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

Catheterization, Peripheral Clinical Trial

— MultiCat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085042
• Other study ID #: Esenfc
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Escola Superior de Enfermagem de Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheterization, Peripheral

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Portugal	Instituto Português de Oncologia de Coimbra	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
Escola Superior de Enfermagem de Coimbra	Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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.

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

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. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIVC-related complications	Evaluated through a self-report scale where the nurse identifies a set of indicators associated to the occurrence of immediate complications during the procedure (extravasation, puncture of proximal anatomical structures, hematoma, etc.)	This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months
Secondary	Successful intravenous catheterization on the first attempt	Successful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.	This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months
Secondary	Number of attempts to successful intravenous catheter placement		Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Secondary	Time to successful placement (in minutes)		From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
Secondary	Patient satisfaction	Evaluated through a self-report scale where the participant identifies a set of indicators associated to their satisfaction with the intervention, when compared to previous experiences.	This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months
Secondary	Nurse satisfaction	Evaluated through a self-report scale where the nurse identifies a set of indicators associated to their satisfaction with the intervention, when compared to previous experiences.	This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months