The Efficiency of the Central Venous Catheter Care Protocol

NCT ID: NCT05705895

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-01

Brief Summary

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The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, which was created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

Detailed Description

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Hematopoietic stem cell transplantation (HSCT) is one of the important treatment approaches that prolongs survival in patients with hematological malignancies, immunodeficiency and some solid tumors. Despite advances in the treatment process, reasons such as recurrence of the underlying disease, organ toxicities and infectious complications adversely affect treatment success. Reasons such as high-dose chemotherapy, frequent blood sampling, stem cell reinfusion, and total parenteral nutrition applied to HSCT patients increase the need for central venous catheter insertion. Although these tools are often necessary and useful in the bone marrow transplantation process, they also bring mechanical, embolic, and infectious complications.

Central venous catheters (CVC) are one of the main applications of modern clinical treatment. Reasons such as high-dose chemotherapy, frequent blood sampling, stem cell reinfusion, and total parenteral nutrition applied to HSCT patients increase the need for central venous catheter insertion. Although these tools are often necessary and valuable in the bone marrow transplantation process, they also bring mechanical, embolic, and infectious complications. The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

This research is a pretest-posttest quasi-experimental clinical study. It is conducted with 60 patients between January 2022 and December 2023. The data is collected with Patient Information Form and Daily Patient Evaluation Chart. No application will be made to 30 patients in the control group, and catheter care will be provided to the patients of the intervention group in line with the CVC Care Protocol created by the researchers.

Conditions

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Stem Cell Transplant Complications Central Venous Catheter Exit Site Infection

Keywords

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Central Venous Catheter Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Patients and care providers know which group they are in, but the outcome assessor does not.

Study Groups

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Intervention Group

Catheter care is provided in line with the CVC care protocol developed by the researcher.

Group Type EXPERIMENTAL

CENTRAL VENOUS CATHETER CARE PROTOCOL

Intervention Type PROCEDURE

Catheter care is provided in line with the CVC care protocol developed by the researcher:

* For subsequent catheter care, a transparent sterile catheter cover impregnated with 2% chlorhexidine gluconate will be used.
* The entry point of the catheter will be wiped with a disposable sterile skin cleaning applicator containing 2% Chlorhexidine Gluconate and 70% Isopropyl Alcohol, which will be provided by the researchers, and wait for it to dry.
* Vein valve/needleless connector will be used.
* Effective manual disinfection of needle-free connectors (hubs) will be ensured before each intervention.
* Needle-free connectors will be replaced every 96 hours at the latest.
* If necessary, the catheter lumen will be washed with a disposable, positive-pressure sterile washing system containing 10 ccs 0.9% sodium chloride to be provided by the investigators.
* Pulsatile "give stop give stop" technique will be used in the washing process.

Control Group

No intervention will be made to the patients in the control group, and catheter care will be provided in line with the clinical routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CENTRAL VENOUS CATHETER CARE PROTOCOL

Catheter care is provided in line with the CVC care protocol developed by the researcher:

* For subsequent catheter care, a transparent sterile catheter cover impregnated with 2% chlorhexidine gluconate will be used.
* The entry point of the catheter will be wiped with a disposable sterile skin cleaning applicator containing 2% Chlorhexidine Gluconate and 70% Isopropyl Alcohol, which will be provided by the researchers, and wait for it to dry.
* Vein valve/needleless connector will be used.
* Effective manual disinfection of needle-free connectors (hubs) will be ensured before each intervention.
* Needle-free connectors will be replaced every 96 hours at the latest.
* If necessary, the catheter lumen will be washed with a disposable, positive-pressure sterile washing system containing 10 ccs 0.9% sodium chloride to be provided by the investigators.
* Pulsatile "give stop give stop" technique will be used in the washing process.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Being hospitalized by the Medical Oncology Clinic at in a training and research hospital to become an Autologous HSCT,
* The patient has an 8F-size, two-lumen temporary CVC,
* Over 18 years of age
* There is no communication problem,
* Agreeing to participate in the research voluntarily after being informed about the study,

Exclusion Criteria

* Using a vascular access method other than an 8F size two-lumen temporary CVC in the patient,
* Refusal to participate in the research voluntarily after being informed about the study,
* Identification of a different focus of infection in the patient.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role lead

Responsible Party

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Canan Yaranoglu

Nurse, MsN, RN, Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Canan PORUCU, MsN, RN

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Health Science University Gülhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Canan PORUCU, MsN, RN

Role: CONTACT

Phone: 05344327559

Email: [email protected]

Facility Contacts

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Canan PORUCU, MsN, RN

Role: primary

References

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Callister D, Limchaiyawat P, Eells SJ, Miller LG. Risk factors for central line-associated bloodstream infections in the era of prevention bundles. Infect Control Hosp Epidemiol. 2015 Feb;36(2):214-6. doi: 10.1017/ice.2014.32.

Reference Type BACKGROUND
PMID: 25633005 (View on PubMed)

Demiraslan H, Cevahir F, Berk E, Metan G, Cetin M, Alp E. Is surveillance for colonization of carbapenem-resistant gram-negative bacteria important in adult bone marrow transplantation units? Am J Infect Control. 2017 Jul 1;45(7):735-739. doi: 10.1016/j.ajic.2017.01.006. Epub 2017 Feb 15.

Reference Type BACKGROUND
PMID: 28214159 (View on PubMed)

Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.

Reference Type BACKGROUND
PMID: 25404862 (View on PubMed)

Gunasegaran N, See MTA, Leong ST, Yuan LX, Ang SY. A Randomized Controlled Study to Evaluate the Effectiveness of 2 Treatment Methods in Reducing Incidence of Short Peripheral Catheter-Related Phlebitis. J Infus Nurs. 2018 Mar/Apr;41(2):131-137. doi: 10.1097/NAN.0000000000000271.

Reference Type BACKGROUND
PMID: 29489709 (View on PubMed)

Flint AC, Toossi S, Chan SL, Rao VA, Sheridan W. A Simple Infection Control Protocol Durably Reduces External Ventricular Drain Infections to Near-Zero Levels. World Neurosurg. 2017 Mar;99:518-523. doi: 10.1016/j.wneu.2016.12.042. Epub 2016 Dec 22.

Reference Type BACKGROUND
PMID: 28012890 (View on PubMed)

Other Identifiers

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2021/51

Identifier Type: -

Identifier Source: org_study_id