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InfectionNCT04601597

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

A study testing Shu Bei Kang (China) Midline Catheters in people with Infection, run by Sir Run Run Shaw Hospital at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection
What is being tested?
Shu Bei Kang (China) Midline Catheters
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
6 sitesChina
Study dates
12 Aug 2020to 30 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Zhejiang Second Hospital Affiliated to Medical College of Zhejiang University

    Hangzhou, Zhejiang, 31000

  • Sir Runrun Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning

  • Changshu first people's Hospital

    Suzhou, Jiangsu

  • Kunshan first people's Hospital

    Suzhou, Jiangsu

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujiang

Other trials in China

About this study

Official title: Midline Catheter Tip Position and Catheter-Related Complications in Antimicrobial Therapy- A Multi-centre Randomized Controlled Trial

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.

Read the detailed description

A prospective case-control observation study method was adopted. The investigators of each center included patients who met the inclusion and exclusion criteria and were fully informed about the content of the study, possible benefits, and risks. After obtaining informed consent, the patients were included in the method of continuous sampling and convenient sampling. According to the method of random control, the patients were grouped. In the control group, the length of catheter insertion is measured from the pre-puncture point to the shoulder or armpit. In experimental group 1, the catheter insertion length is measured from the pre-puncture point to the midpoint of the clavicle, and in the experimental group, 2 catheter insertion length is measured from the pre-puncture point to the sternoclavicular joint. With a single-blind design, patients do not know the enrollment situation. The catheter was inserted by a full-time specialist nurse of intravenous therapy under ultrasound guidance combined with the modified Seedinger technique. The catheter was inserted according to the length of different measurement methods in different groups. After the catheter was inserted, an X-ray examination was performed to determine the catheter tip position again. Data collection and follow-up observation will be conducted by researchers who have been uniformly trained. Record the baseline data of the patients in the group before catheterization, record the insertion status during catheterization, record the patient's catheter use and catheter sealing frequency every day during catheter placement, and evaluate catheter function and complications until extubation daily.

Conditions
Infection
Being tested
Shu Bei Kang (China) Midline Catheters
Keywords
Infection nursing
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shu Bei Kang (China) Midline CathetersDevice

    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.

Study groups in NCT04601597
Study groupRoleWhat they receive
The catheter tip was placed in the subclavian vein.ExperimentalThe 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.
Receives: Device: Shu Bei Kang (China) Midline Catheters
The tip of the catheter was placed in the axillary vein of the chest wall.ExperimentalThe 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.
Receives: Device: Shu Bei Kang (China) Midline Catheters
the catheter tip was located distal to the axillary vein.ExperimentalThe 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.
Receives: Device: Shu Bei Kang (China) Midline Catheters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: through study completion, an average of 4 weeks

  2. 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.

    Measured: through study completion, an average of 4 weeks

  3. 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.

    Measured: through study completion, an average of 4 weeks

  4. 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.

    Measured: through study completion, an average of 4 weeks

  5. Rate of Bleeding

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

    Measured: through study completion, an average of 4 weeks

  6. Rate of Dislodgment

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

    Measured: through study completion, an average of 4 weeks

  7. Rate of exudation

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

    Measured: through study completion, an average of 4 weeks

Secondary outcomes (2)

  1. Dwell time

    Time from tube insertion to extubation, in days

    Measured: through study completion, an average of 4 weeks

  2. Endometrial conditions

    Ultrasound examination of the vascular intima before catheterization and within 24 hours after extubation was performed. No abnormality in the intimal smoothness was negative, and abnormalities in the intimal smoothness and hyperplasia were positive.

    Measured: 24 hours before intubation and after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start12 Aug 2020
  3. Primary completion30 Dec 2020
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601597
Sponsor's protocol ID
IVTEAM2020-01
Status last verified
Feb 2023
First submitted
10 Sep 2020
Last updated
22 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30886119

  • 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.

    PubMed 27908432

  • 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.

    PubMed 26847572

  • 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.

    PubMed 29637197

  • 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.

    PubMed 29546782

  • 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.

    PubMed 33327363

  • 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.

    PubMed 34851379

  • 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.

    PubMed 33372744

  • 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.

    PubMed 30909723

  • 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.

    PubMed 34075655

  • 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.

    PubMed 29532310

  • 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.

    PubMed 32830599

  • 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.

    PubMed 31387422

  • 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.

    PubMed 31823342

  • 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.

    PubMed 26369828

Questions about this trial

What is this clinical trial studying?

A study testing Shu Bei Kang (China) Midline Catheters in people with Infection, run by Sir Run Run Shaw Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Phlebitis (time frame: through study completion, an average of 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04601597, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.

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