Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections

Study Overview
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Brief Summary
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The insertion of peripheral vascular catheters (PVCs) is the most often invasive procedure performed in hospital settings. During hospitalization, the majority of patients need to have a PVC inserted. These devices are not risk-free, affecting patients' safety and well-being. In clinical settings, health professionals must deal with difficult venous accesses due to the patient's age, physical characteristics, clinical status, and medication, which hinder the PVC insertion. When veins are not visible or palpable, this may lead to successive puncture attempts, causing pain to the patient and discomfort to the nurse, which results in increased costs. Guidelines state that puncture should be attempted only twice per professional, to a maximum of four attempts; against this recommendation and due to the patient's therapeutic needs and clinical situation, health professionals attempt to puncture multiple times in a single scenario. In this regard, health professionals should consider using specific technologies that help to select the vein and reduce the number of puncture attempts and catheter-related mechanical complications. Taking into account the multiplicity of existing technologies in the international market that assist health professionals in peripheral venous catheterization, ultrasound and infrared devices emerge in the literature as two of the most commonly used during this procedure. These technologies were developed with the purpose of improving peripheral intravenous catheterization success rate and thus reducing the number and extent of the negative effects of multiple or unsuccessful attempts, with the additional purpose of avoiding the frustrations of health professionals in these scenarios. However, such technologies are still underused in clinical practice, since health professionals are not familiar with the use of these devices. Moreover, the costs associated with their purchase and maintenance may be considered as excessive in relation to the traditional method. The project investigators aim to determine whether the use of either ultrasound or near-infrared vascular imaging will significantly improve the success rate of peripheral intravenous catheterization in adults on first attempt by nurses compared with the standard approach, reduce immediate related complications and improve patient and provider satisfaction.

Official Title
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Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections

Conditions
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Catheterization, Peripheral

Intervention / Treatment
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* Device: Ultrasound
* Device: Near Infrared Light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who require peripheral intravenous catheterization as part of routine care; 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Once eligibility, informed consent and assent are confirmed, participants will be randomly assigned, in the appropriate age stratum, to 1 of 2 groups: peripheral intravenous catheterization with the standard approach or with the help of either ultrasound or near-infrared vascular imaging. Randomization will be achieved with the use of an online, computer-generated program.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound imaging<br>Ultrasonography offers visual information about the size and depth of blood vessels, potentially facilitating intravenous placement of the needle in real time. | Device: Ultrasound<br>* Ultrasound allows viewing veins and surrounding anatomical structures, making it easier to perform the placement of a cannula into a peripherally located vein in real time. This process allows the cannulation of veins that are unable to be visualised or palpated.<br>|
| Experimental: Near-infrared imaging<br>Near-infrared imaging devices project near-infrared light onto the skin, which is absorbed by deoxygenated hemoglobin. The invisible image of the underlying vascular pattern is captured by the device, processed and projected, in real time, back onto the patient's skin using visible green light. This technology allows hands-free visualization of a vascular map to guide catheter placement. | Device: Near Infrared Light<br>* Infrared technologies allows illuminating the vein with a near-infrared light, which is absorbed by blood and reflected by adjacent tissue.<br>|

What is the study measuring?
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Primary 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 20 minutes. This outcome will be assessed through study completion, an average of 6 months., assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Immediate 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 20 minutes. This outcome will be assessed through study completion, an average of 6 months. | 
| Patient anxiety (State-Trait Anxiety Inventory) | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983). It can be used in clinical settings to diagnose anxiety. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. | Anxiety will be assessed about ten minutes before and ten minutes after the intervention. 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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Ultrasound, Catheterization, Peripheral, Near Infrared Light