A Multicentre Pilot Study of Midline Catheter's Tip at a Different Position in Antimicrobial Therapy
NCT ID: NCT04601597
Last Updated: 2023-02-22
Study Results
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Basic Information
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COMPLETED
NA
330 participants
INTERVENTIONAL
2020-08-12
2021-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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The catheter tip was placed in the subclavian vein.
The pre-placement catheter length measured through the body surface was greater than the actual length. Therefore, 2 cm was subtracted from the pre-puncture point to the ipsilateral sternoclavicular joint to calculate the effective catheter pre-placement length.
Shu Bei Kang (China) Midline Catheters
The procedures ① evaluation and selection of blood vessels: select the puncture vein in the middle of the patient's upper arm, ② Skin disinfection and towel laying: take the supine position, extend the upper limb to be punctured 45 \~ 90 °, disinfect the pre punctured upper limb with 75% alcohol and 5% povidone iodine. ③ Puncture vein: tie a tourniquet to fill the vein. Before puncture, use 0.2 \~ 0.4 ml of 2% lidocaine for local anesthesia. Under the guidance of ultrasound, use the puncture needle in the improved sedinger assembly for puncture. After successful puncture, insert the guide wire. ④ Delivery and confirmation of catheter position: after successful puncture, insert the dilator catheter sheath assembly, withdraw the setinger guide wire, deliver the catheter, after catheter placement, flush and seal the catheter with normal saline, and fix the catheter with sterile dressing.
The tip of the catheter was placed in the axillary vein of the chest wall.
The pre-placement length of the catheter was measured by subtracting 3-4 cm from the distance between the puncture point and ipsilateral midclavicular line. This adjustment was intended to prevent the catheter tip from entering the subclavian vein.
Shu Bei Kang (China) Midline Catheters
The procedures ① evaluation and selection of blood vessels: select the puncture vein in the middle of the patient's upper arm, ② Skin disinfection and towel laying: take the supine position, extend the upper limb to be punctured 45 \~ 90 °, disinfect the pre punctured upper limb with 75% alcohol and 5% povidone iodine. ③ Puncture vein: tie a tourniquet to fill the vein. Before puncture, use 0.2 \~ 0.4 ml of 2% lidocaine for local anesthesia. Under the guidance of ultrasound, use the puncture needle in the improved sedinger assembly for puncture. After successful puncture, insert the guide wire. ④ Delivery and confirmation of catheter position: after successful puncture, insert the dilator catheter sheath assembly, withdraw the setinger guide wire, deliver the catheter, after catheter placement, flush and seal the catheter with normal saline, and fix the catheter with sterile dressing.
the catheter tip was located distal to the axillary vein.
The measurement method of catheter pre-placement length was as follows: in cases where the catheter was punctured from the basilic and brachial veins, the distance from the pre-puncture point to the intermuscular sulcus of the ipsilateral deltoid muscle and pectoralis major muscle was measured (not surpassing the intermuscular sulcus and not reaching the axilla); however, the distance from the pre-puncture point to the ipsilateral sub shoulder or axilla was measured.
Shu Bei Kang (China) Midline Catheters
The procedures ① evaluation and selection of blood vessels: select the puncture vein in the middle of the patient's upper arm, ② Skin disinfection and towel laying: take the supine position, extend the upper limb to be punctured 45 \~ 90 °, disinfect the pre punctured upper limb with 75% alcohol and 5% povidone iodine. ③ Puncture vein: tie a tourniquet to fill the vein. Before puncture, use 0.2 \~ 0.4 ml of 2% lidocaine for local anesthesia. Under the guidance of ultrasound, use the puncture needle in the improved sedinger assembly for puncture. After successful puncture, insert the guide wire. ④ Delivery and confirmation of catheter position: after successful puncture, insert the dilator catheter sheath assembly, withdraw the setinger guide wire, deliver the catheter, after catheter placement, flush and seal the catheter with normal saline, and fix the catheter with sterile dressing.
Interventions
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Shu Bei Kang (China) Midline Catheters
The procedures ① evaluation and selection of blood vessels: select the puncture vein in the middle of the patient's upper arm, ② Skin disinfection and towel laying: take the supine position, extend the upper limb to be punctured 45 \~ 90 °, disinfect the pre punctured upper limb with 75% alcohol and 5% povidone iodine. ③ Puncture vein: tie a tourniquet to fill the vein. Before puncture, use 0.2 \~ 0.4 ml of 2% lidocaine for local anesthesia. Under the guidance of ultrasound, use the puncture needle in the improved sedinger assembly for puncture. After successful puncture, insert the guide wire. ④ Delivery and confirmation of catheter position: after successful puncture, insert the dilator catheter sheath assembly, withdraw the setinger guide wire, deliver the catheter, after catheter placement, flush and seal the catheter with normal saline, and fix the catheter with sterile dressing.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Yong Fang
Director
Locations
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Sir Runrun Shaw Hospital
Hangzhou, Zhejiang, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujiang, China
Changshu first people's Hospital
Suzhou, Jiangsu, China
Kunshan first people's Hospital
Suzhou, Jiangsu, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Zhejiang Second Hospital Affiliated to Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Chopra V, Kaatz S, Swaminathan L, Boldenow T, Snyder A, Burris R, Bernstein SJ, Flanders S. Variation in use and outcomes related to midline catheters: results from a multicentre pilot study. BMJ Qual Saf. 2019 Sep;28(9):714-720. doi: 10.1136/bmjqs-2018-008554. Epub 2019 Mar 18.
Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.
Scoppettuolo G, Pittiruti M, Pitoni S, Dolcetti L, Emoli A, Mitidieri A, Migliorini I, Annetta MG. Ultrasound-guided "short" midline catheters for difficult venous access in the emergency department: a retrospective analysis. Int J Emerg Med. 2016 Dec;9(1):3. doi: 10.1186/s12245-016-0100-0. Epub 2016 Feb 4.
Paladini A, Chiaretti A, Sellasie KW, Pittiruti M, Vento G. Ultrasound-guided placement of long peripheral cannulas in children over the age of 10 years admitted to the emergency department: a pilot study. BMJ Paediatr Open. 2018 Mar 28;2(1):e000244. doi: 10.1136/bmjpo-2017-000244. eCollection 2018.
Lisova K, Hromadkova J, Pavelkova K, Zauska V, Havlin J, Charvat J. The incidence of symptomatic upper limb venous thrombosis associated with midline catheter: Prospective observation. J Vasc Access. 2018 Sep;19(5):492-495. doi: 10.1177/1129729818761276. Epub 2018 Mar 16.
Zhao Y, Geng J, Wu X, Xiong S, Wang L, Wang J, Ma H, Wei F, Wei Z. Safety of locating the tip of a medium-long catheter at the axillary front and clavicle midline: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Dec 11;99(50):e23726. doi: 10.1097/MD.0000000000023726.
Nickel B. Does the Midline Peripheral Intravenous Catheter Have a Place in Critical Care? Crit Care Nurse. 2021 Dec 1;41(6):e1-e21. doi: 10.4037/ccn2021818.
Tripathi S, Kumar S, Kaushik S. The Practice and Complications of Midline Catheters: A Systematic Review. Crit Care Med. 2021 Feb 1;49(2):e140-e150. doi: 10.1097/CCM.0000000000004764.
Bahl A, Karabon P, Chu D. Comparison of Venous Thrombosis Complications in Midlines Versus Peripherally Inserted Central Catheters: Are Midlines the Safer Option? Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619839150. doi: 10.1177/1076029619839150.
Lu H, Yang Q, Tian B, Lyu Y, Zheng X, Xin X. A meta-analysis of the comparison of phlebitis between midline catheters and peripherally inserted central catheters in infusion therapy. Int J Nurs Pract. 2022 Apr;28(2):e12976. doi: 10.1111/ijn.12976. Epub 2021 Jun 1.
Chen W, He L, Yue L, Park M, Deng H. Spontaneous correction of misplaced peripherally inserted central catheters. Int J Cardiovasc Imaging. 2018 Jul;34(7):1005-1008. doi: 10.1007/s10554-018-1321-5. Epub 2018 Mar 12.
Passaro G, Pittiruti M, La Greca A. The fibroblastic sleeve, the neglected complication of venous access devices: A narrative review. J Vasc Access. 2021 Sep;22(5):801-813. doi: 10.1177/1129729820951035. Epub 2020 Aug 23.
Scrivens N, Sabri E, Bredeson C, McDiarmid S. Comparison of complication rates and incidences associated with different peripherally inserted central catheters (PICC) in patients with hematological malignancies: a retrospective cohort study. Leuk Lymphoma. 2020 Jan;61(1):156-164. doi: 10.1080/10428194.2019.1646908. Epub 2019 Aug 7.
Bundgaard Madsen E, Sloth E, Skov Illum B, Juhl-Olsen P. The clinical performance of midline catheters-An observational study. Acta Anaesthesiol Scand. 2020 Mar;64(3):394-399. doi: 10.1111/aas.13516. Epub 2019 Dec 22.
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.
Zhao L, Fan X, Zhao L, Cai Z, Jiang F, Zhao R. Midline catheter tip position and catheter-related complications in antimicrobial therapy: A multi-center randomized controlled trial. Int J Nurs Stud. 2023 May;141:104476. doi: 10.1016/j.ijnurstu.2023.104476. Epub 2023 Mar 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IVTEAM2020-01
Identifier Type: -
Identifier Source: org_study_id
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