Clinical trial NCT04085042: Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
Official title: Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Catheterization, Peripheral
Lead sponsor: Escola Superior de Enfermagem de Coimbra
Sponsor class: OTHER
Collaborators: name: Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.
First posted: 2019-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: PIVC-related complications
timeFrame: 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 outcomes:
measure: Successful intravenous catheterization on the first attempt
timeFrame: 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
measure: Number of attempts to successful intravenous catheter placement
timeFrame: Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
measure: Time to successful placement (in minutes)
timeFrame: From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
measure: Patient satisfaction
timeFrame: 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
measure: Nurse satisfaction
timeFrame: 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
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia de Coimbra
Study officials:
affiliation: The Health Sciences Research Unit: Nursing
name: Paulo Costa, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Nobre A., Martins M. Prevalência de flebite da venopunção periférica: fatores associados. Revista de Enfermagem Referência 4(16): 127-138, 2018.
citation: 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.
citation: Costa P. Gestão de Material Clínico de Bolso por Enfermeiros: fatores determinantes e diversidade microbiológica (Masters' Dissertation). Escola Superior de Enfermagem de Coimbra, 2017.