsen H, Juhl-Olsen P. The efficacy of midline catheters-a prospective, randomized, active-controlled study. Int J Infect Dis. 2021 Jan;102:220-225. doi: 10.1016/j.ijid.2020.10.053. Epub 2020 Oct 28.
  PMID: 33129962
  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
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: You can email if you need to