Primary Intravenous Set Consumption Across 3 Branded Infusion Pumps.
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ABSTRACT:
SUBMITTER: Hedlund N
PROVIDER: S-EPMC5625969 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PurposeWe designed this study to evaluate the impact of intraoperative intravenous lidocaine infusion on postoperative opioid consumption after laparoscopic cholecystectomy.MethodsIn total, 98 patients scheduled for elective laparoscopic cholecystectomy were included and randomized. In the experimental group, intravenous lidocaine (bolus 1.5 mg/kg and continuous infusion 2 mg/kg/h) was administered intraoperatively additionally to the standard analgesia, whereas the control group received a matching placebo. Blinding existed at the level of both the patient and the investigator.ResultsOur study failed to confirm any benefit in opioid consumption, during the postoperative period. Lidocaine resulted to reduced intraoperative systolic, diastolic, and mean arterial pressure. Lidocaine administration did not change postoperative pain scores or the incidence of shoulder pain, at any time endpoint. Moreover, we did not identify any difference in terms of postoperative sedation levels and nausea rates.ConclusionOverall, lidocaine did not have any effect on postoperative analgesia after laparoscopic cholecystectomy.
| S-EPMC10191684 | biostudies-literature
Project description:BACKGROUND:The adverse event report of medical devices is one of the postmarket surveillance tools used by regulators to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. However, with the development of the related technologies and market, the number of adverse events has also been on the rise, which in turn results in the need to develop efficient tools that help to analyze adverse events monitoring data and to identify risk signals. OBJECTIVE:This study aimed to establish a hazard classification framework of medical devices and to apply it over practical adverse event data on infusion pumps. Subsequently, it aimed to analyze the risks of infusion pumps and to provide a reference for the risk management of this type of device. METHODS:The authors define a general hierarchical classification of medical device hazards. This classification is combined with the Trace Intersecting Theory to form a human-machine-environment interaction model. Such a model was applied to the dataset of 2001 to 2017 class I infusion pump recalls extracted from the Food and Drug Administration (FDA) website. This dataset does not include cases involving illegal factors. RESULTS:The proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA. According to the analytical results, an important source of product technical risk was that the infusion pumps did not infuse accurate dosage (ie, over- or underdelivery of fluid). In addition, energy hazard and product component failure were identified as the major hazard form associated with infusion pump use and as the main direct cause for adverse events in the studied cases, respectively. CONCLUSIONS:The proposed human-machine-environment interaction model, when applied to adverse event data, can help to identify the hazard forms and direct causes of adverse events associated with medical device use.
| S-EPMC6524450 | biostudies-literature
Project description: Not available
| S-EPMC7698999 | biostudies-literature
Project description:BackgroundInfusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital sectors make use of them, and they have become indispensable in therapies requiring continuity and precision in the administration of medication and/or food. As they are classified Class III (high risk) equipment, their maintenance is crucial for proper performance of the device, as well as patient and operator safety. The principal consideration of the pump is the volume infused, and the device demands great attention to detail when being calibrated. A lack of necessary care with this equipment can lead to uncertainty in volume and precision during the administration of substances. Because of this, it is essential to evaluate its reliability, to prevent possible failures at time of execution. This control aims at the quality of the intended infusion result, becoming an indication of quality.MethodsThis systematic review summarizes studies done over the last 10 years (2011 to December 2021) that address the reliability and accuracy of hospital infusion pumps, in order to identify planning of maintenance and/or other techniques used in management of the equipment. The Prisma method was applied and the databases utilized were Embase, MEDLINE/Pubmed, Web of Science, Scopus, IEEE Xplore, and Science Direct. In addition, similar reviews were studied in Prospero and the Cochrane Library. For data analysis, softwares such as Mendeley, Excel, RStudio, and VOSviewer were used, and Robvis helped in plotting risk of bias results for studies performed with Cochrane tools.ResultsThe six databases selected produced 824 studies. After applying eligibility criteria (inclusion and exclusion), removing duplicates, and applying filters 1 and 2, 15 studies were included in the present review. It was found that the most relevant sources came from the Institute of Electrical and Electronics Engineers (IEEE) and that the most relevant keywords revolved around the terms ("device failure", "infusion pumps", "adverse effects", "complications", etc.). These results made clear that there remains substantial room for improvement as it relates to the study of accuracy and reliability of infusion.ConclusionsWe verified that the reliability and precision analysis of hospital infusion pumps need to be performed in a more detailed and consistent way. New developments, considering the model and IP specification, are intended, clearly explaining the adopted methodology.
| S-EPMC10023007 | biostudies-literature
Project description: Not available
| S-EPMC8367050 | biostudies-literature
Project description:Insulin use among inpatients is high and associated with severe and regular medication errors. An initial baseline audit showed a wide variation in the prescription of intravenous insulin within the trust. These included variation in the choice of fluid prescribed, electrolyte levels not consistently checked, handwritten illegible prescriptions, and varying parameters set for adjustment of the prescription. A Variable Rate Intravenous Insulin Infusion protocol (VRIII)) was introduced to standardize intravenous insulin prescription throughout the trust by all members of the clinical team. We looked at and measured uptake and effects of the VRIII protocol in improving standardization of insulin prescription for inpatients on insulin at St George's NHS trust. The protocol was uploaded to the intranet to allow access 24 hours a day and the staff educated about it. The VRIII protocol was routinely used successfully throughout the trust. Any initial problems were addressed through education of clinical staff. The protocol has shown decreased prescribing and administrative errors, whilst demonstrating good glucose and electrolyte control. Use of a standardized protocol helps reduce medication errors and demonstrates good glycaemic control. Regular and continued education of clinical staff is necessary to maintain its efficacy.
| S-EPMC4663850 | biostudies-literature
Project description:Background: Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with the established patch pump Omnipod® (OP). Methods: Using a modified setup for tubeless pumps based on IEC 60601-2-24, the basal rate and bolus delivery of the Accu-Chek® Solo micropump system (ACS) and the A6 TouchCare® System (A6) were measured with a microgravimetric method. Bolus sizes of 0.2, 1, and 10 U, and basal rates of 0.1 and 1 U/h were evaluated in nine repetitions. For each parameter, mean deviation and number of individual boluses or 1-h basal rate windows within ±15% from target were calculated. In addition, occlusion detection time at basal rates of 0.1 and 1 U/h was determined. Results: Mean deviation of boluses of different volumes in the pumps ranged from -3.3% to +4.0% and 40%-100% of individual boluses were within ±15% of the target. During basal rate delivery, 48% to 98% of 1-h windows were within ±15% of the target with a mean deviation between -5.3% and +6.5%. In general, considerable differences between pump models were observed and deviations decreased with increasing doses. In most parameters, ACS was more accurate, and A6 less accurate, than OP. Mean occlusion detection time ranged from ∼3 to 7.5 h at 1 U/h and was >24 h or absent at 0.1 U/h. Conclusions: In this evaluation, significant differences between the tested tubeless pump models were observed that became most evident when regarding delivery errors over short time and small volumes.
| S-EPMC8080918 | biostudies-literature
Project description:Incorrect medication administration causes millions of undesirable complications worldwide every year. The problem is severe and there are many control systems in the market, yet the exact molecular composition of the solution is not monitored. Here, we propose an alarm sensor based on UV-Vis spectroscopy and refractometry. Both methods are non-invasive and non-destructive as they utilize visible light for the analysis. Moreover, they can be used for on-site or point-of-care diagnosis. UV-Vis-spectrometer detect the absorption of light caused by an electronic transition in an atom or molecule. In contrast a refractometer measures the extent of light refraction as part of a refractive index of transparent substances. Both methods can be used for quantification of dissolved analytes in transparent substances. We show that a sensor combining both methods is capable to discern most standard medications that are used in intensive care medicine. Furthermore, an integration of the alarm sensor in already existing monitoring systems is possible.
| S-EPMC9032832 | biostudies-literature
Project description:PurposeWe investigated the safety, pharmacokinetics, and efficacy of gemcitabine administered via bronchial artery infusion (BAI) and IV infusion in advanced NSCLC patients.MethodsPatients were eligible if they had received at least two prior cytotoxic chemotherapy regimens. Gemcitabine was administered via BAI as 600 mg/m2 on day one of cycle one, followed by IV as 1000 mg/m2 on day eight of cycle one, and IV on days one and eight of all subsequent cycles. Pharmacokinetics for gemcitabine and dFdU metabolite in plasma, and dFdCTP active metabolite in peripheral blood mononuclear cells (PBMC) were evaluated. Intensive pharmacokinetic sampling was performed after BAI and IV infusions during cycle one.ResultsThree male patients (age range 59-68 years) were evaluated. All patients responded with stable disease or better. One PR was observed after cycle three, and the remaining had SD. Cmax (mean ± SD) following BAI for gemcitabine, dFdCTP, and dFdU were 7.71 ± 0.13, 66.5 ± 40.6, and 38 ± 6.27 µM and following IV infusion, 17 ± 2.36, 50.8 ± 3.61, and 83.2 ± 12.3 µM, respectively. The AUCinf (mean ± SD) following BAI for gemcitabine, dFdCTP, and dFdU were 6.89 ± 1.2, 791.1 ± 551.2, and 829.9 ± 217.8 µM h and following IV infusion, 12.5 ± 3.13, 584 ± 86.6, and 1394.64 ± 682.2 µM h, respectively. The AUC and Cmax of dFdCTP after BAI were higher than IV. The median OS was 6.27 months. No grade 3 or 4 toxicity was observed. The most common side effects were all grade ≤ 2 involving nausea, vomiting, rigor, thrombocytopenia, and anemia.ConclusionsSystemic exposure to dFdCTP was higher after BAI than IV in two out of three patients.
| S-EPMC6859936 | biostudies-literature
Project description:BackgroundThe concept that upper extremities can be used as an infusion route during cardiopulmonary resuscitation in pregnant women is a reasonable recommendation considering the characteristic circulation of pregnant women; however, this method is not based on scientific evidence.Objective of the reviewWe conducted a scoping review to determine whether the infusion route should be established above the diaphragm during cardiopulmonary resuscitation in a pregnant woman.DiscussionWe included randomized controlled trials (RCTs) and non-RCTs on the infusion of fluids in pregnant women after 20 weeks of gestation requiring establishment of an infusion route due to cardiac arrest, massive bleeding, intra-abdominal bleeding, cesarean section, severe infection, or thrombosis. In total, 3150 articles from electronic database were extracted, respectively. After title and abstract review, 265 articles were extracted, and 116 articles were extracted by full-text screening, which were included in the final analysis. The 116 articles included 78 studies on infusion for pregnant women. The location of the intravenous infusion route could be confirmed in only 17 studies, all of which used the upper extremity to secure the venous route.ConclusionPregnant women undergo significant physiological changes that differ from those of normal adults, because of pressure and drainage of the inferior vena cava and pelvic veins by the enlarged uterus. Therefore, despite a lack of evidence, it seems logical to secure the infusion route above the diaphragm when resuscitating a pregnant woman.
| S-EPMC8642880 | biostudies-literature