An interventional study of Ultrasound and Near Infrared Light in Catheterization, Peripheral, sponsored by Escola Superior de Enfermagem de Coimbra. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Escola Superior de Enfermagem de Coimbra · Not applicable, Interventional, and Treatment
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.
Escola Superior de Enfermagem de Coimbra is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Ultrasonography offers visual information about the size and depth of blood vessels, potentially facilitating intravenous placement of the needle in real time.
Device: Ultrasound
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
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.
Infrared technologies allows illuminating the vein with a near-infrared light, which is absorbed by blood and reflected by adjacent tissue.
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.
Time frame: 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
Number of attempts to successful intravenous catheter placement
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: 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.
Time frame: 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.
Plan to share: No — No individual participant data will be shared with other researchers.
Ran from Oct 2018 to primary completion in Nov 2019, 13 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Escola Superior de Enfermagem de Coimbra