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Physiologic monitoring systems.

Physiologic monitoring systems monitor vital physiologic parameters so that clinicians can be informed of changes in a patient's condition. They typically consist of several distinct components, including a central station, bedside monitors, and ambulatory telemetry transmitters and receivers. We previously evaluated physiologic monitoring systems in our January-February 1999 issue (Health Devices 28[1-2]). For this update, we have tested systems from two additional suppliers, using the same criteria and test methods that we used for the eight systems in the original study. As in the earlier Evaluation, we have examined how each system functions as a whole, rather than focusing on the performance of individual components. We judged the systems primarily on adaptability, alarm implementation, and human factors design. In the Conclusions, we compare all 10 units evaluated to date. We also provide updated product information for the systems evaluated in our original study; in some cases, the changes that have been made to those systems have caused us to revise our ratings. We rated all the systems based on their capabilities for each of six applications: (1) critical care unit, (2) emergency department, (3) intermediate care unit and general medical/surgical floor, (4) operating room, (5) postanesthesia care unit, and (6) transport. As in our earlier study, we have determined that most of the evaluated systems have drawbacks for one or more of the evaluated applications. In our January-February 1999 Evaluation of physiologic monitoring systems (Health Devices 28[1-2]), we discussed the issues surrounding the purchase and use of these systems. In this introduction, we recap the most significant points from that discussion, provide some new information about ambulatory telemetry and wireless networks, and briefly describe the components of this Update Evaluation.

Equipment Design↗

Physiologic monitoring systems.

Physiologic monitoring systems monitor vital physiologic parameters so that clinicians can be informed of changes in a patient's condition. For this study, we evaluated systems from six monitoring suppliers--Dräger Medical, GE Healthcare, Nihon Kohden, Philips Medical Systems, Spacelabs Medical, and Welch Allyn. The intent of this study is to help facilities choose not just the most appropriate system, but also the most appropriate version of that system--the combination of components that will best suit the facility's needs. Our testing focused primarily on adaptability, alarm implementation, and human factors design. We rated the systems based on their capabilities and performance for each of seven care settings: critical care unit, emergency department, intermediate care unit and general medical/surgical floor, operating room (with separate ratings for use during conscious sedation and general anesthesia), postanesthesia care unit, and transport. The systems performed well against the majority of our criteria. Nevertheless, we found notable differences in specific features and performance areas. These differences will have varying levels of significance for different hospitals.

Costs and Cost Analysis↗

Physiologic monitoring systems.

Physiologic monitoring systems, which monitor vital physiologic parameters so that clinicians can be informed of changes in a patient's condition, typically consist of several distinct components, including a central station, bedside monitors, and ambulatory telemetry transmitters and receivers. For this study, rather than focusing on how each component performs individually, we evaluated how the entire system functions as a whole to better parallel the acquisition practices followed by most hospitals. We evaluated systems from eight suppliers, focusing primarily on adaptability, alarm implementation, and human factors design. We included only systems that offer (1) a central station that can concurrently receive information from bedside monitors and ambulatory telemetry transmitters, (2) one or more bedside monitors that can be used in critical care and intermediate care areas, as well as during transport, and (3) ambulatory telemetry monitoring. We rated the evaluated systems based on their capabilities for each of six applications: critical care unit, emergency department, intermediate care unit and general medical/surgical floor, operating room, postanesthesia care unit, and transport. We found that many of the systems are suitable for some applications, but are unable to meet the requirements for others.

Computer Systems↗

Cerebral physiologic monitoring.

Cerebral physiologic monitoring techniques can be categorized into those measuring perfusion, metabolism, and function. The physiologic basis for each of these is outlined, with a description of the clinical methods currently available. The clinical application of each monitoring modality is discussed with special reference to its impact on outcome of the brain-injured patient.

Brain↗

Enhancing patient safety through a standardized model of physiologic monitoring.

The use of physiologic monitoring (e.g., cardiac monitoring) as an important component in providing safe patient care has escalated over the past two decades. It enables the clinician to detect physiologic changes in the patient's condition before they become clinically significant, thus allowing anticipation and prevention of adverse events. Issues and concerns regarding physiologic monitoring were raised throughout the London Health Sciences Centre (LHSC) leading to the approval of a project to develop a policy and guidelines for its use: the focus being standardization of processes and patient safety improvements. This article describes the underlying issues, the execution and results of the project, and its impact on patient safety within LHSC.

Humans↗

[The study of architecture of portable multiparameter physiological monitor].

The portable multiparameter physiological monitor now becomes a hot point of competition of international manufactures. The paper uses the UPM-2001 patient monitor as an example, studies the key points of design of portable-type monitor which breaks through the traditional architecture of desk-type monitor.

Computer Communication Networks↗

Physiological monitoring of cardiorespiratory adaptations during rehearsal and performance of contemporary dance.

Previous research has shown that dance class and rehearsal stress different cardiorespiratory energy systems than dance performance. The aim of the present study was to monitor the physiological parameters of a number of dancers during a 12-week rehearsal period and an 8-week performance schedule. Seventeen dancers (8 men and 9 women) from 2 companies undertook the multistage dance specific aerobic fitness test before the rehearsal period, before the performance period, and after the performance period. Heart rate data were collected throughout the test; the mean heart rate during stage 5 and blood lactate levels were measured at the end of the test. No significant changes in heart rate or lactate parameters were noted between the prerehearsal and preperformance tests, but significant decreases during the preperformance and postperformance tests were shown in both parameters (p < 0.01 and p < 0.01, respectively), which suggests an increase in the subjects' aerobic capacities during the performance period. Implications from the present study suggest that dancers are not adequately physiologically prepared to perform to the same degree to which their skills are honed. The study suggests that supplemental training is required to bridge this physical gap and better prepare the dancer for performance.

Adaptation, Physiological↗

Intraoperative and postoperative physiological monitoring practices by pediatric dentists.

The medical and dental literature has described successful sedations and those which have resulted in injury and death. Physiologic monitoring of patients is essential in assuring the success and safety of sedations in the dental office. The purpose of this study was to investigate the utilization and preferences of various physiologic monitoring methods and utilization of dentist anesthesiologists by pediatric dentists during sedations. Pediatric dentists in California were surveyed [n = 261] regarding monitoring methods in five different case scenarios. The most frequently utilized methods were clinical observation, pulse oximeter, and precordial stethoscope. Eighty seven percent of the pediatric dentists who use sedation do so without the involvement of a dentist anesthesiologist. Eighteen percent of pediatric dentists do not use any sedative agents in their practice. In the five case scenarios described in the survey, clinical observation was the most frequently utilized monitoring method during intra- and postoperative periods, followed by the pulse oximeter and precordial stethoscope. Intra- and postoperative monitoring varied with the complexity of the case scenario and most respondents monitored continuously. The trends observed from this study indicate that recent graduates use more sedative agents and find the pulse oximeter to be useful for physiologic monitoring during sedation.

Adolescent↗

Standards of evidence for the safety and effectiveness of critical care monitoring devices and related interventions. Coalition for Critical Care Excellence: Consensus Conference on Physiologic Monitoring Devices.

OBJECTIVE: To devise alternatives to randomized, controlled, clinical trials that clinicians and research experts might find acceptable for approval of devices used in critical care medicine. DATA SOURCES: The Coalition for Critical Care Excellence (Coalition) of the Society of Critical Care Medicine organized a consensus conference in which recognized critical care researchers gave testimony to a panel of experts regarding the process for testing and approval of monitoring devices. DATA SELECTION: The expert panel used testimony from the presenters as the basis of discussions on the testing and approval process. Guiding principles and specific recommendations were made based on the testimony given. MAIN RESULTS: The panel determined the main constituents of the medical device approval process to be the Food and Drug Administration (FDA), the research and clinical community, and the device manufacturers. Distinctions were made between monitoring and interventional device categories. This document addresses only monitoring devices. Potential alternatives to randomized, blinded, controlled study designs for device testing are: a) nonblinded, randomized, management protocol-driven study; b) crossover study (n-of-one design); c) cluster-randomization (randomized by care unit); d) case-matched controls; e) mixed design; f) on/off design (before-after); and g) historical controls. CONCLUSIONS: The panel agreed on the following major recommendations: a) the FDA should accelerate publication of specific guidances for physiologic monitoring products with the assistance of the Coalition (priorities and content); b) more multidisciplinary research should be incorporated into new device studies; c) commonly accepted clinical tools may not need to be tested for clinical utility--these accepted tools should be identified by the Coalition; and d) an independent council of researchers and clinicians should make themselves available to serve as consultants to manufacturers regarding appropriate study design for the testing of devices.

Case-Control Studies↗

A flexible PC-based physiological monitor for animal experiments.

We have developed a flexible physiological monitoring and analysis system for physiological studies in which data are obtained over extended periods. Our system uses low-cost personal computer hardware to concentrate data from existing multiple monitoring devices. All monitored parameters are displayed on a single screen and recorded in a single file. The system automates the process of physiological record keeping by providing continuous displays of vital signs. In addition, audible and visual alarms are produced when vital signs are outside of acceptable ranges, prompting the experimenter to take corrective actions. The central element of the system is a program running in a dedicated manner on an IBM PC-compatible computer. The program is written in the C language and makes use of a graphics library to display traces and analysis results in real time on any standard display for the PC. This program assigns the analog channels of an A/D board to particular physiological parameters by initially reading a configuration file, which also describes the alarm conditions and analysis routine for each parameter. All hardware specific code is isolated into well-defined modules. The program is both highly flexible with regard to different sets of parameters and highly portable for different experimental and computer environments.

Animals↗

Affective responses to commercial and experimental auditory alarm signals for anaesthesia delivery and physiological monitoring equipment.

The affective response of subjects to the sounds of commercial and experimental auditory alarm signals was tested using a standard experimental protocol for measuring mood states and changes. Both types of signal evoked affective response. The commercial signals, however, evoked more response than the experimental signals, and that response was more negative in affect. A subset of the experimental signals, distinguished by specific acoustic characteristics, evoked particularly low levels of affect. The implications of low-affect alarms for the operating room are discussed.

Adult↗

Physiologic monitoring of circulatory dysfunction in patients with severe head injuries.

Secondary brain insults influence outcome significantly in patients with severe head injuries. Inadequate tissue perfusion should be identified and treated early to avoid such insults. Conventional hemodynamic monitoring (blood pressure, heart rate, urine output) is not a reliable method for evaluating circulatory function in such patients. Invasive monitoring by means of pulmonary artery catheters may offer more precise information on early circulatory abnormalities. The objective of this study was to study the hemodynamic patterns of patients with severe closed head trauma by invasive methods and to correlate the derived information with survival. Fifty-nine consecutive patients with blunt trauma, closed head injuries, and Glascow Coma Scale < 8 were studied. Pulmonary artery catheters were placed in all patients shortly after admission, and flow and flow-derived variables were monitored for 96 hours or patient demise. Survivors had higher cardiac index, oxygen delivery, and oxygen consumption values compared to nonsurvivors during the first 24 hours after injury. Following this period increased values were recorded in both groups. These temporal hemodynamic patterns were similar for patients with isolated head trauma and patients with other associated injuries. Thus initial hemodynamic patterns are associated with final outcome in patients with severe head injuries. Aggressive early hemodynamic monitoring may reveal subtle but significant changes. Further studies are warranted to investigate whether treatment guided by such information can improve survival.

Adult↗

Evaluation of the right atrial venous oxygen saturation as a physiologic monitor in a neonatal model.

Pulmonary artery (PA) mixed venous saturation (SvO2) has become a crucial monitor in the adult intensive care unit, but is not used in neonates because of the difficulty in PA catheterization. We evaluated the possibility of utilizing the right atrial venous oxygen saturation (RAvO2), which is easily accessed in the neonate, as a monitor of the effects of mechanical ventilation and intravascular volume in an animal model selected to be the size of the human neonate. A continuous RAvO2 monitoring catheter was placed into the right atrium of 16 normal rabbits (2.2 to 4.1 kg). Oxygen delivery was manipulated by alterations in peak inspiratory pressure (PIP) (n = 6), positive end-expiratory pressure (PEEP) (n = 6), or by progressive hypovolemia (n = 4). RAvO2 decreased with onset of mechanical ventilation alone from 69% +/- 6% to 61% +/- 5% (P < .01). As the PIP was increased from 12 to 21 cm H2O, the RAvO2 progressively decreased from 59% +/- 4% to 49% +/- 6% (P < .05). As the PEEP was increased from 3 to 9 cm H2O, the RAvO2 progressively decreased from 64% +/- 5% to 33% +/- 16% (P < .01). RAvO2 approached baseline after return to continuous positive airway pressure (CPAP) of 3 cm H2O. Progressive phlebotomy to a total of 10 mL/kg resulted in a decrease in RAvO2 from 70% +/- 6% to 27% +/- 5% (P < .001). Volume resuscitation resulted in an increase in RAvO2 to near baseline. Peripheral arterial oxygen saturation remained at a constant 100% throughout each protocol.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

A study of VitalView for behavioural and physiological monitoring in laboratory rats.

We describe the use of a commercially available telemetry and data acquisition system to record heart rate, body temperature and activity of freely behaving rats with transmitters that operate without batteries (transponders). The system uses PDT 4000HR E-Mitters (Mini Mitter, OR, USA) to acquire animal temperature, heart rate and motor activity data. E-Mitters obtain power from a radiofrequency field produced by an ER-4000 energizer/receiver so that transponders can collect data on heart rate, body temperature and gross motor activity. ER-4000 energizers/receivers are designed to be placed below the animals' cage. Data output from receivers is managed by a Windows PC-based data acquisition system, VitalView. In this study, we report that a good correlation exists between VitalView and Powerlab for the determination of heart rate and between intra-abdominal (telemetric) and colonic body temperature (rectal digital thermometer) in rats. Assessment of this system by using agents that have well-documented effects on heart rate, body temperature and locomotor activity have also been determined. An additional feature of VitalView is the incorporation of behavioural inputs (feeding monitors to monitor duration and frequency of feeding and a lickometer to monitor drinking bouts) into the data acquisition system designed primarily to acquire data from the implanted transponders. Circadian rhythms for all parameters were established in rats with E-Mitters implanted. VitalView may be used for the determination of multiple parameters in freely behaving animals using transponders, which operate without batteries. This capability is unique in its field and represents a recent advance in biotelemetric monitoring of laboratory animals.

Animals↗