Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients

NCT ID: NCT04085042

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-11-30

Brief Summary

Peripheral intravenous catheterization (PIVC) is the most frequent invasive clinical procedure in a hospital setting, associated with significant complication rates for the patient, compromising their well-being, as well as the quality, safety, and efficacy of the care provided. The traditional approach to PIVC is considered reactive and ineffective, resulting in the exhaustion of the patients' peripheral venous access prior to consideration of other access methods and options (Moureau et al., 2012).

Evidence suggests that the safety and effectiveness of patients with a peripheral catheter are also intrinsically associated with the adequacy of materials and technologies used in clinical contexts for vein selection, as well as for catheter insertion and maintenance care (Marsh, Webster, Mihala & Rickard, 2017). Several studies point to the inadequacy of the technologies and medical devices used in this area, enhancing the occurrence of complications such as infection, phlebitis, occlusion and accidental catheter removal (Braga, 2017; Costa, 2017; Nobre & Martins, 2018).

The project investigators aim to determine whether the use of a PIVC pack will significantly reduce associated complications when compared with the usual care. Additionally, the research team aims to determine if the use of a PIVC pack will reduce the number of insertion attempts and overall procedure time, as well as improving patient and provider satisfaction.

Conditions

Catheterization, Peripheral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

Usual care during peripheral venous catheterization. Nurses will continue with the normal routine practice, by preparing all needed material individually.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PIVC pack

Nurses will use a sterile pack that includes all needed devices for peripheral intravenous catheterization according to the latest evidence (eg, cannula, swabs, disposable tourniquet, antiseptic).

Group Type: EXPERIMENTAL

PIVC pack

Intervention Type: DEVICE

The PIVC pack is a sterile container that includes inside all the need devices to perform peripheral catheterization. The pack is color-coded to inform healthcare professionals about the catheter caliber inside.

Interventions

PIVC pack

The PIVC pack is a sterile container that includes inside all the need devices to perform peripheral catheterization. The pack is color-coded to inform healthcare professionals about the catheter caliber inside.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participants who require peripheral intravenous catheterization as part of their therapeutic plan (caliber 20G or 22G);
• Participants whose primary nurse agrees to participate in the study;
• Participants who are able to give written assent or oral assent.

Exclusion Criteria

• Confused and/or disoriented participants;
• Participants who are unable to communicate orally and/or in writing.

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

Sponsors

Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.

UNKNOWN

Sponsor Role: collaborator

Escola Superior de Enfermagem de Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Paulo Costa

MSc, RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Costa, MSc

Role: PRINCIPAL_INVESTIGATOR

The Health Sciences Research Unit: Nursing

Locations

Instituto Português de Oncologia de Coimbra

Coimbra, , Portugal

Countries

Portugal

References

Moureau NL, Trick N, Nifong T, Perry C, Kelley C, Carrico R, Leavitt M, Gordon SM, Wallace J, Harvill M, Biggar C, Doll M, Papke L, Benton L, Phelan DA. Vessel health and preservation (Part 1): a new evidence-based approach to vascular access selection and management. J Vasc Access. 2012 Jul-Sep;13(3):351-6. doi: 10.5301/jva.5000042.

Reference Type: BACKGROUND

PMID: 22307471 (View on PubMed)

Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters: A Cochrane systematic review and meta-analysis. Int J Nurs Stud. 2017 Feb;67:12-19. doi: 10.1016/j.ijnurstu.2016.11.007. Epub 2016 Nov 16.

Reference Type: BACKGROUND

PMID: 27889585 (View on PubMed)

Nobre A., Martins M. Prevalência de flebite da venopunção periférica: fatores associados. Revista de Enfermagem Referência 4(16): 127-138, 2018.

Reference Type: BACKGROUND

Braga L. Práticas de enfermagem e a segurança do doente no processo de punção de vasos e na administração da terapêutica endovenosa (Doctoral Thesis). Universidade de Lisboa, 2017.

Reference Type: BACKGROUND

Costa P. Gestão de Material Clínico de Bolso por Enfermeiros: fatores determinantes e diversidade microbiológica (Masters' Dissertation). Escola Superior de Enfermagem de Coimbra, 2017.

Reference Type: BACKGROUND

Other Identifiers

Esenfc

Identifier Type: -

Identifier Source: org_study_id