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

NCT04085042 | Completed

• 1 other identifier: Esenfc
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Catheterization, Peripheral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Successful intravenous catheterization on the first attempt

  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

• 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.

• 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.

• Patient satisfaction

  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

• Nurse satisfaction

  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

Study Arms (2)

Usual Care

NO INTERVENTION

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

PIVC pack

EXPERIMENTAL

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).

Device: PIVC pack

Interventions

PIVC pack 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.

PIVC pack

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Escola Superior de Enfermagem de Coimbra: lead
• Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.: collaborator

Study Sites (1)

Instituto Português de Oncologia de Coimbra

Coimbra, Portugal

Location

Related Publications (5)

• 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.

  PMID: 22307471 BACKGROUND

• 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.

  PMID: 27889585 BACKGROUND

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

  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.

  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.

  BACKGROUND

Study Officials

• Paulo Costa, MSc

  The Health Sciences Research Unit: Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, RN

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: May 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)