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PubMed1992

Bedside monitoring of anti-coagulation under LDL apheresis by means of aPTT testing with a coagulation monitor.

Optimally adjusted anticoagulation under LDL apheresis is essential for successful treatment: Excessive anticoagulation exposes the outpatient to the risk of uncontrolled hemorrhage, insufficient anticoagulation may shorten the duration of utilization of the immune-adsorption columns. A new device (coagulation monitor 512, Ciba Corning) allows individual adaptation of dosage and timing of heparin application by modifying the standard schedule (5,000 IU intravenously before treatment, 2,000 IU/h continuously). APTT was measured before and after application of heparin and then at 30-min intervals both by the coagulation monitor and by conventional laboratory methods; the respective heparin concentration was determined in addition. The correlation coefficient between the heparin concentration and both the monitor-derived and the laboratory-derived aPTT was 0.811 and 0.590, respectively. An explanation for this finding might be that the monitor avoids the influences induced by subsequent collection and testing of samples associated with laboratory procedures.

Cholesterol, LDL↗
PubMed2006

Futility approaches to interim monitoring by data monitoring committees.

Clinical trials involving participants with high risk of serious events or being exposed to a new intervention with potential serious risk are typically monitored during the course of the trial. Often, this monitoring activity is conducted by an independent group of experts, often referred to as a Data Monitoring Committee (DMC). The DMC responsibility includes monitoring for early evidence of a harmful effect or convincing evidence of a benefit. If the data are consistent and overwhelming, the DMC may recommend that a trial be terminated early. Trials may also be terminated early if the initial goal of demonstrating a benefit cannot in all likelihood be attained, or is futile. These are complicated issues and should be sorted out in the protocol and the DMC charter prior to the start of the trial before data begin to accumulate. Several statistical methods have been developed to assist a DMC in determining when a negative or harmful trend is substantial enough to render the trial continuation futile. These will be briefly summarized. However useful these methods might be, they alone are not adequate to make the decision and the DMC must take into account other issues to make a judgment.

Clinical Trials Data Monitoring Committees↗
PubMed2006

Management of patients with uncontrolled arterial hypertension--the role of electronic compliance monitoring, 24-h ambulatory blood pressure monitoring and Candesartan/HCTZ.

BACKGROUND: Incomplete drug regimen compliance (DRC) and white-coat hypertension are two of several possible causes of uncontrolled hypertension. Therefore the aim of the present study was to compare DRC in hypertensives treated with combination therapy whose blood pressures (BP) were controlled vers. uncontrolled after 4 weeks of self-monitored BP measurement. To observe the consequences in uncontrolled patients of switching one drug of the combination therapy to candesartan/HCTZ (16 mg/12.5 mg) with and without a compliance intervention program. METHODS: Self-and ambulatory-monitoring of BP were done with upper arm oscillometric devices. Patients' dosing histories were compiled electronically (MEMS, AARDEX). Patients with office blood pressure (OBP) >140/90 mmHg despite combination therapy were begun on MEMS monitoring and self BP measurement for 4 weeks of run-in. Of 62 such patients, 18 (29%) patients were normotensive according to self BP measurement and ambulatory BP measurement at 4 weeks (Group A); in the remaining 44 still uncontrolled patients, candesartan/HCTZ was substituted for one of the combination therapy drugs, with half these patients receiving passive compliance monitoring (B) and half a DRC intervention program (C). All groups were then followed for 8 weeks. RESULTS: DRC before week 4 was significantly higher in A than in the uncontrolled patients (B&C). DRC was stable during run-in A, but declined in B and C. DRC after week 4 was not different in the three groups and stayed constant over time. DRC during weekends was lower than during weekdays in all groups. In group A no significant change in blood pressure was observed with all three methods of BP measurements. In groups B and C significant reductions of systolic and diastolic BP were observed for ABPM and SBPM. After the change to candesartan/HCTZ in B&C ambulatory 24-h-BP (ABPM) was normalized in 39% of patients. CONCLUSION: Normalization of BP was associated with superior drug regimen compliance in previously uncontrolled patients treated with a combination drug regimen. Switching still-uncontrolled patients to candesartan/HCTZ significantly improved BP control and stabilized a declining DRC.

Aged↗
PubMed2006

Does end-tidal carbon dioxide monitoring detect respiratory events prior to current sedation monitoring practices?

OBJECTIVES: The value of ventilation monitoring with end-tidal carbon dioxide (ETCO2) to anticipate acute respiratory events during emergency department (ED) procedural sedation and analgesia (PSA) is unclear. The authors sought to determine if ETCO2 monitoring would reveal findings indicating an acute respiratory event earlier than indicated by current monitoring practices. METHODS: The study included a prospective convenience sample of ED patients undergoing PSA. Clinicians performed ED PSA procedures with generally accepted patient monitoring, including oxygen saturation (SpO2), and clinical ventilation assessment. A study investigator recorded ETCO2 levels and respiratory events during each PSA procedure, with clinical providers blinded to ETCO(2) levels. Acute respiratory events were defined as SpO2 < or =92%, increases in the amount of supplemental oxygen provided, use of bag-valve mask or oral/nasal airway for ventilatory assistance, repositioning or airway alignment maneuvers, and use of physical or verbal means to stimulate patients with depressed ventilation or apnea, and reversal agent administration. RESULTS: Enrollment was stopped after independent review of 20 acute respiratory events in 60 patient sedation encounters (33%). Abnormal ETCO2 findings were documented in 36 patients (60%). Seventeen patients (85%) with acute respiratory events demonstrated ETCO2 findings indicative of hypoventilation or apnea during PSA. Abnormal ETCO2 findings were documented before changes in SpO2 or clinically observed hypoventilation in 14 patients (70%) with acute respiratory events. CONCLUSIONS: Abnormal ETCO2 findings were observed with many acute respiratory events. A majority of patients with acute respiratory events had ETCO2 abnormalities that occurred before oxygen desaturation or observed hypoventilation.

Acute Disease↗
PubMed2004

Multimodality monitoring in severe traumatic brain injury: the role of brain tissue oxygenation monitoring.

Traumatic brain injury (TBI) is a major cause of morbidity and mortality with widespread social, personal, and financial implications for those who survive. TBI is caused by four main events: motor vehicle accidents, sporting injuries, falls, and assaults. Similarly to international statistics, annual incidence reports for TBI in Australia are between 100 and 288 per 100,000. Regardless of the cause of TBI, molecular and cellular derangements occur that can lead to neuronal cell death. Axonal transport disruption, ionic disruption, reduced energy formation, glutamate excitotoxicity, and free radical formation all contribute to the complex pathophysiological process of TBI-related neuronal death. Targeted pharmacological therapy has not proved beneficial in improving patient outcome, and monitoring and maintenance of various physiological parameters is the mainstay of current therapy. Parameters monitored include arterial blood pressure, blood gases, intracranial pressure, cerebral perfusion pressure, cerebral blood flow, and direct brain tissue oxygen measurement (ptiO2). Currently, indirect brain oximetry is used for cerebral oxygenation determination, which provides some information regarding global oxygenation levels. A newly developed oximetry technique, has shown promising results for the early detection of cerebral ischemia. ptiO2 monitoring provides a safe, easy, and sensitive method of regional brain oximetry, providing a greater understanding of neurophysiological derangements and the potential for correcting abnormal oxygenation earlier, thus improving patient outcome. This article reviews the current status of bedside monitoring for patients with TBI and considers whether ptiO2 has a role in the modern intensive care setting.

Brain↗
PubMed1994

The international normalized ratio (INR) for monitoring warfarin therapy: reliability and relation to other monitoring methods.

OBJECTIVE: To enhance understanding of the reliability of the international normalized ratio (INR) for monitoring warfarin therapy and its relation to other monitoring techniques. DESIGN: Prospective cohort study. SETTING: A university hospital. PATIENTS: 79 patients attending an anticoagulation clinic. MEASUREMENTS: International normalized ratios obtained with a portable capillary monitor (Coumatrak) and the following from a simultaneous plasma sample: INRs from prothrombin times done with six thromboplastins, prothrombin-proconvertin (P&P) test activity, specific prothrombin activity, and native prothrombin antigen. RESULTS: Converting to INRs failed to standardize prothrombin time results obtained with high- and low-sensitivity thromboplastins. Coumatrak INRs correlated best with INRs obtained with high-sensitivity thromboplastins. The INR range of 2.0 to 3.0 corresponded to a P&P range of 30% to 13%, a native plasma prothrombin antigen range of 56 to 24 micrograms/mL, and a specific prothrombin activity range of 43% to 21%. CONCLUSIONS: Low-sensitivity thromboplastins may give erroneously high INRs in the upper therapeutic range. Plasma prothrombin times should be done with a high-sensitivity thromboplastin, particularly in patients maintained at the upper limit of the therapeutic range. An INR so obtained correlated well with an INR obtained with a portable capillary blood monitor.

Autoantigens↗
PubMedDate not supplied

Statistical analysis of environmental monitoring data: does a worst case time for monitoring clean rooms exist?

To determine the relationship between the sampling time of the environmental monitoring, i.e., viable counts, in aseptic filling areas and the microbial count and frequency of alerts for air, surface and personnel microbial monitoring, statistical analyses were conducted on 1) the frequency of alerts versus the time of day for routine environmental sampling conducted in calendar year 1994, and 2) environmental monitoring data collected at 30-minute intervals during routine aseptic filling operations over two separate days in four different clean rooms with multiple shifts and equipment set-ups at a parenteral manufacturing facility. Statistical analyses showed, except for one floor location that had significantly higher number of counts but no alert or action level samplings in the first two hours of operation, there was no relationship between the number of counts and the time of sampling. Further studies over a 30-day period at the floor location showed no relationship between time of sampling and microbial counts. The conclusion reached in the study was that there is no worst case time for environmental monitoring at that facility and that sampling any time during the aseptic filling operation will give a satisfactory measure of the microbial cleanliness in the clean room during the set-up and aseptic filling operation.

Drug Industry↗
PubMedDate not supplied

The role of 24-hr gastric pH-monitoring in the interpretation of 24-hr gastric bile monitoring for duodenogastric reflux.

BACKGROUND/AIMS: Duodenogastric reflux is a physiologic phenomenon. For a number of years, alkalinization of the acidic intragastric pH environment, as assessed by 24-hour gastric pH-monitoring, was thought to be caused by duodenogastric reflux. The recent introduction of the fotooptic Bilitec system for intraluminal bilirubin measurement has created the possibility to directly quantify a component of duodenal juice. METHODOLOGY: In this study, 24-hour gastric pH-monitoring and 24-hour bilirubin monitoring were performed in healthy subjects. The upper limits for physiologic bile reflux are the 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). RESULTS: Comparing bile with pH-monitoring (absorbance > 0.25 and/or pH > 4), an increase of bilirubin was found most frequently with constant pH (43%) or an increase of pH with constant bilirubin (37%). CONCLUSIONS: The hypothesis was drawn that the composition of duodenogastric refluxate can vary. Bile and pancreatic juice may separately contribute to duodenogastric reflux.

Bile↗
PubMed2000

Perioperative monitoring with the electroencephalogram and the bispectral index monitor.

Recent clinical studies using the bispectral index monitor to predict movement, measure the level of consciousness, and reduce the cost of anesthesia have renewed interest in the use of a monitor to assess the effects of anesthetics on the brain. In 1937, Gibbs described electroencephalographic changes during the administration of general anesthetics. Artusio in 1954 used unprocessed electroencephalographic waveform analysis during an ether anesthetic to study the first stage of anesthesia. Some of the first automated electroencephalographic processors used power spectrum analysis for assessment of the patient's brain activity during surgery and anesthesia. The purpose of this article is to provide a historical perspective of the development and use of the processed electroencephalographic monitor. This article also describes studies of clinical usefulness of the bispectral index monitoring device in anesthesia practice today.

Anesthesia, General↗
PubMed2001

[Self monitoring versus ambulatory blood pressure monitoring].

Blood pressure is a variable parameter for which the isolated determination cannot be considered as a characteristic of the subject. Therefore, the clinical measurement of blood pressure constitutes the method of reference but presents limits and causes of errors which pose a problem for its validity in evaluating the average blood pressure level in certain patients. In order to overcome the limits of occasional measurement, different methods of blood pressure measurement have been proposed. Among these methods, self monitoring of blood pressure by the patient and 24 hour ambulatory blood pressure monitoring (ABPM) are the most used. Each of these methods presents advantages and disadvantages, indications and limits of use. The information obtained by each of them is of a different nature: these methods are not substitutes but are complementary. Self monitoring and ABPM seem to evaluate the pressure load better than clinical monitoring and are better correlated to the organic effects of hypertension and thus the cardiovascular morbidity and mortality, ABPM in particular. However, it remains to be clarified whether the use of these methods in the evaluation of cardiovascular risk and the therapeutic management of the hypertensive can improve the long term cardiovascular prognosis.

Blood Pressure↗
PubMed1992

[Role of home monitoring in the context of sudden infant death prevention. Current methods indications, monitoring].

Some infants are cared with a home monitoring system during their first year of life. An international clinical consensus has been obtained and has proposed this technique mainly for infants who have presented an apparent life threatening event or for ex-premature with bradycardia or apnea, rather than for siblings of sudden infant death syndrome or other infants. In any case, this monitoring must be held after a complete clinical evaluation of the infant and after a real education of the parents about the use of the device. Many types of devices are used. The most efficient is the cardio-respiratory monitoring. Some of them include a processor and record the alarms. The need to see or to call the medical team to decode them allows close collaboration between the family and the clinical team. Knowledge of the alarms and the circumstances in which they have occurred help the medical team to propose the withdrawal of the home monitoring. Thus, sometimes preventive, sometimes prophylactic, this device will provide us for an optimal help.

Heart Function Tests↗
PubMedDate not supplied

[Monitoring of clinical trials and interim analysis. 1. Monitoring committee].

In order to fulfil the ethical principles linked to the protection of patients randomized in a controlled clinical trial, monitoring procedures need to be set up. In this context, a committee of experts, called the data monitoring committee is in charge of reviewing regularly unblinded data to assess the quality and the relevance of the trial, to evaluate the evidence of an emerging treatment difference and to control the rate of occurrence of serious adverse events. After each meeting, the monitoring committee reports to the steering committee its recommendation to continue or to stop the trial prematurely. Protocol modifications might be proposed as well. Illustrated with several examples, this article reviews different situations a monitoring committee might have to tackle with.

Clinical Protocols↗
PubMed2004

[New monitoring method for the pudental nerve during surgery: cases of intraoperative monitoring for lumbo-sacral lipomeningocele].

We carried out intraoperative monitoring of the pudental nerve while separating vertebral spinal tumors from the spinal cord in five patients, including four infants. Although monitoring using a manometer or needle electrodes has been reported, monitoring done with disk electrodes to ascertain the compound muscle action potential (CMAP) of the external sphincter muscle has not been yet attempted. Prior to the surgical procedure, we locate a point suitable for CAMP recording of the muscle. In our recent study, we determined that maximum action potentials were recorded in the part with the greatest depth from the individual anal verge. Therefore, the depth of the anal canal was preoperatively measured for the manometry method, and sphincter electrodes currently on the market were refigured to suit the infant's anal canal. After the two procedures described above, we were able to preserve the pudental nerves intraoperatively. The postoperative neurological findings of all five patients were unchanged. We introduce here this new method of intraoperative monitoring for preserving the pudental nerve.

Action Potentials↗
PubMed2005

Is non-invasive monitoring of intracranial pressure waveform analysis possible? Preliminary results of a comparative study of non-invasive vs. invasive intracranial slow-wave waveform analysis monitoring in patients with traumatic brain injury.

BACKGROUND: An increasing body of evidence supports the concept that intracranial pressure (ICP) slow B waves represent the auto-regulatory response of spontaneous fluctuations of cerebral perfusion pressure. A relationship between cerebral auto-regulation and clinical outcome in patients with traumatic brain injury has also been established. The objective of our prospective clinical study was to compare the B slow ICP waves obtained invasively by standard ICP monitoring to those obtained noninvasively using a new ultrasound technology. MATERIAL/METHODS: In the participating institutions, over a period of six months, thirteen consecutive patients (8 males and 5 females) with severe closed head injuries (GCS < 8) were included in our IRB-approved study. Intracranial pressure and B slow waves, as well as arterial blood pressure and waveforms, were evaluated by standard invasive techniques. Additionally, a new non-invasive ultrasound device, Vittamed (Telematics Scientific Laboratory, Kaunas, Lithuania), was employed for monitoring intracranial blood volume slow waves. Using these modalities, it was possible to compare the changes that occurred with invasive monitoring (Correlation factor RI) and the changes that occurred using non-invasive technology (Correlation factor RN). RESULTS: Bland Altman plot analysis showed positive correlation between the invasively and non-invasively obtained slow intracranial B waves (2sigma = 8.9%, p < 0.0001) and cerebral auto-regulation indexes (RI and RN) (SD = 5%, p < 0.0001). Positive RI and RN values were correlated with poor clinical outcome. CONCLUSIONS: Ultrasonographic technology (Vittamed) may have significant application in non-invasive continuous cerebrovascular auto-regulation monitoring in patients with severe head injuries.

Adolescent↗
PubMed2005

[Reinvestigation of CSF outflow resistance value in idiopathic normal pressure hydrocephalus--comparing epidural pressure monitoring with lumbar subarachnoid cerebrospinal fluid pressure monitoring].

PURPOSE: To compare the cerebrospinal fluid (CSF) outflow resistance values (Ro) with epidural pressure (EDP) monitoring and lumbar subarachnoid CSF pressure (L-CSFP) monitoring. SUBJECTS AND METHODS: The subjects were 14 patients with possible iNPH (age: 59-74 years old, ratio of male and female 8:6). All the patients were subjected to an infusion test by a single bolus injection method (1 ml/sec., deltaV: 5 ml, t2: 2 min) as prescribed in the Standard of SINPHONI. EDP was monitored by continuous monitoring and the L-CSFP values By intermittent simple glass tube method (SINPHONI) were measured simultaneously. The Ro (RoEDP, RoL-CSFP) calculated from both methods, (1) the correlation of Ro and (2) the Ro threshold in a shunt effective group (E: nine cases) and a non effective group (NE, five cases) were compared. RESULTS: (1) Although a favorable correlation was found between both Ro measurements (r=0.784), the RoEDP was always higher than the RoL-CSFP. (2) The mean Ro values in the E and NE groups were 36.8 +/- 15.7 mmHg/ml/min, and 10 +/- 2.05 mmHg/ml/min for Ro-EDP, 22.1 +/- 13.95 mmg/ml/min and 6.4 +/- 1.7 mmHg/ml/min for RoL-CSFP, respectively. The approximate thresholds in the E and NE groups were 15 mmHg/ml/min for RoEDP and 10 mmHg/ml/min for RoL-CSFP. CONCLUSION: (1) Although the RoEDP is always higher than the RoL-CSFP, a favorable correlation is found between the RoEDP and RoL-CSFP, (2) The Ro thresholds of the E and NE groups in the infusion test are about 15 mmHg/ml/min for RoEDP and 10 mmHg/ml/min for RoL-CSFP. (3) After this, Ro calculation ought to execute by standard of SINPHONI and the Ro threshold of the E and NE groups is about 10 mmHg/ml/min.

Aged↗
PubMed1991

A flexible system for vital signs monitoring in hospital general care wards based on the integration of UNIX-based workstations, standard networks and portable vital signs monitors.

The article describes a study conducted on general surgical and thoracic surgical floors of a 1000-bed hospital to assess the impact of a new network for portable patient care devices. This network was developed to address the needs of hospital patients who need constant, multi-parameter, vital signs surveillance, but do not require intensive nursing care. Bedside wall jacks were linked to UNIX-based workstations using standard digital network hardware, creating a flexible system (for general care floors of the hospital) that allowed the number of monitored locations to increase and decrease as patient census and acuity levels varied. It also allowed the general care floors to provide immediate, centralized vital signs monitoring for patients who unexpectedly became unstable, and permitted portable monitors to travel with patients as they were transferred between hospital departments. A disk-based log within the workstation automatically collected performance data, including patient demographics, monitor alarms, and network status for analysis. The log has allowed the developers to evaluate the use and performance of the system.

Boston↗
PubMed1988

[Evaluation of occupational exposure to inhalation anesthetics. Study Group on Environmental Monitoring, Biological Monitoring and Laboratory Surveillance in Lombardia].

A group of Occupational Medicine researchers in Lombardia prepared a document about the problems of occupational exposure to inhalation anaesthetics referring to the Meeting "Occupational Hazard from Inhalation Anaesthetics. Monitoring and Prevention". (Pavia, May 1988). A survey in 111 operating theatres and 11 hospitals showed high anaesthetics pollution and allowed to find its main causes. On the basis of this survey the authors were able to indicate the methods to control the exposure, both by determining the polluting agents in working environment, and by using the internal dose biological monitoring. For the exposure monitoring the authors suggest determining nitrous oxide (N2O) in various sites of the operating rooms, in the operators respiratory zone and/or in single workers' urine at the end of the work-shift. The environmental and/or biological measurement of nitrous oxide also indicated the pollution due to other inhalation anesthetics used at the same time. The authors also make suggestions about the methods and timing of environmental and biological monitoring and health surveillance.

Air Pollutants, Occupational↗