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The use of a volumetric infusion pump for the intra-arterial infusion of drugs.

Volumetric infusion pumps are widely used for intravenous infusions. We have extended their use to the intra-arterial infusion of drugs. An in vitro evaluation of the performance of such devices, under experimental conditions comparable to an intra-arterial infusion, was carried out. The results obtained confirmed the accuracy of volumetric infusion pumps for intra-arterial infusions. The system was found to be safe, reliable and simple in clinical practice.

Humans↗

Laparoscopic placement of a continuous hepatic artery infusion pump.

Regional liver infusion chemotherapy has been used for several decades in the treatment of isolated hepatic metastases from colorectal cancer. Although implantation of infusion pumps has traditionally required a laparotomy, minimally invasive techniques have been used recently in an attempt to reduce the morbidity resulting from pump placement. This report describes a technique for laparoscopic pump placement and presents the investigators' results with this technique.

Antineoplastic Agents↗

Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump.

Computer-controlled infusion pumps incorporating an internal model of drug pharmacokinetics can rapidly achieve and maintain constant drug concentrations in the plasma. Although these pumps offer more accurate titration of intravenous drugs than is possible with simple boluses or constant rate infusions, the choice of the plasma as the target site is arbitrary. The plasma is not the site of drug effect for most drugs. This manuscript describes two algorithms for calculation of the infusion rates necessary for a computer-controlled infusion pump to rapidly achieve, and then maintain, the desired target concentration at the site of drug effect rather than in the plasma.

Animals↗

The effect of radiation on an ambulatory chemotherapy infusion pump.

BACKGROUND: Ambulatory infusion pumps are used to deliver concurrent chemotherapy with pelvic radiation therapy for patients with rectal carcinoma. The pump is worn around the waist and may be exposed to direct as well as scattered radiation, possibly leading to a complete malfunction, requiring a new pump, and/or changes in the pump timing, with clinically significant reductions in chemotherapy administration. METHODS: Two new ambulatory chemotherapy pumps were irradiated using a 6-megavolt linear accelerator. The first pump received gradually increasing doses to determine whether a complete malfunction were possible and the approximate dose. The second pump was irradiated with a single large dose of 20 Gray (Gy) followed by smaller doses of 2 Gy to characterize the dose better. After each dose of radiation was given to both pumps, an internal self-diagnostic test and an independent assessment of the pump timing were performed. RESULTS: The first pump malfunctioned completely at a cumulative dose of 38.6 Gy after receiving an individual dose of 20 Gy. The second pump tolerated the single dose of 20 Gy without difficulty and completely malfunctioned at doses of 40-42 Gy. The second pump exhibited a reduction in pump timing by 25% at a cumulative dose of 40 Gy, which resolved spontaneously by approximately 2 hours. CONCLUSIONS: Even if removed from the direct radiation beam, an individual pump could accumulate enough radiation for complete failure during the treatment of fewer than 20 patients. Prior to a complete malfunction, the flow rate of chemotherapy may decrease by 25% for a number of hours without detection. Additional work will be necessary to define further the nature of the reduction in pump timing observed.

Ambulatory Care↗

Evaluation and selection of patient-controlled analgesia infusion pumps.

Seven PCA infusion pumps from seven manufacturers were evaluated. The condition for acceptable use of most of the units is that they not be used at low volumes that could result in overinfusion from the stored volume when an occlusion is cleared. All pumps met most accuracy, electrical safety, and performance criteria. Purchasing decisions should also take into consideration the cost of disposables, application, and medication security.

Analgesia, Patient-Controlled↗

General-purpose infusion pumps. Evaluating the B. Braun Outlook Safety Infusion System.

General-purpose infusion pumps deliver liquid medications and intravenous (i.v.) fluids to patients through i.v. or epidural routes at specified flows. They are most often used when greater accuracy or higher flows are needed than can be provided by a manually adjusted gravity administration set. In this Evaluation (which updates our October 2002 study), we present our findings for two newly evaluated pumps: the B. Braun Outlook 100 and Outlook 200. The Outlook 200 is the first general-purpose infusion pump to offer a new type of safety feature: an automated programming system. This system scans bar-coded labels on i.v. fluid containers and on patient (and sometimes clinician) identification and automatically programs this information into the pump. Unfortunately, the 200's system has not yet been successfully implemented in a clinical setting.

Equipment Design↗

Comparison of selected intravenous infusion pumps and rate regulators.

Selected intravenous infusion pumps and rate regulators were compared to determine the relative advantages and disadvantages and to formulate guidelines for purchase of these devices. Three basic types of devices were studied: infusion rate regulators, nonvolumetric (peristaltic) infusion pumps and volumetric infusion pumps. Simple syringe-type infusion pumps were not studied. After use and close study of the devices, both in the laboratory and in the clinical area, desirable features were identified. Ideally, the infusion device should operate over a wide rate range, use standard administration sets, be easy to assemble and service, have an internal battery of good power for several hours, have appropriate malfunction alarms, have an automatic keep-open device in alarm situations, be accurate under a variety of situations, and be easy for the nurse to understand and operate. All devices tested were accurate within the limits claimed by the manufacturer, although a couple of models have features which can cause gross volume errors. Overall evaluation resulted in preference of some devices over others. Cost of infusion devices and administration sets can vary widely, and this should be a factor in the final choice of intravenous infusion equipment.

Evaluation Studies as Topic↗

Problems identified with home infusion pumps.

A variety of infusion pumps and devices are available on the market today. In this article, the authors examine these products based on questionnaires sent out to typical consumers, including hospitals and caregivers. Using the results of this questionnaire, the authors identify whether or not users of home infusion pumps and devices find them difficult to operate.

Caregivers↗

General-purpose infusion pumps.

General-purpose infusion pumps deliver liquid medications to patients through intravenous or epidural routes at specified flows. They are most often used in hospitals and alternative care settings (e.g., physician' offices, patients' homes) when liquid medications need to be administered with greater accuracy or at higher flows than can be provided through a manually adjusted gravity administration set. In this Update of our February 1997 Evaluation of infusion pumps (Health Devices 26[2]), we tested 3 additional pumps from 3 suppliers. We also rated and ranked them in comparison with the 16 units from the February 1997 study that are still being produced. With a few exceptions, we tested the new pumps against the same criteria and using the same test methods as those in the previous Evaluation. However, for this Update, the focus of our findings has broadened: although we continue to place strong emphasis on the pumps' protection against gravity free-flow, we also give significant weight to their overall safety, performance, and human factors design. As a result, our ratings and rankings scheme has changed, affecting the rankings of some of the previously evaluated units. Of the 19 currently available units that have been evaluated to date, we rated 13 units Acceptable, with 5 of those units ranked above the other 8. A further 5 units were rated Conditionally Acceptable; we consider them Acceptable if they are used with the available free-flow protection. And 1 unit had performance problems that caused us to rate it Unacceptable (this unit has been recalled by its supplier; see the inset on page 162). As always, we caution readers not to base selection and purchasing decisions on our conclusions alone, but on a thorough understanding of the issues behind those conclusions, which can be gained by reading this Evaluation in its entirety and carefully reviewing the February 1997 issue.

Costs and Cost Analysis↗

Influence of infusion pump operation and flow rate on hemodynamic stability during epinephrine infusion.

OBJECTIVE: To determine whether variations in the flow rate of epinephrine solutions administered via commonly available infusion pumps lead to significant variations in blood pressure (BP) in vivo. DESIGN: Prospective, randomized, crossover study with factorial design, using infusion pumps with four different operating mechanisms (pulsatile diaphragm, linear piston/syringe, cyclic piston-valve, and linear peristaltic) and three drug delivery rates (1, 5, and 10 mL/hr). SUBJECTS: Two healthy, mixed-breed dogs (12 to 16 kg). INTERVENTIONS: Dogs were made hypotensive with methohexital bolus and continuous infusion. BP was restored to normal with constant-dose epinephrine infusion via two pumps at each rate. MEASUREMENTS: Femoral mean arterial pressure (MAP) was recorded every 10 secs. Pump-flow continuity was quantitated in vitro using a digital gravimetric technique. Variations in MAP and flow continuity were expressed by the coefficient of variation; analysis of variance was used for comparisons. RESULTS: The mean coefficients of variations for MAP varied from 3.8 +/- 3.1% (linear piston/syringe) to 6.1 +/- 6.6% (linear peristaltic), and from 3.4 +/- 2.2% (10 mL/hr) to 7.9 +/- 6.6% (1 mL/hr). The coefficients of variation for in vitro flow continuity ranged from 9 +/- 8% (linear piston-syringe) to 250 +/- 162% (pulsatile diaphragm), and from 35 +/- 44% (10 mL/hr) to 138 +/- 196% (1 mL/hr). Both the type of pump and infusion rate significantly (p < .001) influenced variation in drug delivery rate. The 1 mL/hr infusion rate significantly (p < .01) influenced MAP variation. Cyclic fluctuations in MAP of < or = 30 mm Hg were observed using the pulsatile diaphragm pump at 1 mL/hr. CONCLUSION: Factors inherent in the operating mechanisms of infusion pumps may result in clinically important hemodynamic fluctuations when administering a concentrated short-acting vasoactive medication at slow infusion rates.

Analysis of Variance↗

Intravenous infusion pumps for hospital use.

Infusion pumps provide safe and accurate delivery of intravenous fluids. Accuracy can be ensured only if the devices are used correctly. Full training is required in order to gain maximum benefit from these devices.

Equipment Design↗

Disposable infusion pumps.

PURPOSE: The properties, performance, and applications of nonelectric disposable infusion pumps are reviewed. SUMMARY: All nonelectric disposable infusion pumps exploit the same physical principle: mechanical restriction within the flow path determines the speed of pressurized fluid. The pressure generated by disposable pumps on fluid is 250-600 mm Hg, compared with 5-1200 mm Hg of pressure for electric pumps. There are several types of disposable infusion pumps, including elastomeric, positive-pressure (spring-powered and gas-pressure-powered), negative-pressure (vacuum), and patient-controlled analgesia (PCA) pumps. The accuracy of each pump's flow rate is dependent on several factors, including temperature, fluid viscosity, atmospheric pressure, back pressure, partial filling, and storage. Disposable infusion pumps can be used in many areas, including home care, PCA, patient-controlled epidural analgesia, continuous peripheral analgesia, continuous epidural analgesia, continuous i.v. analgesia, and pediatrics applications. The advantages of disposable infusion pumps include their light weight, small size, simplicity of use, independence from an external power supply, elimination of programming errors, and disposability. Disadvantages include the possibility of inaccurate flow rates, fixed reservoir volume, lack of a facility to change the flow rate and bolus-dose volume to provide adequate analgesia, inability to trace the history of the analgesia demand by patients, inability to combine PCA with background continuous infusions, and long-term cost. CONCLUSION: Despite some disadvantages and limited areas of applicability, disposable infusion pumps provide patients with advantages, such as portability, simplicity, and disposability, especially for the administration of analgesia. Understanding their physical and mechanical characteristics and their appropriate application may optimize patient care.

Analgesia, Patient-Controlled↗

Fluid delivery from infusion-pump syringes.

Fluid-delivery rates of five small-volume infusion-pump syringes were compared. The study consisted of a comparison of the infusion-pump syringes in their respective infusion pumps (1) set for continuous delivery at 1 mL/hr, (2) set for continuous delivery at 3 mL/hr, and (3) set to deliver 1-mL bolus volumes during continuous delivery at 4 mL/hr. The Life-care prefilled 30-mL syringe (Abbott), the DBL 30-mL syringe no. 770205 (DBL Inc.), and the Pump-Jet 30-mL syringe no. 1931 (International Medication Systems) were tested in the Lifecare PCA Plus II infusion pump no. 4100 (Abbott). The 30-mL Pump-Jet syringe no. 1911 (International Medication Systems) and the DBL 30-mL syringe no. 709700 (DBL Inc.) were tested in the Stratofuse PCA infusion pump (Baxter). The infusion pumps were set to deliver fluid continuously at 1 mL/hr for 30 hours, and the solutions were collected separately and weighed. The procedure was repeated with the infusion rate set at 3 mL/hr for 10 hours. For the third part of the study, each syringe was tested to deliver 1-mL boluses with 0, 5, 15, and 25 mL removed from the syringe. The solutions were collected and weighed before and after each bolus was delivered. The volume of solution collected was calculated by using the specific gravity of the solution. The syringes delivered significantly different volumes during the first hour of infusion at both the 1- and 3-mL/hr rates. Differences also existed across time for most of the syringes. Bolus volumes varied greatly after infusion of 0 or 5 mL of fluid but were acceptable for the remainder of the infusions.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗

Accuracy of drug infusion pumps under computer control.

Prototype systems implementing algorithms for automated drug infusions are typically constructed by coupling a microcomputer to a drug infusion pump through a serial communications interface. Infusion rates demanded of the infusion pump in many computed-controlled drug delivery applications are made to change at intervals much shorter than those encountered under routine clinical use. Because the ability of infusion pumps to maintain accurate flow rates during high frequency rate changes has not been documented, the purpose of this study was to validate the volumetric accuracy of three commercially available infusion pumps operating in a demanding computer-controlled application. In independent 2-h evaluations, the infusion rate demanded of each pump changed as often as every 5, 10, or 15 s using an algorithm for computer-controlled pharmacokinetic model-driven intravenous infusion. Accuracy of the infusion devices was determined gravimetrically. At all measurement times, each of the infusion pumps was accurate to within approximately +/- 5% of the expected volumetric output under each of the infusion rate intervals tested. Flow rate accuracy of +/- 5% is equal to the nominal expected accuracy of these infusion pumps in conventional clinical use.

Algorithms↗

Arterial embolization for salvage of hepatic artery infusion pumps.

PURPOSE: Hepatic artery infusion pumps (HAIPs) ideally provide for homogenous perfusion of the liver with chemotherapeutic agents. Perfusion of extrahepatic organs or asymmetric liver perfusion (ie, "misperfusion") is diagnosed by nuclear scintigraphy and precludes the use of HAIPs. The purpose of this study is to report experience in salvaging HAIPs with arterial embolization. MATERIALS AND METHODS: A single-center HAIP database was retrospectively reviewed for cases from 1999 to 2005 to identify patients who underwent angiography to treat misperfusion documented by nuclear scintigraphy. Patient demographics, nuclear scintigraphic findings before and after embolization, angiographic findings, embolization variables, and outcomes were recorded. Technical success (defined by cessation of flow to the vessel responsible for misperfusion) and clinical success (ie, successful use of the pump) were calculated. RESULTS: During the study period, 475 HAIPs were implanted. Of those, 43 (9%) had abnormal nuclear scintigraphic findings of misperfusion, but only 32 (7%) had angiographic abnormalities. In eight of 32 cases, hepatic arterial thrombosis and extravasation at the catheter tip were found, which precluded salvage by embolization. In 24 of 32 cases, a vessel presumed responsible for the misperfusion was identified and targeted for embolization. Technical success and clinical success were achieved in 21 of 24 patients (87.5%) and 19 of 24 patients (79%), respectively, who underwent 27 embolization procedures. The three technical failures (12.5%) were the result of inability to catheterize the identified vessel. CONCLUSIONS: Percutaneous arterial embolization of a vessel to correct misperfusion shown by nuclear scintigraphy is safe and effective. This approach can be expected to result in HAIP salvage in the majority of patients.

Angiography↗

Complications associated with infusion pumps implanted for spasticity.

Implanted infusion pumps are an effective method for delivering medications into the intrathecal space to reduce spasticity. Complications can occur with the surgical aspect of implantation, as well as with the hardware. We describe an 8-year experience with the implantation of 34 infusion pumps in 30 patients in whom either morphine or baclofen was used to control spasticity. The overall incidence of total complications was 62%; 24% in the Infusaid pumps, and 167% in the Medtronic pumps. The incidence and types of complications are important in informed consent as well as in the selection of pumps and connectors.

Adult↗

A randomised study of bolus vs continuous pump infusion of ifosfamide and doxorubicin with oral etoposide for small cell lung cancer.

One hundred and fifty-nine previously untreated patients with small cell lung cancer (SCLC), who were not eligible for intensive chemotherapy, were entered into a randomised study of intravenous (i.v.) doxorubicin and ifosfamide (with mesna) and oral etoposide. The i.v. drugs were given either by bolus therapy or by a continuous infusion (CI) pump over 7 days via a central venous line. Therapy was given for 6 weeks only. On weeks 1, 3 and 5 IV doxorubicin 35 mg m-2 was given with 5 days of oral etoposide 100 mg m-2 daily. On weeks 2, 4 and 6 IV ifosfamide 5 g m-2 was given with equidose mesna. The overall median survival was 25 weeks for patients in the bolus arm and 30 weeks for the CI therapy (P = 0.45). The overall response rate was 64% (18% complete response-CR) and 69% (30% CR) respectively (P = 0.13). The median WHO score for haematological toxicity was 4 for bolus therapy and 3 for CI therapy (P = 0.0007). Despite a trend for less supportive care for patients on CI therapy there were no significant differences in the use of i.v. antibodies and blood or platelet transfusions. There were fewer treatment delays due to myelotoxicity in the CI arm (P = 0.04). The median WHO score for non-haematological toxicity was 2 in both treatment groups. There was significantly less nausea (P = 0.037) but more mucositis (P = 0.01) in the CI arm. Weekly chemotherapy using CI treatment was as effective as bolus therapy. It was well accepted by patients. The assessment of quality of life in a subgroup of patients showed a statistically significant reduction in anxiety and depression for both groups of patients during therapy.

Administration, Oral↗