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

Study Overview
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Brief Summary
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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.

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

Conditions
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Catheterization, Peripheral

Intervention / Treatment
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* Device: PIVC pack


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Usual care during peripheral venous catheterization. Nurses will continue with the normal routine practice, by preparing all needed material individually. | |
| Experimental: PIVC pack<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheterization, Peripheral