Biomedical subjects

L A Eidelman

Publications and source records attributed to L A Eidelman.

At least 19 recordsLinked to original sources

PubMed2003

Nausea and vomiting after fast-track cardiac anaesthesia.

BACKGROUND: The aim of this study was to determine the prevalence of postoperative nausea and vomiting (PONV) after fast-track cardiac anaesthesia, risk factors for PONV and its influence on the length of stay in the intensive care unit (ICU). METHODS: A prospective study was performed in the cardiothoracic ICU (CTICU) of a university hospital; 1221 consecutive patients undergoing fast-track anaesthesia (FTCA) in cardiac surgery were enrolled in the study. Severity of PONV was assessed immediately after extubation and then every hour until discharge from the CTICU. Metoclopramide 10 mg i.v. was used as a first-line rescue medication and ondansetron 4 mg i.v. as second-line rescue medication for PONV. RESULTS: Nausea was reported in 240 (19.7%) patients, and vomiting in 53 (4.3%). A total of 269 (22%) patients were treated with metoclopramide and 38 (3.1%) with metoclopramide and ondansetron. The latter was effective in all cases. Risk factors for PONV were age less than 60 yr, female gender and previous history of PONV. Discharge from the CTICU was delayed for a few hours because of PONV in eight patients, all of whom were discharged the same day. CONCLUSIONS: The incidence of PONV is relatively low after FTCA and does not prolong ICU stay. Prophylactic administration of anti-emetic drugs before FTCA is not necessary.

Adult↗

PubMed2000

Computer assisted physiologic monitoring and stability assessment in vascular surgical patients undergoing general anesthesia--preliminary data.

BACKGROUND: Physiologic monitors present an influx of numerical data that can be overwhelming to the clinician. We combined several parameters in an effort to reduce the amount of information that must be continuously monitored including oxyhemoglobin saturation by pulse oximetry, end-tidal CO2 concentration, arterial blood pressure, and heart rate into an integrated measure--the health stability magnitude (HSM). The HSM is computed for a predetermined basal period, the reference HSM (RHSM), and recalculated continuously for comparison with the baseline value. In this study we present the HSM concept and examine changes in the HSM during abdominal aortic aneurysm surgery. MATERIALS AND METHODS: After IRB approval, nine patients were studied. The anesthesiologist recorded all significant intra-operative events. Within a defined time interval, data were recorded and used to calculate a combined parameter, the HSM. The baseline or reference value of this index (RHSM) was calculated after the induction of anesthesia. Individual HSM values were repeatedly calculated for ten second periods after the RHSM value was established. A > 30% deviation of the HSM from the RHSM was considered significant. Deviations in the HSM were compared with events recorded by the anesthesiologist on a paper record and with the record from an electronic record-keeping system. The deviation observed between two consecutive HSMs, called dHSM, was plotted against HSM to construct a contour diagram of data from all patients to which individual cases could be compared. RESULTS: The plot showed that dHSM vs. HSM values were tightly clustered. The inner contour on the distribution plot contained 90% of values. Individual patient's time course, projected on this diagram, revealed deviations form "normal" physiology. Fifty-nine events led to > 30% deviations in the HSM; 27 were anticipated events and 32 were unanticipated. CONCLUSION: The correlation between HSM and dHSM depicts changes in multiple monitored parameters that can be viewed using a single graphical representation. Projection of individual cases on the contour diagram may help the clinician to distinguish relative intraoperative stability from important events. Data reduction in this manner may guide clinical decision-making in response to unanticipated or unrecognized events.

Aged↗

PubMed1999

Spontaneous intracerebral hemorrhage in critically ill patients: incidence over six years and associated factors.

OBJECTIVE: Intracerebral hemorrhage (ICH) is associated with a high mortality. The present study sought to determine the incidence of spontaneous ICH in an intensive care unit (ICU) and associated factors. DESIGN: A 6 year retrospective study. SETTING: A general ICU in a university hospital. PATIENTS: All ICU patients developing ICH were included in the study. All trauma and neurosurgical patients were excluded, as well as patients who were admitted to the ICU because of ICH. MEASUREMENTS AND RESULTS: During the study period 3032 patients were hospitalized in the ICU, and 834 were excluded. The remaining 2198 patients comprised the study population. Computed tomography of the head was performed in a total of 227 patients, and the 9 patients found to have new onset ICH comprise the group of interest. None of these patients were hypertensive. Seven of the patients had either a primary hematologic malignancy or bone marrow transplantation. Eight had thrombocytopenia of <100x10(9)/l (median 10x10(9)/l, range 3-150x10(9)/l), and in 6 it preceded ICH by 5 days or more. Only in one patient were both PTT and PT prolonged. All were mechanically ventilated with high peak inspiratory pressure (PIP) (median 37 cm H2O, range 20-43 cm H2O). Arterial carbon dioxide tension (PaCO2) was considerably elevated (median 65 mm Hg, range 41-87 mm Hg). All of the patients had impaired renal and hepatic function (urea: median 14 mmol/l, range 9.9-52 mmol/l; bilirubin: median 94 micromol/l, range 20-360 micromol/l), and five had septicemia. Eight of the patients bled to other sites before they developed ICH. All patients died shortly after the diagnosis of ICH. CONCLUSIONS: Spontaneous nonhypertensive ICH is a rare, fatal event in the ICU. Associated factors include thrombocytopenia, the need for mechanical ventilation, elevated PIP and PaCO2, sepsis, and impaired hepatic and renal function.

APACHE↗

PubMed1999

Laparoscopic extraperitoneal inguinal hernia repair with spinal anesthesia and nitrous oxide insufflation.

BACKGROUND: Laparoscopic repair of inguinal hernia is traditionally performed under general anesthesia mainly because of the adverse effects that carbon dioxide pneumoperitoneum has on awake patients. Since a mandatory use of general anesthesia for all hernia repairs is questionable, the feasibility of laparoscopic extraperitoneal herniorraphy using spinal anesthesia combined with nitrous oxide insufflation was investigated. METHODS: Over a 4-month period, February to May 1998, we performed 35 consecutive total extraperitoneal inguinal hernia procedures (24 unilateral, 11 bilateral) using spinal anesthesia and nitrous oxide extraperitoneal gas. Data on operative findings, self-reported operative and postoperative pain and discomfort (visual analog pain scale), procedure-related hemodynamics, and complications were collected prospectively. RESULTS: All 35 procedures were completed laparoscopically without the need to convert to general anesthesia. Mean operative time was 39 +/- 7 min for unilateral hernia and 65 +/- 10 min for bilateral hernia. Incidental peritoneal tears occurred in 22 patients (63%) resulting in nitrous oxide pneumoperitoneum, which was well tolerated. The patients remained hemodynamically stable throughout the procedure, and operative conditions and visibility were excellent. Complications at a mean of 4 months after the procedure included seven uninfected seromas (20%), three patients with transient testicular pain, and one (3%) recurrence. CONCLUSIONS: Laparoscopic total extraperitoneal hernia repair can be safely and comfortably performed using spinal anesthesia with extraperitoneal nitrous oxide insufflation gas. This method provides a good alternative to general anesthesia.

Aged↗

PubMed1999

Effect of haemofiltration on pathological fibrinolysis due to severe sepsis: a case report.

Bleeding due to coagulopathy is a frequent complication of severe sepsis, especially in burn patients. The primary treatment is aimed at the underlying cause but additional supportive measures, consisting mainly of coagulation factor replacement, are frequently necessary. We describe the salutary effect of continuous veno-venous haemofiltration (CVVH) with predilution on diffuse haemorrhage in a patient with severe septic shock and renal failure. The diffuse haemorrhage was initially treated with replacement of coagulation factors. Prothrombin time and partial thromboplastin time became normal while diffuse bleeding continued and the thrombelastogram showed evidence of fibrinolysis. A short period of CVVH lead to the cessation of bleeding which was reflected by a normal thrombelastogram.

Acute Kidney Injury↗

PubMed1999

Pulse oximetry plethysmographic waveform during changes in blood volume.

Systolic pressure variation (SPV) and its dDown component have been shown to be sensitive factors in estimating intravascular volume in patients undergoing mechanical ventilation. In this study, ventilation-induced changes in pulse oximeter plethysmographic waveform were evaluated after removal and after reinfusion of 10% estimated blood volume. The plethysmographic waveform variation (SPVplet) was measured as the difference between maximal and minimal peaks of waveform during the ventilatory cycle, and expressed as a percentage of the signal amplitude during apnoea. dUp(plet) and dDown(plet) were measured as the distance between the apnoeic plateau and the maximal or minimal plethysmographic systolic waveform, respectively. Intravascular volume was changed by removal of 10% of estimated blood volume and followed by equal volume replacement with Haemaccel. A 10% decrease in blood volume increased SPVplet from mean 17.0 (SD 11.8)% to 31.6 (28.0)% (P = 0.005) and dDown(plet) from 8.7 (5.1)% to 20.5 (12.9)% (P = 0.0005) compared with baseline. Changes in plethysmographic waveform correlated with changes in arterial SPV and dDown (r = 0.85; P = 0.0009). In the absence of invasive arterial pressure monitoring, ventilation-induced waveform variability of the plethysmographic signal measured from pulse oximetry is a useful tool in the detection of mild hypovolaemia.

Adolescent↗

PubMed1999

Evaluation of triage decisions for intensive care admission.

OBJECTIVE: To assess physician decision-making in triage for intensive care and how judgments impact on patient survival. DESIGN: Prospective, descriptive study. SETTING: General intensive care unit, university medical center. INTERVENTIONS: All patients triaged for admission to a general intensive care unit were studied. Information was collected for the patient's age, diagnoses, surgical status, admission purpose, Acute Physiology and Chronic Health Evaluation (APACHE) II score, and mortality. The number of available beds at the time of triage and reasons for refused admission were obtained. MEASUREMENTS AND MAIN RESULTS: Of 382 patients, 290 were admitted, 92 (24%) were refused admission, and 31 were admitted at a later time. Differences between admission diagnoses were found between patients admitted or not admitted (p < .001). Patients refused admission had higher APACHE II scores (15.6+/-1.5 admitted later and 15.8+/-1.4 never admitted) than did admitted patients (12.1+/-.4; p < .001). The frequency of admitting patients decreased when the intensive care unit was full (p < .001). Multivariate analysis revealed that triage to intensive care correlated with age, a full unit, surgical status, and diagnoses. Hospital mortality was lower in admitted (14%) than in refused patients (36% admitted later and 46% never admitted; p < .01) and in admitted patients with APACHE II scores of 11 to 20 (p = .02). The 28-day survival of patients was greater for admitted patients compared with patients never admitted (p = .01). CONCLUSIONS: Physicians triage patients to intensive care based on the number of beds available, the admission diagnosis, severity of disease, age, and operative status. Admitting patients to intensive care is associated with a lower mortality rate, especially in patients with APACHE scores of 11 to 20.

APACHE↗

PubMed1999

Blast lung injury from an explosion on a civilian bus.

OBJECTIVE: To assess clinical signs and management of primary blast lung injury (BLI) from explosions in an enclosed space and to propose a BLI severity scoring system. DESIGN: Retrospective analysis. PATIENTS: Fifteen patients with primary BLI resulting from explosions on two civilian buses in 1996. RESULTS: Ten patients were extremely hypoxemic on admission (PaO2 < 65 mm Hg with oxygen supplementation). Four patients remained severely hypoxemic (PaO2/fraction of inspired oxygen (FIO2) ratio of < 60 mm Hg) after mechanical ventilation was established and pneumothoraces were drained. Initial chest radiographs revealed bilateral lung opacities of various sizes in 12 patients (80%). Seven patients (47%) had bilateral pneumothoraces and two patients had a unilateral pneumothorax. Five (33%) had clinically significant bronchopleural fistulae. After clinical and laboratory data were collected, a BLI severity score was defined based on hypoxemia (PaO2/FIO2 ratio), chest radiographic abnormalities, and barotrauma. Severe BLI was defined as a PaO2/FIO2 ratio of < 60 mm Hg, bilateral lung infiltrates, and bronchopleural fistula; moderate BLI as a PaO2/FIO2 ratio of 60 to 200 mm Hg and diffuse (bilateral/unilateral) lung infiltrates with or without pneumothorax; and mild BLI as a PaO2/FIO2 ratio of > 200, localized lung infiltrates, and no pneumothorax. Five patients developed ARDS with Murray scores > 2.5. Respiratory management included positive pressure ventilation in the majority of the patients and unconventional methods (ie, high-frequency jet ventilation, independent lung ventilation, nitric oxide, and extracorporeal membrane oxygenation) in patients with severe BLI. Of the four patients who had severe BLI, three died. All six patients with moderate BLI survived, and four of five with mild BLI survived (one with head injury died). CONCLUSIONS: BLI can cause severe hypoxemia, which can be improved significantly with aggressive treatment. The lung damage may be accurately estimated in the early hours after injury. The BLI severity score may be helpful in determining patient management and prediction of final outcome.

Adolescent↗

PubMed1998

Foregoing life-sustaining treatment in an Israeli ICU.

OBJECTIVE: To determine whether physicians in Israel withhold and/or withdraw life-sustaining treatments. DESIGN: A prospective, descriptive study of consecutively admitted patients. Patients were prospectively evaluated for diagnoses, types and reasons for foregoing life-sustaining treatment, mortality and times from foregoing therapy until mortality. SETTING: A general intensive care unit of a university hospital in Israel. RESULTS: Foregoing life-sustaining treatment occurred in 52 (13.5%) of 385 patients admitted and 5 (1%) had cardiopulmonary resuscitation. Withholding therapy occurred in 48 patients. Four patients with brain death had all treatments withdrawn. No patient had antibiotics, nutrition or fluids withheld or withdrawn. Time from foregoing therapy until death was 2.9 +/- 0.6 days. Thirty-one of 48 (65%) patients who had therapy withheld died within 48 h. CONCLUSIONS: Withholding life-prolonging treatments is common in an Israeli intensive care unit whereas withdrawing therapy is limited to brain dead patients. Terminal patients die soon after withholding, even if the therapy is not withdrawn. Withholding treatments should be an option for patients and professionals who object to withdrawing therapies.

Ethics, Medical↗

PubMed1998

Systolic pressure variation predicts the response to acute blood loss.

STUDY OBJECTIVE: To evaluate systolic pressure variation (SPV), defined as the difference between the maximum and minimum systolic blood pressure measured during a controlled mechanical respiratory cycle, as a predictor of the cardiac output (CO) response to an acute decrease in ventricular preload. DESIGN: Prospective study with each subject serving as his or her own control. SETTING: Cardiac surgery operating rooms of a university medical center. PATIENTS: 15 adults with good ventricular function undergoing coronary artery bypass grafting. INTERVENTION: During stable anesthetic conditions and before surgical stimulation, 500 ml of blood was removed from each patient over 10 minutes. MEASUREMENTS AND MAIN RESULTS: CO, central venous pressure (CVP), pulmonary artery diastolic pressure, and pulmonary artery occlusion pressure (PAOP), and SPV before and after phlebotomy were recorded. Phlebotomy was associated with significant decreases in CVP, PAOP, and CO, and an increase in SPV. Of these variables, SPV was the best predictor of the percent decrease in CO resulting from blood loss. CONCLUSION: SPV is a dynamic measurement, which, by revealing the response to small cyclical changes in left ventricular preload that occur during the controlled mechanical respiratory cycle, is a better predictor than central filling pressures of the response of CO to acute decreases in preload that occur as a result of acute blood loss.

Acute Disease↗

PubMed1998

Helium versus oxygen for tracheal gas insufflation during mechanical ventilation.

OBJECTIVE: To evaluate and compare the effect of tracheal gas insufflation using two gases with different physical properties, helium and oxygen, as an adjunct to conventional mechanical ventilation in patients with respiratory failure. DESIGN: Prospective, intervention study. SETTING: General intensive care unit in a tertiary university medical center. PATIENTS: Seven sedated and paralyzed patients with respiratory failure of various etiologies. All patients were ventilated in the volume-control mode (tidal volume 5 to 7 mL/kg). Inclusion criteria were PaCO2 of > or =50 torr (> or =6.7 kPa), together with peak inspiratory pressure of > or =35 cm H2O and respiratory rate of > or =14 breaths/min. INTERVENTIONS: All patients were intubated with an endotracheal tube that had an additional lumen opening at its distal end, through which tracheal gas insufflation was administered. The tracheal gas insufflation was applied continuously throughout the respiratory cycle at three flow rates (2, 4, and 6 L/min) with two gases, oxygen and helium, while the ventilatory settings were maintained constant. MEASUREMENTS AND MAIN RESULTS: In addition to airway pressures and arterial blood gases, the relative efficacy of tracheal gas insufflation with each gas was estimated using a "coefficient of efficiency" (which we defined as the change in PaCO2/peak inspiratory pressure) compared with baseline measurements. Tracheal gas insufflation with both gases decreased PaCO2 significantly (p < .05) at all flow rates. This effect was accompanied by an increase in airway pressure with both gases (oxygen and helium). However, at flow rates of 6 L/min, tracheal gas insufflation with helium resulted in lower peak inspiratory pressure than with oxygen. Tracheal gas insufflation with helium was more effective (as estimated by the coefficient of efficiency) than with oxygen at all flow rates (p < .05). CONCLUSION: In volume-controlled, mechanically ventilated patients with respiratory failure, tracheal gas insufflation with helium might be suggested as an alternative to oxygen.

Acute Disease↗

PubMed1997

Continuous spinal anaesthesia using a standard epidural set for extracorporeal shockwave lithotripsy.

PURPOSE: Continuous spinal anaesthesia (CSA) offers considerable advantages over "single shot" spinal or epidural anaesthesia since it allows titration of anaesthesia using small doses of local anaesthetics (LA). We evaluated the feasibility of CSA using a standard epidural set for extracorporeal shockwave lithotripsy (ESWL). METHODS: Charts of 100 consecutive CSAs for ESWL were retrospectively reviewed. Lumbar CSA was performed using a 20G epidural catheter through an 18G Tuohy needle. The CSA was preplanned, or followed inadvertent dural puncture. Small LA boluses were injected to achieve the desired sensory level of anaesthesia. Demographic data, anaesthetic duration, LA doses, the most cephalad sensory level to pinprick, arterial blood pressure, heart rate, use of systemic sympathomimetics and complications were recorded. RESULTS: Mean age was 66.2 +/- 9.9 (SD). The ASA status was III-IV in 54.1% and 5.5% of the preplanned and inadvertent patients, respectively. In 85 anaesthetics, hyperbaric bupivacaine 0.1% (9.7 +/- 7.5 mg) was used as the sole anaesthetic. Sensory level was T4-T8. Maximal decrease in systolic and diastolic blood pressures and heart rate was 19.0 +/- 9.8%, 13.4 +/- 13.3%, and 7.2 +/- 11.7 respectively. Intravenous sympathomimetics were used in nine of 82 (11.0%) preplanned, and in six of 18 (33.3%) inadvertent anaesthetics. Post dural puncture headache appeared following two of 82 (2.5%) preplanned, and four of 18 (22.2%) inadvertent anaesthetics. No postanaesthetic neurological deficit was detected. CONCLUSION: Continuous spinal anaesthesia, using a standard epidural set and hyperbaric bupivacaine is feasible for ESWL in high risk patients. Inadvertent dural puncture does not preclude CSA under these circumstances.

Aged↗

PubMed1997

Legionnaire's disease during pregnancy: a case presentation and review of the literature.

Acute pneumonia complicating pregnancy can have serious consequences for both the mother and the fetus. Streptococcus pneumoniae remains the most common bacterial pathogen, but Legionella pneumophila must be considered as well, especially in severe multisystem disease. With severe disease, premature delivery may occur as has been described in the only previous report of Legionnaire's disease during pregnancy. We present here the first report of Legionnaire's disease in pregnancy, resulting in the term delivery of a healthy infant. Also presented is an extensive review of the literature.

Adult↗

PubMed1997

Perioperative ischemia and cardiac complications in major vascular surgery: importance of the preoperative twelve-lead electrocardiogram.

PURPOSE: To investigate the associations between specific preoperative 12-lead electrocardiogram (ECG) abnormalities, perioperative ischemia, and postoperative myocardial infarction or cardiac death in major vascular surgery. METHODS: Two prospective studies on perioperative myocardial ischemia performed in two tertiary university hospitals were combined to include 405 patients. All preoperative ECGs were analyzed according to the Sokolow-Lyon criteria for left ventricular hypertrophy by investigators who were blinded to the patients' perioperative clinical course. Perioperative myocardial ischemia was detected by continuous ECG recording, and postoperative cardiac complications included myocardial infarction and cardiac death. RESULTS: A total of 19 postoperative cardiac complications occurred (two cardiac deaths and 17 myocardial infarctions). Voltage criteria for left ventricular hypertrophy (78 patients, 19%) and ST segment depression greater than 0.5 mm (98 patients, 24.2%) on preoperative ECGs were both significantly associated with postoperative myocardial infarction or cardiac death (odds ratio, 4.2 and 4.7; p = 0.001 and 0.0005, respectively) and with longer intraoperative and postoperative myocardial ischemia. In each of the two study groups, a preoperative ECG abnormality that involved voltage criteria, ST segment depression, or both (134 patients, 33.1%) was more predictive of postoperative cardiac complications than any other preoperative clinical variable, including a history of myocardial infarction or angina pectoris, diabetes mellitus, pathologic Q-wave by ECG, or preoperative myocardial ischemia. The combined duration of intraoperative and postoperative ischemia and the preoperative ECG with either voltage criteria or ST segment depression were the only independent factors associated with adverse cardiac events by multivariate analysis (p < or = 0.0001 and p = 0.02, respectively). CONCLUSION: Left ventricular hypertrophy and ST segment depression on preoperative 12-lead ECGs are important markers of increased risk for myocardial infarction or cardiac death after major vascular surgery.

Aged↗

PubMed1997

Influence of alterations in foregoing life-sustaining treatment practices on a clinical sepsis trial. The HA-1A Sepsis Study Group.

OBJECTIVES: To evaluate the timing of foregoing life-sustaining treatments in patients enrolled in a sepsis trial and to determine their influence on patient outcome and trial results. DESIGN: Subset of patients in a prospective, randomized, double-blind, placebo-controlled study. SETTING: Twenty-three academic medical centers. PATIENTS: Enrolled patients who had life-sustaining therapies withheld or withdrawn. MEASUREMENTS AND MAIN RESULTS: The number of patients, types of disorders and interventions, reasons, and timing of withholding and withdrawing life-sustaining treatments and their effect on mortality and trial results were assessed. Foregoing of life-sustaining therapies took place in 117 (22%) of 543 patients and occurred within 72 hrs of study drug administration in 38 (32%) patients. Withholding treatment (60%) was more common than withdrawing treatment (40%), but withdrawing treatment was more frequent (51%) than withholding treatment (20%) in the first 72 hrs of the trial (p < .01). Sixty-one (52%) patients had severe underlying disorders with a poor prognosis. The hospital mortality rate was 94% (of the 117 patients). The mean time (SEM) from withholding or withdrawing of treatment until death was 2.83 +/- 0.57 and 0.32 +/- 0.13 days, respectively (p < .001). Patients who had therapies foregone in the first 24, 48, and 72 hrs after receiving the study drug had higher mortality rates in the first 72 hrs (p < .01). CONCLUSIONS: A substantial number of patients enrolled in a sepsis trial had severe underlying diseases and had foregoing of therapies early in the course of the trial, which led to a higher early mortality rate. Enrollment of patients in clinical trials with severe underlying disorders with a high likelihood of having therapies foregone may bias the potential for showing the efficacy of new therapeutic modalities.

Antibodies, Monoclonal↗

PubMed1997

Is the patient's right to die evolving into a duty to die?: Medical decision making and ethical evaluations in health care.

When patient or family requests for continued life-sustaining treatments conflict with doctor recommendations, different conclusions as to what is beneficial for the patient may arise. Past practices usually accepted patient or family requests based on the principle of autonomy or that the doctor's primary responsibility is to the individual patient. Many patients die in intensive care units after doctors forego life-prolonging interventions. Health care changes and cost containment have led to a change in the classical ethical model of the patient-doctor relationship such that concerns for societal requirements increasingly overrule those for individual patient needs. The ability to keep patients alive with little likelihood of recovery and the recognition of escalating health costs have led to calls for the needs of society and distributive justice to be taken into account. A tendency to justify a duty to die for these patients has arisen. Recent legal decisions in cases with conflicts between families and health care providers and institutions over foregoing life-sustaining therapies have decided for the families against doctors and hospitals, compelling institutions and their staff to act contrary to their ethical views. Value judgments of doctors are sometimes confused with medical indications for therapy. Doctors have defined therapies as futile or non-beneficial based on their own values and even withdrawn life-sustaining treatments without patient or family input. In some cases, the right to die is leading to the duty to die even against patient or surrogate wishes. Such observations indicate the need for rigorous analyses of medical decision making in this context and for ethical evaluations in health care in general.

Attitude to Death↗

PubMed1997

Ethical issues of clinical trials for the pulmonary artery catheter.

OBJECTIVE: To review the literature addressing ethical issues related to clinical research and the pulmonary artery catheter (PAC). DATA SOURCE: All pertinent English language articles dealing with ethical issues related to clinical research and the PAC were retrieved from 1970 through 1996. STUDY SELECTION: Articles were chosen for review if ethical issues related to clinical research and the PAC were studied or reviewed. DATA EXTRACTION: From the articles selected, information was obtained about the ethics of clinical research related to the PAC. DATA SYNTHESIS: Many current procedures and treatments used on a daily basis have not been proven effective by clinical trials. Studies showing increased mortality with the use of PACs are worrisome. Many clinicians have strong preferences about the use of PACs for various indications and there have been difficulties performing clinical trials. Clinical equipoise occurs when competent physicians are content to have their patients receive any of the various treatments in a randomized trial because, based on available data, none has proven preferable. Clinical equipoise for pulmonary artery catheterization for various indications is unknown. If >70% of experts determine that pulmonary artery catheterization is indicated or contraindicated for specific indications, clinical equipoise does not exist and a trial could not ethically be performed for these indications. Indications and contraindications for pulmonary artery catheterization for these indications, however, should be determined. Clinical equipoise would be present if <70% of experts favor pulmonary artery catheterization for a specific indication and trials could be performed in patients with these disorders. CONCLUSION: Randomized clinical trails of pulmonary artery catheterization can ethically be conducted.

Catheterization, Swan-Ganz↗

PubMed1997

The issue of a U.S. Food and Drug Administration moratorium on the use of the pulmonary artery catheter.

OBJECTIVE: To review the literature addressing the issue of a U.S. Food and Drug Administration (FDA) moratorium on use of the pulmonary artery catheter (PAC). DATA SOURCE: Pertinent English language articles dealing with medical devices including the PAC were retrieved from 1976 through 1996. STUDY SELECTION: Articles were chosen if issues related to medical devices were studied or reviewed. DATA EXTRACTION: From the articles selected, information about the 1976 Medical Device Amendment and the PAC was obtained. DATA SYNTHESIS: In 1976, the Medical Device Amendment gave the FDA power over medical devices. The pulmonary artery catheter is considered a class II device and was on the market before passage of the 1976 Act. Class II devices require general and specific controls to reasonably assure safety and effectiveness. A reasonable assurance of safety occurs when the probable benefits to health from the use of the device outweigh any probable risks. If a monitor measures an established and well-understood variable and the intended use claim is limited to the measurement of that variable, then the effectiveness consists of determining device safety and performance defined as the measurement of agreement with a recognized reference method. Deaths and serious injuries secondary to pulmonary artery catheterization are extremely rare despite more than 25 years of use. Pulmonary artery catheter manufacturer's indications for use are measurements such as hemodynamic pressures, thermodilution cardiac output, continuous cardiac output, mixed venous oxygen saturation, and blood sampling; intended uses have not included claims of clinical benefit. Evidence exists that pulmonary artery catheterization provides agreement with established measurements including pressure and cardiac output. Evidence also exists that pulmonary artery catheter derived data are unobtainable clinically, that the derived data helps in therapy changes and may lead to more appropriate therapy. The evidence demonstrates an absence of unreasonable risk of injury from pulmonary artery catheterization and provision of important clinical results. Therefore, pulmonary artery catheterization meets FDA requirements for safety and effectiveness. CONCLUSION: An FDA moratorium on the use of the PAC is not indicated.

Catheterization, Swan-Ganz↗