Clinical Research Directory

In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial

Background: Ultrasound guidance is an important technique to improve the success rate of internal jugular vein catheterization (IJVC) at the first-attempt, however, both long-axis in-plane and short-axis out-of-plane techniques have their own disadvantages. The T-shaped ultrasonic probe invented by us combined with the help of laser positioning and 3D printing manipulator could realize real-time bi-plane guidance of the needle short-axis out-of-plane and long-axis in-plane. With the help of the Single-operator Laser-assisted T-shaped probe, the whole process of needle insertion, guide wire placement and catheter placement can be visualized, which is expected to improve the success rate on the first-attempt. Objective: The primary outcome was the first-attempt success rate of initial RIJV catheterization without complications. The completion of the catheterization was defined as the presentation of the CVP waveform on the monitor. The secondary outcomes included first-attempt puncture success rate,first-attempt catheterisation success rate,overall catheterisation success rate,first-attempt needle tip location,first-attempt needle tip midline placement rate,number of needle direction adjustments,number of ultrasound probe repositionings, number of puncture attempts,first-attempt localisation time,first-attempt guidewire insertion success time,overall catheterisation success time. Design, Setting, and Participants: This single-center, prospective, parallel-group, randomized controlled study enrolled surgical patients over 18 years and older (ASA grade Ⅰ-Ⅳ) who required IJVC ,fully understands the benefits and risks of the study, participates voluntarily, and signs the informed consent form in the First Hospital of Jilin University. The exclusion criteria were congenital abnormal development of the internal jugular vein; prior puncture at the same site last month; puncture site injury, infection, or hematoma; right neck surgery history and neck fixation due to surgery or injury. The participants were randomized into the traditional ultrasound-guidance group or the single-operator Laser-assisted T-shaped probe ultrasound-guidance group. After inducing general anesthesia, ultrasound-guided internal jugular vein catheterization was performed by the experienced operators. Interventions: 352 patients were stratified into eight subgroups based on whether common carotid artery coverage exceeded 50% ,internal jugular vein depth exceeded 10mm , and internal jugular vein anteroposterior diameter exceeded 10mm . Each subgroup generated an independent randomisation sequence according to the block randomisation principle (T-mode ultrasound-guided group and 'long-axis plane' ultrasound-guided group). Upon enrolment, new subjects were assigned to corresponding subgroups based on stratification factors. Within each subgroup's dedicated random sequence, the allocation plan (T-shaped ultrasound guidance group or 'long-axis plane' ultrasound guidance group) was sequentially retrieved and marked. The next subject in that subgroup would receive the subsequent plan in the sequence. The operating team comprised six physicians (including two residents, two specialists, and two anaesthesiologists), who were not involved in other aspects of the study. Given the significant technical differences between the two approaches, the operators, equipment assistants, and research assistants were aware of the groupings. Conversely, participants' families were unaware of the groupings and could withdraw from the trial at any time. All data were collected and analysed by the same research assistant.

Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients

Virtual reality (VR) has increasingly been explored in medical settings as a non-pharmacological intervention for the management of pain and anxiety associated with invasive procedures. By providing immersive and interactive environments, VR is thought to modulate both sensory and emotional components of pain through mechanisms involving focused attention, cognitive engagement, and altered perception, which share similarities with hypnosis-based approaches. Evidence from previous studies, initially conducted mainly in paediatric populations and more recently extended to adults, suggests that VR may effectively reduce procedural anxiety and pain without increasing procedural duration or clinical workload. Oncology patients undergoing the placement of vascular access devices, such as peripherally inserted central catheters (PICC) and PICC-PORTs, frequently experience procedural distress, including anxiety and discomfort, related to the invasive nature of the intervention. Procedural anxiety may negatively influence patient experience, cooperation, and overall tolerance of the procedure, potentially increasing the need for pharmacological anxiolytic or analgesic support. Identifying effective, safe, and easily applicable non-pharmacological strategies to reduce distress during these procedures represents a relevant clinical goal in oncology care. The present study aims to evaluate the effectiveness of virtual reality delivered via a head-mounted display in reducing patient-reported anxiety and pain in adult oncology patients undergoing PICC or PICC-PORT insertion. This study is designed as a prospective, interventional, randomised controlled trial with a 1:1 allocation ratio using a random number generator within REDCap. A total of 120 patients will be enrolled at a single centre, the Istituto Oncologico Veneto (IRCCS), and randomly assigned to one of two study arms. Participants allocated to the intervention arm will receive VR in addition to the standard of care (VR + SOC) throughout the vascular access placement procedure, while participants in the control arm will undergo the standard procedure alone (SOC). The VR intervention will be delivered using HypnoVR, a software-based medical device classified as Class I, non-sterile, and compliant with Regulation (EU) 2017/745 on Medical Devices. The intervention will be administered via a head-mounted display with audiovisual content designed to promote relaxation, focused attention, and emotional regulation during the procedure. The primary outcome measure is the reduction of anxiety levels at the end of the procedure, assessed using the validated Visual Analogue Scale for Anxiety (VAS-A). Secondary outcomes include patient-reported pain, qualitative assessment of procedural comfort, and perceived ease of procedural management as reported by healthcare staff. Data collection will include both quantitative and qualitative measures within a mixed-methods framework. Quantitative data will be analysed using descriptive and inferential statistical methods to assess differences between study groups, while qualitative data derived from semi-structured interviews will be analysed using the Van Kaam phenomenological method to explore patients' lived experiences. The study aims to provide evidence on the role of virtual reality as a supportive, non-pharmacological option for anxiety and pain management during vascular access placement in oncology patients.

Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"\[Mesh\]) "Administration, Intravenous"\[Mesh\] ("Home Infusion Therapy"\[Mesh\]) "Parenteral Nutrition, Home"\[Mesh\] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"\[MeSH\] "Catheterization, Central Venous"\[MeSH\] "Catheterization, Peripheral" \[MeSH\] "Vascular Access Devices"\[Mesh\] )