An Exploratory Study of Perioperative Venous Access in Obese Patients

NCT ID: NCT06031545

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-12-30

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.

Detailed 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.

Conditions

Catheter Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Long peripheral venous catheters

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

Group Type: EXPERIMENTAL

Long peripheral venous catheters for use

Intervention Type: OTHER

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

Midline catheters

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

Group Type: OTHER

Midline catheter

Intervention Type: OTHER

Midline catheters for use during the perioperative period in obese patients

Interventions

Long peripheral venous catheters for use

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

Intervention Type: OTHER

Midline catheter

Midline catheters for use during the perioperative period in obese patients

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linfang Zhao

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Linfang Zhao

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Linfang Zhao

Role: CONTACT

3193159@zju.edu.cn

＋86 13588819123

Xiuzhu Cao

Role: CONTACT

Caoxz@srrsh.com

＋86 13588477316

References

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.

Reference Type: BACKGROUND

PMID: 34022156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35248171 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28719691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28604169 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12651688 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32993628 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23141920 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26369828 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33129962 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33394637 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40835653 (View on PubMed)

Other Identifiers

20230718072255619

Identifier Type: -

Identifier Source: org_study_id