Evaluation of the Efficacy and Safety of Midline Venous Catheters

NCT ID: NCT05835531

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2023-06-30

Brief Summary

Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. The objective of this study is to determine if the implementation of a team specialized in the placement of midline (CM) catheters reduces the incidence of infections associated with central venous catheters, decreases the cost of hospitalization, and preserves venous capital in patients admitted to ICU.

Detailed Description

Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Promoting policies to prevent catheter-associated infections (CAIs) not only reduces the number of complications but is also essential to mitigate and control the development of multidrug-resistant organisms. The mechanism by which catheters become colonized is multifactorial and complex. Mainly, bacteria access the catheter through three access routes: 1) migration of superficial organisms that follow the path of the catheter until they colonize its tip. Generally, this extraluminal form of colonization causes bacteremia in the first days of catheterization. 2) The intraluminal route is the most frequent form of colonization. Inadequate cleaning of system connections, especially in multiple-lumen and multiple-path catheters, allows bacteria to enter after the first week of use. The third colonization route is rare and is due to hematogenous seeding of bacteria from a distant focus of infection or intrinsic contamination of the infused fluid. Other factors that also favor catheter colonization are the type of material (Teflon is less friendly to the vein), the number of lumens (directly proportional to the risk of infection), the nutritional and immunological deterioration of the individual, the type of infusion administered and the insertion site.

Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. They are placed using the Seldinger surgical technique at the foot of the bed, in a simple manner, and under ultrasound guidance. The catheter enters through a peripheral vein near the elbow crease and its tip is positioned at the level of the axillary vein, facilitating the infusion of drugs with an osmolarity <600 mOsm, pH range of 5 to 9, and blood derivatives. The success rate of the procedure is almost 100%, particularly if an expert performs the catheterization.

Midline catheters are an intermediate type of catheter between peripheral and central lines. This makes them a suitable choice for patients who are chronically hospitalized in intensive care units.

The benefits of midline catheters include a longer duration of use compared to peripheral catheters (up to 28 days), a lower incidence of procedure-related complications such as pneumothorax and infections and thrombosis compared to central lines. Moreover, they enable early removal of central lines and can be a viable option for patients with challenging vascular access, aiding in the preservation of venous reserve, which is often disregarded. These factors suggest that their use can result in decreased hospital costs. Unlike centrally inserted catheters, which require a physician's intervention for placement and removal, midline catheters can be inserted and removed by nursing professionals.

Conditions

Midline Catheter

Keywords

infusion therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Catheters comparation

Assessment of incidence of complications associated with midline catheters

Intervention Type: DEVICE

Other Intervention Names

MIDLINE VENOUS CATHETERS

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

1. Pregnant women and terminal patients.

2. Skin infection at the site at the insertion site.

3. Central vascular occlusions, including patients with pacemakers.

4. Fistula for dialysis.

5. Mastectomy and lymphedema.

6. Positive blood cultures at the time of placement.

7. Coagulation disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital El Cruce

OTHER

Sponsor Role: lead

Responsible Party

Nestor Pistillo

UTIA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maximiliano Paz, BSN

Role: STUDY_DIRECTOR

Hospital El Cruce

Locations

Hospital El Cruce

San Juan Bautista, Buenos Aires, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Nestor Pistillo, MD

Role: CONTACT

Phone: 42109000

Email: nestor.pistillo@hospitalelcruce.org

Lucia Duarte, BSN

Role: CONTACT

Phone: 42109000

Email: lucymduarte1982@gmail.com

Facility Contacts

Néstor Pistillo, MD

Role: primary

References

Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5.

Reference Type: BACKGROUND

PMID: 27397766 (View on PubMed)

Zheng WM. Some exact results and approximations for cluster growth on the Cayley tree. Phys Rev A Gen Phys. 1987 Dec 15;36(12):5851-5853. doi: 10.1103/physreva.36.5851. No abstract available.

Reference Type: BACKGROUND

PMID: 9898877 (View on PubMed)

Hadaway L, Mermel LA. Midline Catheters: Could They Replace a Central Vascular Access Device? J Infus Nurs. 2022 Jul-Aug 01;45(4):220-224. doi: 10.1097/NAN.0000000000000471.

Reference Type: BACKGROUND

PMID: 35820127 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 8938155 (View on PubMed)

Other Identifiers

026/2022

Identifier Type: -

Identifier Source: org_study_id