An Exploratory Study of Perioperative Venous Access in Obese Patients

Catheter Complications Clinical Trial

Official title:

An Exploratory Study of Perioperative Venous Access in Obese Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06031545
• Other study ID #: 20230718072255619
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Sir Run Run Shaw Hospital
• Contact: Linfang Zhao
• Phone: +86 13588819123
• Email: 3193159[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 528
• Est. completion date: December 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Catheter Complications

Intervention

Other:
• Long peripheral venous catheters for use
Long peripheral venous catheters for use during the perioperative period in obese patients
• Midline catheter
Midline catheters for use during the perioperative period in obese patients

Locations

Country	Name	City	State
China	Linfang Zhao	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Catheter retention days	Number of days from the day of catheter placement to the day of extubation	during catheter indwelling,an average of 2 weeks
Secondary	Completion rate of treatment via one catheter	Number of patient cases in which all infusion treatments were completed via one catheter/total number of patient cases	during catheter indwelling,an average of 2 weeks