Search Results (18)

Background/Objectives: Peripheral intravenous catheters are commonly employed to administer intravenous therapy to hospitalized patients. However, their use can result in complications, with phlebitis occurring in approximately 11% of cases and bloodstream infections in about 0.18%. This study aimed to enhance PIVC management in a local hospital by implementing a comprehensive care bundle to mitigate these complications. Methods: This quality improvement study involved the collection of data from 1330 PIVCs in adult patients, both prior to and following the implementation of the intervention. Data collection occurred between June 2022 and November 2023, employing the validated Peripheral Intravenous Catheter-Mini Questionnaire (PIVC-miniQ). This instrument comprises 16 observation points that assess phlebitis-related signs and symptoms, the integrity of PIVC dressings and IV connections, and the adequacy of documentation. Results: The prevalence of phlebitis decreased from 15.1% at baseline to 9.4% post-intervention (p = 0.018). Significant predictors of phlebitis included the intervention, ward, gender, and PIVC gauge. Improvements were also noted in PIVC dressing and IV connection practices, as well as documentation standards (p < 0.001). Closed integrated PIVCs outperformed ported PIVCs in the PIVC-miniQ scores after the intervention (p < 0.001). A statistically significant difference was observed in the mean PIVC-miniQ sum score post-intervention compared to baseline (p < 0.001). Conclusions: This study indicates that implementing a care bundle can enhance the quality of PIVCs and reduce the prevalence of phlebitis. Further high-quality research is needed to identify the most effective care bundles for preventing PIVC-related complications. Full article

Background/Objectives: Informed consent is a crucial part of the clinical trial enrollment process in which patients are asked to understand and provide approval for medical interventions. Consent forms can be complex and hinder patient comprehension, highlighting the need for novel tools to improve the patient enrollment experience. This feasibility study aimed to develop an immersive technology to enroll human subjects in oncology clinical trials and provide 3D avatar-based informed consent in a virtual reality (VR) environment. Methods: Clinical feasibility and the effects of head-mounted VR devices on motion sickness and educational quality were evaluated in adult oncology patients enrolled in an intravenous (IV) port placement intervention study. Participants received before- and after-questionnaires to measure their understanding of the information received in VR. A follow-up questionnaire was given four weeks post-consent to measure knowledge retention. Results: Clinical staff reported that VR technology was manageable to use. Among 16 adult participants, all reported that VR was well tolerated with no motion sickness. The mean pre-intervention knowledge score was 64.6%, with an immediate post-intervention knowledge score of 97.9%. A mean knowledge score of 93.3% four-weeks post-consent was observed among 10/16 participants who completed a follow-up questionnaire. Conclusions: These findings support that VR is well tolerated and effective at delivering information during the informed consent process for oncology clinical trials. Key limitations include the small sample size and single clinical population. Further trials are warranted to compare efficacy over traditional consenting mechanisms and include more diverse clinical populations among a wider participant pool. Full article

Background: The aim of this study was to determine whether continuous wound infiltration (CWI) can replace intravenous patient-controlled analgesia (IV PCA) and to investigate effective pain control strategies after a single-port access (SPA) laparoscopy for adnexal disease. Methods: A total of 470 patients (the CWI group [n = 109], the IV PCA group [n = 198], and the combined group [n = 163]) who underwent an SPA adnexal laparoscopy and who received CWI or IV PCA for postoperative pain management were retrospectively reviewed. The numeric rating scale (NRS) pain score at 6, 12, 24, and 48 h (h) after surgery and the total amount of fentanyl administered via IV PCA were collected. The incidence of postoperative nausea and vomiting (PONV) and the total amount of rescue antiemetic drugs administered were also evaluated. Results: The mean NRS pain scores at 6 h (combined vs. PCA vs. CWI, 3.08 vs. 3.44 vs. 3.96, p < 0.001), 12 h (2.10 vs. 2.65 vs. 2.82, p < 0.001), and 24 h (1.71 vs. 2.01 vs. 2.12, p < 0.001) after surgery were significantly lower in the combined group. CWI showed a similar pain-reduction effect after surgery compared to IV PCA, except for the acute phase (within 6 h after surgery). The incidence of PONV during the entire hospitalization period was significantly lower in the CWI group compared to the groups using IV PCA (p < 0.05). The combined group had a significantly lower incidence of PONV and use of rescue antiemetics than the IV PCA group (p < 0.05). The combined group required significantly less total PCA fentanyl compared to the IV PCA group (combined vs. PCA, 622.1 μg vs. 703.1 μg, p < 0.001). Conclusions: CWI is an effective alternative to IV PCA and has fewer side effects. Combined use of CWI and IV PCA may be an ideal pain management strategy, offering a strong pain-reduction effect and only moderate side effects. Full article

During dental scaling in dogs under general anaesthesia, contamination of the peripheral intravenous catheter (PIVC) is unavoidable due to splatter and the generated aerosol. Bacterial contamination was compared between two commonly used PIVC placement sites. Thirty-nine client-owned dogs with a minimum length from their nose to their tail base of 50 cm were randomly assigned to receive a PIVC in either their cephalic or saphenous vein. Irrespective of the PIVC placement site, brain heart infusion agar dishes were placed in the cephalic and saphenous vein areas. Their lids were closed 0, 5, and 10 min into the procedure. Contamination was measured by counting the colony-forming units after incubation on different substrates. The data were analysed with descriptive statistics, ANOVA, and ANCOVA (p < 0.05). The cephalic vein area showed a significantly higher bacterial load than the saphenous vein area (p ≈ 0.0) regardless of the length of the dog. Furthermore, the dorsal PIVC injection ports were sampled before and after scaling, and the colonies isolated were counted and subjected to MALDI-TOF-MS for identification. The bacteria mainly belonged to the genera Staphylococcus, Neisseria, and Bacillus. Our results suggest that for dental scaling in dogs, the PIVC should be placed in the pelvic limb whenever possible to reduce the potential risk of contamination. Full article

A vessel port, implanted into the central venous system, is used for long-term intravenous drug administration in oncology patients. Although essential for frequent chemotherapy and other treatments, ports can lead to complications such as infection and thrombosis. This article discusses a rare but serious complication: the displacement of a catheter fragment. A 67-year-old gastric cancer patient, experienced malignant recurrence with jaundice and bile duct infiltration post Roux-Y subtotal gastrectomy and D2 lymphadenectomy. After nine cycles of chemotherapy, a catheter fragment from the venous port detached and lodged in a branch of the pulmonary artery in segment VIII of the right lung. Thoracotomy was performed to remove the foreign body. Our aim is to report on the surgical treatment of a displaced detached catheter and to raise awareness about the potential rare complications associated with the use of vascular ports in patients undergoing chronic oncological treatment. Additionally, we screened the PubMed database for similar surgical treatment reports and compared the collected data. Venous port malfunction or non-specific patient symptoms may indicate rare complications, such as port component detachment, necessitating a multidisciplinary approach for prompt diagnosis and management in oncological patients. Full article

Background and Objectives: This study explored how nefopam, a non-opioid analgesic in a multimodal regimen, impacts postoperative pain, opioid use, and recovery quality in single-port robot-assisted laparoscopic cholecystectomy (RALC) patients with a parietal pain block, addressing challenges in postoperative pain management. Materials and Methods: Forty patients scheduled for elective single-port RALC were enrolled and randomized to receive either nefopam or normal saline intravenously. Parietal pain relief was provided through a rectus sheath block (RSB). Postoperative pain was assessed using a numeric rating scale (NRS) in the right upper quadrant (RUQ) of the abdomen, at the umbilicus, and at the shoulder. Opioid consumption and recovery quality, measured using the QoR-15K questionnaire, were also recorded. Results: The 40 patients had a mean age of 48.3 years and an average body mass index (BMI) of 26.2 kg/m². There were no significant differences in the pre- or intraoperative variables between groups. Patients receiving nefopam reported significantly lower RUQ pain scores compared to the controls, while the umbilicus and shoulder pain scores were similar. Rescue fentanyl requirements were lower in the nefopam group in both the PACU and ward. The QoR-15K questionnaire scores for nausea and vomiting were better in the nefopam group, but the overall recovery quality scores were comparable between the groups. Conclusions: Nefopam reduces RUQ pain and opioid use post-single-port RALC with a parietal pain block without markedly boosting RSB’s effect on umbilicus or shoulder pain. It may also better manage postoperative nausea and vomiting, underscoring its role in analgesia strategies for this surgery. Full article

Animals in the veterinary and experimental settings, including nonhuman primates (NHPs), often require repeated and prolonged vascular access for indications including blood sampling or administration of fluids, blood products, medication, or other therapies. A vascular access approach should be tailored to experimental or clinical use meeting the needs of the individual animal such that benefits outweigh risks. The optimal device and placement technique is based on the inherent advantages and disadvantages of specific anatomic sites and planned use. Totally implanted vascular access ports (VAPs) enable reliable central venous access for frequent sample collection and/or intravenous therapies. VAPs minimize discomfort with IV access to facilitate cooperation with handling and minimize stress-induced physiologic changes which can confound biologic data and drug responses. VAPs do not limit species-typical behavior and social group activities and are compatible with animal enrichment programs that include play and swim because there are no externalized components. VAPs are typically used long-term and demonstrate excellent durability with high patency and low complication rates over time, presenting a safe and dependable vascular access approach. Full article

Background: Intrauterine growth retardation (IUGR) is a very serious prenatal condition with 3–5% incidence of all pregnancies. It results from numerous factors, including chronic placental insufficiency. IUGR is associated with an increased risk of mortality and morbidity and is considered a major cause of fetal mortality. Currently, treatment options are significantly limited and often result in preterm delivery. Postpartum, IUGR infants also have higher risks of disease and neurological abnormalities. Methods: The PubMed database was searched using the keywords “IUGR”, “fetal growth restriction”, “treatment”, “management” and “placental insufficiency” for the period between 1975 and 2023. These terms were also combined together. Results: There were 4160 papers, reviews and articles dealing with the topic of IUGR. In total, only 15 papers directly dealt with a prepartum therapy of IUGR; 10 of these were based on an animal model. Overall, the main focus was on maternal intravenous therapy with amino acids or intraamniotic infusion. Treatment methods have been tested since the 1970s to supplement the fetuses with nutrients lacking due to chronic placental insufficiency in various ways. In some studies, pregnant women were implanted with a subcutaneous intravascular perinatal port system, thus infusing the fetuses with a continuous amino acid solution. Prolongation of pregnancy was achieved, as well as improvement in fetal growth. However, insufficient benefit was observed in infusion with commercial amino acid solution in fetuses below 28 weeks’ gestation. The authors attribute this primarily to the enormous variation in amino acid concentrations of the commercially available solutions compared with those observed in the plasma of preterm infants. These different concentrations are particularly important because differences in the fetal brain caused by metabolic changes have been demonstrated in the rabbit model. Several brain metabolites and amino acids were significantly decreased in IUGR brain tissue samples, resulting in abnormal neurodevelopment with decreased brain volume. Discussion: There are currently only a few studies and case reports with correspondingly low case numbers. Most of the studies refer to prenatal treatment by supplementation of amino acids and nutrients to prolong pregnancy and support fetal growth. However, there is no infusion solution that matches the amino acid concentrations found in fetal plasma. The commercially available solutions have mismatched amino acid concentrations and have not shown sufficient benefit in fetuses below 28 weeks’ gestation. More treatment avenues need to be explored and existing ones improved to better treat multifactorial IUGR fetuses. Full article

Rabbits are commonly used for pharmacokinetic (PK) and toxicokinetic (TK) studies in the research setting, requiring repetitive venipuncture, which can be challenging in this species. The auricular vessels are commonly used for venipuncture in rabbits. The repetitive access of these delicate vessels can lead to trauma such as hematomas causing venipuncture to become more challenging as the study progresses. In turn, this leads to missed time points or insufficient blood samples. Surgical models for chronic vascular access in rabbits are common throughout the industry. Common models include exteriorized vascular catheters and implanted vascular access ports. However, these implants come with their own complications and restrictions when used in rabbits. Therefore, the authors evaluated the use of a vascular access button (VAB), an implant commonly used in small rodents, as a refinement to the current chronic models in use in the industry. Seventeen rabbits were implanted with either single or dual channel VABs. The catheters were implanted in the femoral artery and/or vein and then tunneled subcutaneously to the button on the dorsal thoracic area. Overall, the results were outstanding, and an established model was created. The average patency rate was 316 days with several implants still patent after 2 years. The authors feel the implantation and use of a vascular access button in rabbits for routine PK studies is an excellent refinement. The rabbits tolerate the buttons extremely well with minimal issues. The patency rate is equal to or better than vascular access ports and when used with the tethering system, provides a hands-off method for blood collection and intravenous administration in rabbits during PK studies. Full article

Positron emission tomography (PET) is becoming an important tool for the investigation of emerging infectious diseases in animal models. Usually, PET imaging is performed after intravenous (IV) radiotracer administration. However, IV injections are difficult to perform in some small animals, such as golden hamsters. This challenge is particularly evident in longitudinal imaging studies, and even more so in maximum containment settings used to study high-consequence pathogens. We propose the use of intramuscular (IM) administration of 2-deoxy-2[¹⁸F]fluoro-D-glucose ([¹⁸F]F-FDG) for PET imaging of hamsters in a biosafety level 4 (BSL-4) laboratory setting. After [¹⁸F]F-FDG administration via IM or IV (through surgically implanted vascular access ports), eight hamsters underwent static or dynamic PET scans. Time–activity curves (TACs) and standardized uptake values (SUVs) in major regions of interest (ROIs) were used to compare the two injection routes. Immediately after injection, TACs differed between the two routes. At 60 min post-injection, [¹⁸F]F-FDG activity for both routes reached a plateau in most ROIs except the brain, with higher accumulation in the liver, lungs, brain, and nasal cavities observed in the IM group. IM delivery of [¹⁸F]F-FDG is an easy, safe, and reliable alternative for longitudinal PET imaging of hamsters in a BSL-4 laboratory setting. Full article

To perform robotic lung resections with views similar to those in thoracotomy, we devised a vertical port placement and confronting upside-down monitor setting: the three-arm, robotic “open-thoracotomy-view approach (OTVA)”. We described the robotic OTVA experiences focusing on segmentectomy and its technical aspects. We retrospectively reviewed 114 consecutive patients who underwent robotic lung resections (76 lobectomies and 38 segmentectomies) with OTVA using the da Vinci Xi Surgical System between February 2019 and June 2022. To identify segmental boundaries, we administered indocyanine green intravenously and used the robotic fluorescence imaging system (Firefly). In all procedures, cranial-side intrathoracic structures, which are often hidden in the conventional look-up-view method, were well visualized. The mean durations of surgery and console operation were 195 and 140 min, respectively, and 225 and 173 min, for segmentectomy and lobectomy, respectively. In segmentectomy, console operation was significantly shorter (approximately 30 min, p < 0.001) and two more staplers (8.2 ± 2.3) were used compared with lobectomy (6.6 ± 2.6, p = 0.003). In both groups, median postoperative durations of chest tube placement and hospitalization were 0 and 3 days, respectively. This three-arm robotic OTVA setting offers natural thoracotomy views and can be an alternative for segmentectomy and lobectomy. Full article

Lefamulin was the first systemic pleuromutilin antibiotic approved for intravenous and oral use in adults with community-acquired bacterial pneumonia based on two phase 3 trials (Lefamulin Evaluation Against Pneumonia [LEAP]-1 and LEAP-2). This pooled analysis evaluated lefamulin efficacy and safety in adults with community-acquired bacterial pneumonia caused by atypical pathogens (Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydia pneumoniae). In LEAP-1, participants received intravenous lefamulin 150 mg every 12 h for 5–7 days or moxifloxacin 400 mg every 24 h for 7 days, with optional intravenous-to-oral switch. In LEAP-2, participants received oral lefamulin 600 mg every 12 h for 5 days or moxifloxacin 400 mg every 24 h for 7 days. Primary outcomes were early clinical response at 96 ± 24 h after first dose and investigator assessment of clinical response at test of cure (5–10 days after last dose). Atypical pathogens were identified in 25.0% (91/364) of lefamulin-treated patients and 25.2% (87/345) of moxifloxacin-treated patients; most were identified by ≥1 standard diagnostic modality (M. pneumoniae 71.2% [52/73]; L. pneumophila 96.9% [63/65]; C. pneumoniae 79.3% [46/58]); the most common standard diagnostic modality was serology. In terms of disease severity, more than 90% of patients had CURB-65 (confusion of new onset, blood urea nitrogen > 19 mg/dL, respiratory rate ≥ 30 breaths/min, blood pressure <90 mm Hg systolic or ≤60 mm Hg diastolic, and age ≥ 65 years) scores of 0–2; approximately 50% of patients had PORT (Pneumonia Outcomes Research Team) risk class of III, and the remaining patients were more likely to have PORT risk class of II or IV versus V. In patients with atypical pathogens, early clinical response (lefamulin 84.4–96.6%; moxifloxacin 90.3–96.8%) and investigator assessment of clinical response at test of cure (lefamulin 74.1–89.7%; moxifloxacin 74.2–97.1%) were high and similar between arms. Treatment-emergent adverse event rates were similar in the lefamulin (34.1% [31/91]) and moxifloxacin (32.2% [28/87]) groups. Limitations to this analysis include its post hoc nature, the small numbers of patients infected with atypical pathogens, the possibility of PCR-based diagnostic methods to identify non-etiologically relevant pathogens, and the possibility that these findings may not be generalizable to all patients. Lefamulin as short-course empiric monotherapy, including 5-day oral therapy, was well tolerated in adults with community-acquired bacterial pneumonia and demonstrated high clinical response rates against atypical pathogens. Full article

This study, conducted in a centralized cytotoxic drug preparation unit, analyzes the effectiveness of two closed system drug transfer devices (CSTDs) in reducing leakage during antineoplastic drug compounding. Wipe/pad samplings inside and outside the preparation area were taken during surveillance programs from 2016 to 2021. All samples were analyzed for gemcitabine (GEM) contamination. In 2016, the presence of GEM in some samples and the contamination of the operators’ gloves in the absence of apparent drug spilling suggested unsealed preparation systems. In subsequent monitoring, GEM was also evaluated in the vial access device and in the access port system to the intravenous therapy bag of Texium^TM/SmartSite^TM and Equashield^® II devices after the reconstitution and preparation steps of the drug. The next checks highlighted GEM dispersion after compounding using Texium^TM/SmartSite^TM, with positive samples ranging from 9 to 23%. In contrast, gemcitabine was not present at detectable levels in the Equashield^® II system in all of the evaluated samples. The Equashield^® II closed system seems effectively able to eliminate spills and leakage during gemcitabine compounding. Since drugs with different viscosities can have different effects on CSTDs, Equashield^® II needs to be considered with other antineoplastic drugs during a structured surveillance program. Full article

Survival outcomes in ovarian cancer are poor. The aims of this Phase I progressive design study (NCT02903771) were to evaluate the maximum tolerated dose (MTD), tolerability, and antitumor activity of Cantrixil—a novel third-generation benzopyran molecule—in patients (n = 25) with advanced, recurrent/persistent epithelial ovarian, primary peritoneal, or fallopian tube cancer. All had completed ≥ 2 prior regimens; 3 (12%) had platinum-refractory disease, and 17 (68%) had platinum-resistant disease. Following intraperitoneal (IP) port placement, patients received weekly IP Cantrixil in 3-week cycles as monotherapy (Cycles 1–2), and then in combination with intravenous (IV) chemotherapy (Cycles 3–8). Part A (dose escalation) enrolled 11 patients in 6 dose-level cohorts. An MTD of 5 mg/kg was established with dose-limiting toxicity of ileus. Most treatment-related adverse events were gastrointestinal. Across Parts A and B (dose expansion), 16 (64%) patients received ≥ 1 3-week Cantrixil cycle, and had ≥ 1 post-baseline efficacy measurement available. The results show promising anti-tumor activity in monotherapy (stable disease rate of 56%) and in combination with IV chemotherapy (objective response rate of 19%, disease control rate of 56%, and median progression-free survival of 13.1 weeks). The molecular target and mechanism of action of Cantrixil are yet to be confirmed. Preliminary analysis of stem cell markers suggests that IP Cantrixil might induce ovarian cancer stem cell death and sensitize cells to standard chemotherapy, warranting further evaluation. Full article

Intravenous ports serve as vascular access and are indispensable in cancer treatment. Most studies are not based on a systematic and standardized approach. Hence, the aim of this study was to demonstrate long-term results of port implantation following a standard algorithm. A total of 2950 patients who underwent intravenous port implantation between March 2012 and December 2018 were included. Data of patients managed following a standard algorithm were analyzed for safety and long-term outcomes. The cephalic vein was the predominant choice of entry vessel. In female patients, wire assistance without use of puncture sheath was less likely and echo-guided puncture via internal jugular vein (IJV) with use of puncture sheath was more likely to be performed, compared to male patients (p < 0.0001). The procedure-related complication rate was 0.07%, and no pneumothorax, hematoma, catheter kinking, catheter fracture, or pocket erosion was reported. Catheter implantations by echo-guided puncture via IJV notably declined from 4.67% to 0.99% (p = 0.027). Mean operative time gradually declined from 37.88 min in 2012 to 23.20 min in 2018. The proposed standard algorithm for port implantation reduced the need for IJV echo-guided approach and eliminated procedure-related catastrophic complications. In addition, it shortened operative time and demonstrated good functional results. Full article