A Multicentre Pilot Study of Midline Catheter's Tip at a Different Position in Antimicrobial Therapy

NCT04601597 | Completed

• 1 other identifier: IVTEAM2020-01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 6

Brief Summary

The research protocol was based on assigning patients to three different catheter tip groups and then observing the relationship between the tip and catheter-related complications when infusing antimicrobial agents.

Conditions

Infection

Keywords

Infection nursing

Outcome Measures

Primary Outcomes (7)

• Rate of Phlebitis

  Prolonged veins appear red, swollen, hot, and painful, with severe cord-like changes and indurations when touching. Mechanical phlebitis, infectious phlebitis, and thrombophlebitis are collected as phlebitis data

  through study completion, an average of 4 weeks

• Rate of Catheter-related thrombosis

  The PICC-related thrombosis in this study refers only to symptomatic thrombi, excluding asymptomatic thrombi. Catheter-related venous thrombosis was diagnosed by color Doppler ultrasound examination when the clinical manifestations were related symptoms such as swelling and pain in the upper arm of the catheterization side.

  through study completion, an average of 4 weeks

• Rate of Occlusion

  According to the degree, it is divided into complete occlusion and incomplete occlusion. When there is resistance or difficulty in flushing the tube, poor blood withdrawal or even no blood return can indicate that the catheter is incompletely occlusion; if it is difficult to flush the tube and draw blood, it can indicate that the catheter is completely occlusion.

  through study completion, an average of 4 weeks

• Rate of Catheter-Related Infection

  Including local infection of the puncture site and catheter-related blood stream infection (Catheter-Related Blood stream Infection, CRBSI). Local infection refers to redness, swelling and pain around the puncture point, or even pus; Catheter-associated bloodstream infection: refers to patients with indwelling catheters who develop bacteremia and draw blood cultures through peripheral veins for at least one positive result, accompanied by fever (\> 380C), chills, or hypotension. Other clear sources of bloodstream infection.

  through study completion, an average of 4 weeks

• Rate of Bleeding

  Bloody fluid still leaks out of catheter puncture 48 hours after catheter insertion

  through study completion, an average of 4 weeks

• Rate of Dislodgment

  The catheter slipped more than 3cm above the exposed length of the first tube placement

  through study completion, an average of 4 weeks

• Rate of exudation

  There is a slight yellow or clear liquid leakage from the catheter puncture site

  through study completion, an average of 4 weeks

Secondary Outcomes (2)

• Dwell time

  through study completion, an average of 4 weeks

• Endometrial conditions

  24 hours before intubation and after extubation

Study Arms (3)

The catheter tip was placed in the subclavian vein.

EXPERIMENTAL

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.

Device: Shu Bei Kang (China) Midline Catheters

The tip of the catheter was placed in the axillary vein of the chest wall.

EXPERIMENTAL

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.

Device: Shu Bei Kang (China) Midline Catheters

the catheter tip was located distal to the axillary vein.

EXPERIMENTAL

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.

Device: Shu Bei Kang (China) Midline Catheters

Interventions

Shu Bei Kang (China) Midline Catheters DEVICE

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 placed in the subclavian vein.; The tip of the catheter was placed in the axillary vein of the chest wall.; the catheter tip was located distal to the axillary vein.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected intravenous infusion time over 1 week In line with the indications for the use of medium-length catheters More than 18 years old Full consciousness Signed the study informed consent

You may not qualify if:

• Source of infection at the catheter insertion site History of radiation therapy, history of thrombosis, history of trauma or vascular surgery at the site of catheterization Treatment requires input of irritating or hyperosmolar solutions Patients who need to be discharged with a catheter

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (6)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujiang, China

Location

Changshu first people's Hospital

Suzhou, Jiangsu, China

Location

Kunshan first people's Hospital

Suzhou, Jiangsu, China

Location

Liaoning Provincial People's Hospital

Shenyang, Liaoning, China

Location

Zhejiang Second Hospital Affiliated to Medical College of Zhejiang University

Hangzhou, Zhejiang, 31000, China

Location

Sir Runrun Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (16)

• 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.

  PMID: 30886119 BACKGROUND

• 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.

  PMID: 27908432 BACKGROUND

• 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.

  PMID: 26847572 BACKGROUND

• 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.

  PMID: 29637197 BACKGROUND

• 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.

  PMID: 29546782 BACKGROUND

• 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.

  PMID: 33327363 BACKGROUND

• 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.

  PMID: 34851379 BACKGROUND

• 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.

  PMID: 33372744 BACKGROUND

• 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.

  PMID: 30909723 BACKGROUND

• 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.

  PMID: 34075655 BACKGROUND

• 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.

  PMID: 29532310 BACKGROUND

• 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.

  PMID: 32830599 BACKGROUND

• 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.

  PMID: 31387422 BACKGROUND

• 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.

  PMID: 31823342 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

• 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.

  PMID: 36972639 DERIVED

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 26, 2020
• Study Start: August 12, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2021
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)