An Exploratory Study of Perioperative Venous Access in Obese Patients

NCT06031545 | Unknown

• 1 other identifier: 20230718072255619
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Complications

Outcome Measures

Primary Outcomes (1)

• Catheter-related complication rate

  The proportion of patients with complications as a proportion of the total number of cases

  during catheter indwelling,an average of 2 weeks

Secondary Outcomes (2)

• Catheter retention days

  during catheter indwelling,an average of 2 weeks

• Completion rate of treatment via one catheter

  during catheter indwelling,an average of 2 weeks

Study Arms (2)

Long peripheral venous catheters

EXPERIMENTAL

In the test group used LPCs during the perioperative period in obese patients

Other: Long peripheral venous catheters for use

Midline catheters

OTHER

In the control group used LPCs during the perioperative period in obese patients

Other: Midline catheter

Interventions

Long peripheral venous catheters for use OTHER

Long peripheral venous catheters for use during the perioperative period in obese patients

Long peripheral venous catheters

Midline catheter OTHER

Midline catheters for use during the perioperative period in obese patients

Midline catheters

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients (BMI ≥ 30kg/m2) who are to undergo surgery.
• Expected length of hospitalisation within 2 weeks.
• Conscious and able to communicate normally.

You may not qualify if:

• It is expected that perioperative medications will need to be infused via a central venous catheter (e.g. total parenteral nutrition TPN);
• Patients with an indwelling central venous catheter on admission

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Linfang Zhao

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (11)

• 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.

  PMID: 34022156 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Zhao L, Yang X, Liu C, Yu W, Cao X, Li X, Wang J, Zhuang Y. Comparative safety and efficacy of midline catheters versus long peripheral catheters in patients undergoing bariatric surgery: a randomised controlled trial. Sci Rep. 2025 Aug 20;15(1):30534. doi: 10.1038/s41598-025-12551-0.

  PMID: 40835653 DERIVED

Study Officials

• Linfang Zhao

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linfang Zhao

CONTACT

＋86 13588819123; 3193159@zju.edu.cn

Xiuzhu Cao

CONTACT

＋86 13588477316; Caoxz@srrsh.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Not possible because of the material and characteristics of the catheter
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)