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The Aerocrine exhaled nitric oxide monitoring system NIOX is cleared by the US Food and Drug Administration for monitoring therapy in asthma.

The Aerocrine exhaled nitric oxide (NO) monitoring system NIOX was cleared by the US Food and Drug Administration for clinical application in patients with asthma in May 2003. The fractional concentration of exhaled NO has been extensively researched as a marker of airway inflammation in asthma and other diseases and is now poised to enter clinical application. The American Thoracic and European Respiratory Societies' current guidelines recommend measurement at constant expiratory flow, which is difficult for some adults and children. The NIOX NO monitoring system was designed to facilitate standardized measurement according to guidelines. A clinical study was performed together with in vitro testing to obtain clearance. Exhaled NO levels were measured in unstable steroid-naive adult and pediatric asthmatic subjects and again after a 2-week treatment with inhaled corticosteroids. Exhaled NO levels decreased highly significantly, with 95% confidence limits for the decrease of -40% to -60% accompanied by clinical improvement. This trial, together with extensive in vitro testing, led to the clearance of NIOX by the US Food and Drug Administration. This article in the journal's "New products" feature section will describe background material regarding exhaled NO, special features of the NIOX NO monitoring system, and how this tool can be incorporated into clinical asthma management.

Adolescent↗

The symptom monitor. A diary for monitoring physical symptoms for cancer patients in palliative care: feasibility, reliability and compliance.

The aim of this study was to evaluate the feasibility, reliability and compliance of a new instrument, a diary to monitor physical symptoms for patients with cancer in the palliative phase of their illness. The development of the diary took place in three phases: two pilot studies and one intervention study. In Pilot I, reliability was tested within 13 pairs of patients and their proxy in a patient-proxy comparison. Pilot II was performed to test the feasibility of the instrument among 47 frail elderly. In the intervention study among patients with cancer in the palliative phase, the feasibility as well as the compliance has been tested. The phases have been completed with good results: reliability (ICC) of prevalent symptoms was above 0.75, good feasibility and good compliance. The Symptom Monitor can be used by patients and doctors as an instrument to monitor physical symptoms. The effectiveness of the use of this diary for improvement in treatment of symptoms in the palliative phase of cancer is being tested in a randomized clinical trial.

Adult↗

Monitoring sleep and breathing: methodology. Part I: Monitoring breathing.

There is considerable variation in monitoring techniques and definitions of sleep-disordered breathing. Work underway in the Sleep Heart Health Study may help to clarify these issues. Home and portable monitoring have the potential to improve cost and convenience of diagnosis and treatment of sleep disorders but are currently indicated only in specific instances. Detection and monitoring of pediatric sleep-disoriented breathing varies considerably from that of adults.

Adult↗

Evaluation of the Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor Ultrasensitive Test: comparison with the Cobas Amplicor HIV-1 Monitor test (manual specimen preparation).

In this preliminary study, we evaluated the performance of the Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor Ultrasensitive Test (CAP; Roche Molecular Systems, Branchburg, NJ) for automated specimen preparation and quantitative detection of human immunodeficiency virus type 1 (HIV-1) RNA and compared it to the Cobas Amplicor HIV-1 Monitor Ultrasensitive Test (MCA; Roche), which includes a manual sample preparation protocol. A dilution panel of a patient sample was prepared. Additionally, 584 EDTA plasma samples were collected from HIV-1 infected patients. Reproducibility was estimated with six assay runs using the dilution panel. The inter-assay coefficient of variation ranged from 39.4 to 48.4% (CAP assay) and from 34.3 to 45.6% (MCA assay), whereas the intra-assay coefficient of variation ranged from 6.2 to 58.0% (CAP assay) and from 4.4 to 57.3% (MCA assay). Comparison of CAP assay results with the HIV-1 copy number of the dilution panel determined by the MCA assay resulted in a good agreement, although the CAP results were found to be slightly lower. A significant correlation between both test systems was found when clinical samples were analyzed. The mean viral load of 152 samples, which were within the linear range of both tests, was 3.70 log(10) HIV-1 copies/ml by the CAP assay compared to 3.73 by the MCA assay. In conclusion, we could demonstrate that the new Cobas AmpliPrep/Cobas Amplicor HIV Monitor Ultrasensitive Test is reproducible and sensitive. In comparison to the assay with manual extraction, no significant difference in HIV-1 RNA copy numbers was observed.

HIV Infections↗

A field-portable plasma source monitor for real-time air particulate monitoring

In this research, a novel portable instrument for on-site, real-time air particulate monitoring was developed. It is highly desirable to use microwave plasmas for on-site, real-time environmental and occupational hazard monitoring because they can be sustained with various gases at relatively low power and possess excellent detection capabilities for both metal and nonmetal air pollutants. In the new instrument design, a microwave plasma was selected as an excitation source and was used in conjunction with atomic emission spectrometry. A small, integrated spectrometer with a charge-coupled detector (CCD) was used for optical signal detection. An efficient, in situ air-sampling system was developed for direct sampling of air particles into the plasma. Characterization and calibration of the new instrument were achieved with an in-house-fabricated high-efficiency nebulization-desolvation system. Tolerance of the microwave argon plasma source to air introduction was tested, and the operational parameters were optimized. Analytical performance and the feasibility of the newly developed portable instrument for aerosol particle analysis were evaluated. Some advantages and possible applications of the new instrument are discussed. The instrument provides an innovative tool for rapid environmental and occupational hazard monitoring.

Journal Article↗

[Demonstration of complex ventricular tachy-arrhythmias by long-term ECG monitoring: relationship to duration of monitoring].

Continuous long-term ECG monitoring over three 24-hour periods was undertaken in 42 patients with complex ventricular tachy-arrhythmias. The arrhythmias were divided by degree of severity. The lowest degree was assigned to frequent ventricular extrasystoles (more than 20 per hour). The next degree was assigned to ventricular bigeminal rhythm, while runs of extrasystoles were assigned the highest degree. In 30 patients the highest arrhythmia level was reached within the first 24-hours, in nine after a further 24 hours, in three during the third 24-hour period. Comparing the three periods of registration there were differences between the various arrhythmias, not of kind but of frequency of the arrhythmia. Simple VES and the complex forms differed in their occurrence: although of 33 patients with frequent VES (more than 20/h) 30 also had runs of VES, in six patients with runs of VES the frequency of extrasystoles was low (less than 20/h). In 70% of cases 24-hour monitoring was sufficient to record the highest level of ventricular tachy-arrhythmia. If, however, no severe arrhythmias have been recorded during this period, increasing the duration of monitoring to 48-hours can be useful. A third period or more is of little further value.

Adult↗

Comparison of urinary monitoring, faecal monitoring and erythrocyte analysis of stable isotope labels to determine magnesium absorption in human subjects.

We have evaluated urinary monitoring and erythrocyte analysis to determine Mg absorption in human subjects as alternatives to the conventional technique of faecal monitoring by stable-isotope techniques. Ten healthy adults received 2.2 mmol (25)Mg in water, together with wheat bread, followed 15 min later by intravenous injection of 0.6 mmol (26)Mg (day 1). Brilliant blue and Yb (given on day 0 and day 1 respectively) served as qualitative and quantitative faecal markers. Urine was collected for 6 d after test meal intake. Complete collections of faeces were made until excretion of the second brilliant blue marker (given on day 7). Mg isotope ratios were determined by thermal ionisation-MS in urine and faeces and by inductively coupled plasma-MS in erythrocytes. Absorption was determined based on: (1) 6 d urine pools; (2) 24 h urine pools (collected 22-46 h after test meal intake); (3) erythrocytes from a blood sample drawn on day 14; (4) complete 6 d faecal pools; (5) faecal pools based on the first three consecutive stools after excretion of the first brilliant blue marker. Differences in mean Mg absorption (42 44 %) were statistically insignificant between techniques, except when based on 6 d urine pools for which the value was significantly lower (33 (sd 7) %, P=0.0003, ANOVA). The results indicate that Mg absorption can be determined from 24 h urine pools or erythrocytes obtained 14 d after test meal intake, an alternative method to the more time-consuming and labour-intense faecal monitoring. The choice of technique depends on practical and financial considerations.

Absorption↗

Monitoring the targets of the St Vincent Declaration and the implementation of quality management in diabetes care: the DIABCARE initiative. The DIABCARE Monitoring Group of the St Vincent Declaration Steering Committee.

The St Vincent Declaration, a joint initiative on diabetes care and research of the World Health Organization (Europe) and the International Diabetes Federation (Europe), includes 5-year targets for improvement in diabetes outcomes as a central tenet. Accordingly, the establishment of state of the art monitoring and control systems is urged as a basis for the implementation of quality management. As a prerequisite for both targets, a diabetes dataset (fields and definitions) has been agreed to allow common monitoring of diabetes throughout Europe. This dataset has been further developed as the foundation stone of DiabCare, an initiative for continuous quality development in diabetes care. In a formal consensus process using the Delphi method, over 130 European diabetologists from 21 countries contributed to the development of this dataset, which includes fields covering true patient outcomes, intermediate metabolic outcomes, markers of diabetes tissue damage, risk factors, pregnancy, and life-style. The tools for documentation of the quality of health status have been developed in three formats for use in different health care settings. These tools, the DiabCare Diabetes Dataset, the DiabCare Basic Information Sheet, and the DiabCare Computer Program, are designed to allow local feedback-driven improvement in the quality of care, but are also the subject of communication protocols to compare performance between centres, regions, and countries. Whether implemented with or without the benefits of modern information technology, these initiatives can be the basis for both monitoring the targets of the St Vincent Declaration and for implementation of continuing quality development in diabetes care.

Delivery of Health Care↗

Self-monitoring of attentional behavior versus self-monitoring of productivity: effects on on-task behavior and academic response rate among learning disabled children.

I investigated the differential effects of self-monitoring of attentional behavior and self-monitoring of productivity on on-task behavior and academic response rate. Subjects were four learning disabled children with significant attentional problems. Results indicated relatively equivalent increases in on-task behavior over baseline during all treatment phases. Academic response rate also improved under both interventions, with self-monitoring of productivity showing a superior effect for one subject, an equivalent effect for one subject, and less clear results for two subjects.

Attention↗

Monitoring and evaluation of intraperitoneal bleeding (IPB) by small portable ultrasonography during transcatheter arterial embolization (TAE) in abdominal-pelvic trauma patients with shock: as a monitor for early detection of increase of IPB.

BACKGROUND/AIMS: Blunt abdominal-pelvic trauma patients with shock often require transcatheter arterial embolization (TAE), and may also require surgery if intraperitoneal bleeding (IPB) becomes massive. Deciding whether the patient should undergo surgery is highly critical. We sometimes perform TAE without attention to IPB because it has been difficult to evaluate the volume of IPB exactly during TAE. Currently we use small portable ultrasonography (PUS) as a monitor of volume of IPB during TAE. The aim of this study is to clarify the usefulness of PUS for monitoring changes in IPB during TAE. METHODOLOGY: We examined the volume of IPB by PUS during TAE without disturbing the operators of TAE. In our protocol, if the volume of IPB showed rapid increase we tried to perform a surgical procedure. The design of this study was a prospective case series study. RESULTS: We examined 26 patients. Increase of IPB was detected in 3 cases; two were undergoing angiography for ileac and renal arteries when PUS indicated increase of IPB, which drew attention to their hepatic arteries. The other was examined initially for internal ileac artery and underwent surgery because of an increase of IPB. In the other 22 cases, we confirmed no increment of IPB by PUS and continued the procedure. CONCLUSIONS: PUS is useful for deciding the order of therapeutic procedure, and is a useful monitoring instrument for increase of IPB.

Abdominal Injuries↗

Transcutaneous monitoring of partial pressure of carbon dioxide in the elderly patient: a prospective, clinical comparison with end-tidal monitoring.

STUDY OBJECTIVE: To evaluate the accuracy and precision of estimation of partial pressure of carbon dioxide (Pa(CO2)) using end-tidal or transcutaneous CO2 (TcP(CO2)) measurements during mechanical ventilation in the elderly patient. DESIGN: A prospective, observational study was conducted. SETTINGS: The study was done in the anesthesia department of a university hospital. PATIENTS: Seventeen anesthetized, mechanically ventilated patients older than 60 years were studied. INTERVENTIONS AND MEASUREMENTS: During standard sevoflurane anesthesia, and after proper calibration and an equilibration time of 30 minutes with stable hemodynamic and respiratory variables, arterial (Pa(CO2)), end-tidal (Pet(CO2)), and transcutaneous (TcP(CO2)) CO2 partial pressures were determined. In each patient, 1 to 5 sample sets (Pa(CO2), Pet(CO2), and TcP(CO2)) were obtained. MAIN RESULTS: A total of 45 sample sets were obtained from the patients studied. The Pa(CO2) values ranged between 21 and 58 mm Hg. The Pa(CO2) - Pet(CO2) tension gradient was 6 +/- 5 mmHg (95% confidence interval, -3 to 16 mmHg), whereas the Pa(CO2) - TcP(CO2) tension gradient was 2 +/- 4 mmHg (95% confidence interval, -6 to 9 mmHg) (P = 0.0005). The absolute value of the difference between Pa(CO2) and Pet(CO2) was 3 mm Hg or less in 7 of 45 sample sets (15%), whereas the absolute value of the difference between Pa(CO2) and TcP(CO2) was 3 mm Hg or less in 21 of 45 sample sets (46%) (P = 0.003). Linear regression analysis for TcP(CO2) versus Pa(CO2) showed a slope of 0.84 (r(2) = 0.73), whereas the linear regression analysis for Pet(CO2) versus Pa(CO2) showed a slope of 0.54 (r(2) = 0.50). CONCLUSION: Transcutaneous monitoring of CO(2) partial pressure gives a more accurate estimation of arterial CO(2) partial pressure than does Pet(CO2) monitoring.

Aged↗

Lung function, biological monitoring, and biological effect monitoring of gemstone cutters exposed to beryls.

OBJECTIVES: Gemstone cutters are potentially exposed to various carcinogenic and fibrogenic metals such as chromium, nickel, aluminium, and beryllium, as well as to lead. Increased beryllium concentrations had been reported in the air of workplaces of beryl cutters in Idar-Oberstein, Germany. The aim of the survey was to study the excretion of beryllium in cutters and grinders with occupational exposure to beryls--for example, aquamarines and emeralds--to examine the prevalence of beryllium sensitisation with the beryllium lymphocyte transformation test (BeLT), to examine the prevalence of lung disease induced by beryllium, to describe the internal load of the respective metals relative to work process, and to screen for genotoxic effects in this particular profession. METHODS: In a cross sectional investigation, 57 out of 100 gemstone cutters working in 12 factories in Idar-Oberstein with occupational exposure to beryls underwent medical examinations, a chest radiograph, lung function testing (spirometry, airway resistance with the interrupter technique), and biological monitoring, including measurements of aluminium, chromium, and nickel in urine as well as lead in blood. Beryllium in urine was measured with a newly developed direct electrothermal atomic absorption spectroscopy technique with a measurement limit of 0.06 microgram/l. Also, cytogenetic tests (rates of micronuclei and sister chromatid exchange), and a BeLT were performed. Airborne concentrations of beryllium were measured in three factories. As no adequate local control group was available, the cutters were categorised into those with an exposure to beryls of > 4 hours/week (group A) and < or = 4 hours/week (group B). RESULTS: Clinical, radiological, or spirometric abnormalities indicating pneumoconiosis were detected in none of the gemstone cutters. Metal concentrations in biological material were far below the respective biological limit values, and beryllium in urine was only measurable in subjects of group A. Cytogenetic investigations showed normal values which were independent of the duration of beryllium exposure. In one subject, the BeLT was positive. Beryllium stimulation indices were significantly higher in subjects with detectable beryllium in the urine than in those with beryllium concentrations below the detection limit (p < 0.05). In one factory, two out of four measurements of airborne beryllium concentrations were well above the German threshold limit value of 2 micrograms/m3 (twofold and 10-fold), and all gemstone cutters working in this factory had measurable beryllium concentrations in urine. CONCLUSION: No adverse clinical health effects were found in this cross sectional investigation of gemstone cutters working with beryls. However, an improvement in workplace hygiene is recommended, accompanied by biological monitoring of beryllium in urine.

Adult↗

Polycyclic aromatic hydrocarbons in the atmosphere: monitoring, sources, sinks and fate. I: Monitoring and sources.

This is the first of a series of two papers intended to review the state-of-the-art knowledge on atmospheric PAHs, concerning their monitoring, sources and transformation processes in the atmosphere. The monitoring section briefly introduces this class of compounds, mainly focusing on the 16 PAHs indicated by the US-EPA as priority pollutants. These compounds undergo partitioning between the gas phase and particulate, which has to be considered in the choice of the sampling methodology. Furthermore, sampling artifacts may arise from further phase transfers inside the sampling device. After sampling, extraction, clean up and detection/quantification procedures will follow. They are closely related since the choice of the extraction technique will heavily condition the clean-up step, and both procedures will place demands on the performance of the detection technique (usually GC-MS or HPLC). This is particularly true in the case of complex samples such as those arising from atmospheric sampling. The sources of atmospheric PAHs are then discussed with a particular focus on receptor models, which can allow the apportionment of PAH sources based on concentration data that can be routinely obtained by pollution control networks.

Air Pollutants↗

Effects of monitoring high-risk pregnancies and intrapartum FHR monitoring on perinates.

A protocol of chronic antepartum surveillance was initiated at the University of Illinois hospitals in 1973 to assess the impact on perinatal mortality. At the same time, a policy of unselected fetal heart rate (FHR) monitoring was initiated to judge the effect on the intrapartum stillbirth rate. The impact of both programs played a significant role in the decline of perinatal mortality rates for infants weighing more than 1 500 g, from 21.1/1 000 births in 1970--1971 to 14.4/1 000 births in the monitored years 1973 and 1974 (p less than 0.02).

Amniotic Fluid↗

St. John's wort does not interfere with therapeutic drug monitoring of 12 commonly monitored drugs using immunoassays.

St. John's wort, a popular herbal remedy for depression, is known to interact with many Western drugs because of the ability of its components to induce liver enzymes. Lower concentrations of various drugs due to increased clearance have been reported. Because immunoassays are commonly used in clinical laboratories for therapeutic drug monitoring, we studied the potential interference of St. John's wort with commonly monitored therapeutic drugs. Drug-free serum pools were supplemented with St. John's wort to achieve in vitro St. John's wort concentrations mimicking in vivo concentrations after both recommended use and overdose. Concentrations of digoxin, tricyclic antidepressants (TCAs), phenytoin, carbamazepine, theophylline, valproic acid, quinidine, phenobarbital, procainamide, and N-acetyl procainamide were measured in serum. Pooled serum specimens from patients who were taking a particular drug were also supplemented in vitro with concentrations of St. John's wort to investigate whether observed concentrations changed after supplementation with St. John's wort. The effect of St. John's wort on cyclosporine and tacrolimus (FK 506) was studied in whole blood. We found no significant interference from St. John's wort with any assay studied. Moreover, when drug-free serum was supplemented with very high concentrations of hypericin (2 microg/mL) and hyperforin (2 microg/mL) pure standard, we observed no apparent drug level with any immunoassay. The presence of both hypericin and hyperforin was also confirmed by thin layer chromatography (TLC) in both preparations of St. John's wort. We conclude that immunoassays may be used to measure levels of therapeutic drugs in patients who self-medicate with St. John's wort.

Antidepressive Agents, Tricyclic↗

Fiberoptic technique for 24-hour bile reflux monitoring. Standards and normal values for gastric monitoring.

Physiologic bile reflux was assessed in 27 in vivo test with healthy volunteers to define a standardized protocol and normal values for 24-hour enterogastric bile reflux monitoring (protocol with supine, upright, and meal phases and a free diet avoiding alcohol, smoking, and coffee, evaluation with different thresholds of absorbance units: 0.14, 0.25). In vitro tests with bile-sodium solutions demonstrated a linear dependence of absorbance for bilirubin up to 600 mumol/liter (range of the fiberoptic device: 0.0-1.0). Fluids and food might interfere with absorbances below 0.25 (exception: coffee). In vivo bile often remains in the stomach for more than 1 hr; these events were defined as reflux episodes. The upper limits for physiologic bile reflux are a percentage of total time of bile reflux of 28.2% and an average absorbance during a reflux episode of 0.62 (95th percentile with threshold 0.25). Comparing bile with pH monitoring (absorbance > 0.25 and/or pH > 4), an increase of bilirubin was found most frequently with constant pH (45%) or an increase of pH with constant bilirubin (36%). The hypothesis was drawn that bile and duodenal or pancreatic secretions may separately contribute to duodenogastric reflux.

Adult↗

Simultaneous two-level esophageal 24-hour pH monitoring in patients with mild and severe esophagitis. Does probe position influence results of esophageal monitoring?

Simultaneous ambulatory esophageal pH monitoring was performed in 10 patients (group 1) with normal distal acid exposure and in 40 patients (group 2) with pathological distal reflux. The probes were placed 5 and 10 cm above the lower esophageal sphincter to quantify variations of pH values that can be due to a displacement of pH sensor. In group 1 the median percent time with pH < 4 for total and upright monitoring periods and composite score were significantly lower at the proximal than the distal level. In group 2 all pH data were significantly lower at the proximal than the distal level. The patients with pathological reflux were subdivided into two subgroups based on endoscopic findings (mild and severe esophagitis). The patients with severe esophagitis showed a proximal acid reduction higher than in patients with mild esophagitis. Nine patients with mild esophagitis showed normal values at 10 cm, but all patients with severe esophagitis had abnormal proximal acid exposure.

Adolescent↗

Cardiopulmonary monitoring by textile electrodes without subject-awareness of being monitored.

An automated system is developed to monitor cardiopulmonary functions during sleep using electrically conductive textiles. The system obviates the need to attach transducers or electrodes to the body surface, and the subject can follow his or her normal daily routine, wearing regular pajamas to bed. Part of the bed sheet consists of electrically conductive textiles under the positions of the head, torso and legs. Respiratory activity and electrocardiograms of diagnostic quality are observed by means of the electrodes while the subject is sleeping. Respiration is sensed by means of electrical capacitance in/around the thorax. Data acquisition and storage are fully automated; thus, the subject's awareness of being monitored is greatly reduced. This system could detect disorders of cardiopulmonary functions at an early stage, if used daily in the home with the concept of chronodiagnosis.

Bedding and Linens↗