Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury. A randomised, controlled trial of the pulmonary artery catheter in critically ill patients. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. Routine pulmonary artery catheterization does not reduce morbidity and mortality of elective vascular surgery: results of a prospective, randomized trial. Comparison of noninvasive positive pressure ventilation with standard medical therapy in hypercapnic acute respiratory failure. Randomized evaluation of pulse oximetry in 20,802 patients: II. Perioperative events and postoperative complications. Costs of an emergency department-based accelerated diagnostic protocol vs hospitalization in patients with chest pain: a randomized controlled trial. Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome: a randomized controlled trial. The impact of continuous pulse oximetry monitoring on intensive care unit admissions from a postsurgical care floor. Hemodynamic and pulmonary changes during open, carbon dioxide pneumoperitoneum and abdominal wall-lifting cholecystectomy. A prospective, randomized study. A prospective randomized trial of preoperative "optimization" of cardiac function in patients undergoing elective peripheral vascular surgery.
Over the past 30 years the pulmonary artery catheter (PAC) has become a widely used haemodynamic monitoring device in the management of critically ill patients, though doubts exist about its safety. Our aim was, therefore, to ascertain whether hospital mortality is reduced in critically ill patients when they are managed with a PAC.
                We did a randomised controlled trial to which we enrolled 1041 patients from 65 UK intensive care units. We assigned individuals to management with (n=519) or without (n=522) a PAC. The timing of insertion and subsequent clinical management were at the discretion of the treating clinician. Intensive care units decided a priori to have the option of using an alternative cardiac output-monitoring device in control patients.
                1014 patients were eligible for analysis. We noted no difference in hospital mortality between patients managed with or without a PAC (68% [346 of 506] vs 66% [333 of 507], p=0.39; adjusted hazard ratio 1.09, 95% CI 0.94-1.27). We noted complications associated with insertion of a PAC in 46 of 486 individuals in whom the device was placed, none of which was fatal.
                Our findings indicate no clear evidence of benefit or harm by managing critically ill patients with a PAC. Efficacy studies are needed to ascertain whether management protocols involving PAC use can result in improved outcomes in specific groups if these devices are not to become a redundant technology. The balance between the benefits and the risks of pulmonary-artery catheters (PACs) has not been established.
                We evaluated the relationship of benefits and risks of PACs in 1000 patients with established acute lung injury in a randomized trial comparing hemodynamic management guided by a PAC with hemodynamic management guided by a central venous catheter (CVC) using an explicit management protocol. Mortality during the first 60 days before discharge home was the primary outcome.
                The groups had similar baseline characteristics. The rates of death during the first 60 days before discharge home were similar in the PAC and CVC groups (27.4 percent and 26.3 percent, respectively; P=0.69; absolute difference, 1.1 percent; 95 percent confidence interval, -4.4 to 6.6 percent), as were the mean (+/-SE) numbers of both ventilator-free days (13.2+/-0.5 and 13.5+/-0.5; P=0.58) and days not spent in the intensive care unit (12.0+/-0.4 and 12.5+/-0.5; P=0.40) to day 28. PAC-guided therapy did not improve these measures for patients in shock at the time of enrollment. There were no significant differences between groups in lung or kidney function, rates of hypotension, ventilator settings, or use of dialysis or vasopressors. Approximately 90 percent of protocol instructions were followed in both groups, with a 1 percent rate of crossover from CVC- to PAC-guided therapy. Fluid balance was similar in the two groups, as was the proportion of instructions given for fluid and diuretics. Dobutamine use was uncommon. The PAC group had approximately twice as many catheter-related complications (predominantly arrhythmias).
                PAC-guided therapy did not improve survival or organ function but was associated with more complications than CVC-guided therapy. These results, when considered with those of previous studies, suggest that the PAC should not be routinely used for the management of acute lung injury. (ClinicalTrials.gov number, NCT00281268.).
                Copyright 2006 Massachusetts Medical Society. To compare the survival and clinical outcomes of critically ill patients treated with the use of a pulmonary artery catheter (PAC) to those treated without the use of a PAC.
                Prospective, randomised, controlled, clinical trial from October 1997 to February 1999.
                Adult intensive care unit at a large teaching hospital.
                Two hundred one critically ill patients were randomised either to a PAC group ( n=95) or the control group ( n=106). One patient in the control group was withdrawn from the study and five patients in the PAC group did not receive a PAC. All participants were available for follow-up.
                Participants were assigned to be managed either with the use of a PAC (PAC group) or without the use of a PAC (control group).
                Survival to 28 days, intensive care and hospital length of stay and organ dysfunction were compared on an intention-to-treat basis and also on a subgroup basis for those participants who successfully received a PAC. RESULTS There was no significant difference in mortality between the PAC group [46/95 (47.9%)] and the control group [50/106 (47.6)] (95% confidence intervals for the difference -13 to 14%, p>0.99). The mortality for participants who had management decisions based on information derived from a PAC was 41/91 (45%, 95% confidence intervals -11 to 16%, p=0.77). The PAC group had significantly more fluids in the first 24 h (4953 (3140, 7000) versus 4292 (2535, 6049) ml) and an increased incidence of renal failure (35 versus 20% of patients at day 3 post randomisation p<0.05) and thrombocytopenia ( p<0.03).
                These results suggest that the PAC is not associated with an increased mortality. Survivors of high-risk surgical operations were previously observed to have significantly higher mean CI, DO2, and VO2 than nonsurvivors. The hypothesis was proposed that increased CI and DO2 are circulatory compensations for increased postoperative metabolism. We tested this hypothesis in two series. In series 1, prospectively allocated by services, mortality and morbidity of the control group were significantly greater than those of the protocol group. In series 2, patients who fulfilled previously defined high-risk criteria were preoperatively randomized to one of three monitoring/treatment groups: CVP-control group, PA-control group and PA-protocol group. Postoperative mortalities in the CVP-control and PA-control groups were not statistically significantly different, but PA-protocol group mortality was significantly reduced compared with its control group. The PA-protocol group had reduced complications, duration of hospitalization, duration in ICU, and mechanical ventilation, and reduced costs when the PA catheter was placed preoperatively and used to augment circulatory responses. To evaluate the routine use of pulmonary artery catheters (PAC) in patients who undergo aortic surgery.
                One hundred twenty patients were randomized to placement of PACs for perioperative monitoring and hemodynamic optimization (tune up) in the intensive care unit on the night before aortic operation, or to intravenous hydration in the ward and perioperative monitoring without PACs. Before randomization, all patients underwent routine adenosine thallium-201 scintigraphy.
                To meet predetermined endpoints, 30 PAC patients (50%) received nitrates, inotropic agents, or both. PAC patients received more fluid in the preoperative period (p < 0.001) and in the first 24 hours after operation (p = 0.002) than control subjects. Eleven PAC patients (18%) and three control subjects (5%) had adverse intraoperative events (p = 0.02). There were 20 adverse postoperative events in 15 PAC patients (25%; nine cardiac, seven pulmonary, four acute tubular necrosis), which was not different compared with 11 postoperative events in 10 control subjects (17%; five cardiac, five pulmonary, one acute tubular necrosis). There were also no differences in duration of mechanical ventilation, intensive care unit stay, or hospital stay between groups. Postoperative cardiac complications were more common among patients who had a history of congestive heart failure (p = 0.02; odds ratio, 3.75; confidence interval, 1.3 to 11) or reperfusion defects on adenosine thallium scintigraphy (p = 0.01; odds ratio, 3.4; confidence interval, 1.2 to 9.4), regardless of group.
                Routine use of PACs for perioperative monitoring with the above protocol during aortic surgery is not beneficial and may be associated with a higher rate of intraoperative complications. Preoperative tune up does not prevent postoperative cardiac, renal, and other complications. Variables such as cardiac risk factors and adenosine thallium scintigraphy may be more important predictors of cardiac events in patients who undergo aortic operations. The authors determined whether the preoperative placement of a pulmonary artery catheter (PAC) with optimization of hemodynamics results in outcome improvement after elective vascular surgery.
                The PAC commonly is used not only in patients who are critically ill, but also perioperatively in major elective surgery. Few prospective studies exist documenting its usefulness.
                One hundred four consecutive patients were randomized to have a PAC placed the morning of operation (group I) or to have a PAC placed only if clinically indicated (group II). Group I patients were resuscitated to preestablished endpoints before surgery and kept at these points both intraoperatively and postoperatively. Group II patients received standard care.
                There was one death in each group. An intraoperative or postoperative complication developed in 13 patients in group I versus 7 patients in group II (p = not significant). Group I patients received more fluid than did group II patients (5137 +/- 315 mL vs. 3789 +/- 306 mL; p < 0.003). There was no significant difference in either overall or surgical intensive care unit length of stay. Only one patient in group II required a postoperative PAC.
                Routine PAC use in elective vascular surgery increases the volume of fluid given to patients without demonstrable improvement in morbidity or mortality. To compare the efficacy of standard medical therapy (ST) and noninvasive mechanical ventilation additional to standard medical therapy in hypercapnic acute respiratory failure (HARF).
                Single center, prospective, randomized, controlled study.
                Pulmonary medicine directed critical care unit in a university hospital.
                Between March 1993 and November 1996, 30 HARF patients were randomized to receive ST or noninvasive positive pressure ventilation (NPPV) in addition to ST.
                NPPV was given with an air-cushioned face via a mechanical ventilator (Puritan Bennett 7200) with initial setting of 5 cm H2O continuous positive airway pressure and 15 cm H2O pressure support.
                At the time of randomization, patients in the ST group had (mean+/-SD) PaO2 of 54+/-13 mm Hg, PaCO2 of 67+/-11 mm Hg, pH of 7.28+/-0.02, and respiratory rate of 35.0+/-5.8 breaths/min. Patients in the NPPV group had PaO2 of 55+/-14, PaCO2 of 69+/-15, pH of 7.27+/-0.07, and respiratory rate of 34.0+/-8.1 breaths/min. With ST, there was significant improvement of only respiratory rate (p < 0.05). However, with NPPV, PaO2 (p < 0.001), PaCO2 (p < 0.001), pH (p < 0.001), and respiratory rate (p < 0.001) improved significantly compared with baseline. Six hours after randomization, pH (p < 0.01) and respiratory rate (p < 0.01) in NPPV patients were significantly better than with ST. Hospital stay for NPPV vs ST patients was, respectively, 11.7+/-3.5 and 14.6+/-4.7 days (p < 0.05). One patient in the NPPV group required invasive mechanical ventilation. The conditions of six patients in the ST group deteriorated and they were switched to NPPV; this was successful in four patients, two failures were invasively ventilated.
                This study suggests that early application of NPPV in HARF patients facilitates improvement, decreases need for invasive mechanical ventilation, and decreases the duration of hospitalization. The authors describe the effect of pulse oximetry monitoring on the frequency of unanticipated perioperative events, changes in patient care, and the rate of postoperative complications in a prospective randomized study.
                The study included 20,802 surgical patients in Denmark randomly assigned to be monitored or not with pulse oximetry in the operating room (OR) and postanesthesia care unit (PACU).
                During anesthesia and in the PACU, significantly more patients in the oximetry group had at least one respiratory event than did the control patients. This was the result of a 19-fold increase in the incidence of diagnosed hypoxemia in the oximetry group than in the control group in both the OR and PACU (P < 0.00001). In the OR, cardiovascular events were observed in a similar number of patients in both groups, except myocardial ischemia (as defined by angina or ST-segment depression), which was detected in 12 patients in the oximetry group and in 26 patients in the control group (P < 0.03). Several changes in PACU care were observed in association with the use of pulse oximetry. These included higher flow rate of supplemental oxygen (P < 0.00001), increased use of supplemental oxygen at discharge (P < 0.00001), and increased use of naloxone (P < 0.02). The rate of changes in patient care as a consequence of the oximetry monitoring increased as the American Society of Anesthesiologists physical status worsened (P < 0.00001). One or more postoperative complications occurred in 10% of the patients in the oximetry group and in 9.4% in the control group (difference not significant). The two groups did not differ significantly in cardiovascular, respiratory, neurologic, or infectious complications. The duration of hospital stay was a median of 5 days in both groups (difference not significant). An equal number of inhospital deaths were registered in the two groups. Questionnaires, completed by the anesthesiologists at the five participating departments, revealed that 18% of the anesthesiologists had experienced a situation in which a pulse oximeter helped to avoid a serious event or complication and that 80% of the anesthesiologists felt more secure when they used a pulse oximeter.
                This study demonstrated that pulse oximetry can improve the anesthesiologist's ability to detect hypoxemia and related events in the OR and PACU and that the use of the oximeter was associated with a significant decrease in the rate of myocardial ischemia. Although monitoring with pulse oximetry prompted a number of changes in patient care, a reduction in the overall rate of postoperative complications was not observed. More than 3 million patients are hospitalized yearly in the United States for chest pain. The cost is over $3 billion just for those found to be free of acute disease. New rapid diagnostic tests for acute myocardial infarction (AMI) have resulted in the proliferation of accelerated diagnostic protocols (ADPs) and chest pain observation units.
                To determine whether use of an emergency department (ED)-based ADP can reduce hospital admission rate, total cost, and length of stay (LOS) for patients needing admission for evaluation of chest pain.
                Prospective randomized controlled trial comparing admission rate, total cost, and LOS for patients treated using ADP vs inpatient controls. Total costs were determined using empirically measured resource utilization and microcosting techniques.
                A large urban public teaching hospital serving a predominantly African American and Hispanic population.
                A sample of 165 patients was randomly selected from a larger consecutive sample of 429 patients with chest pain concurrently enrolled in an ADP diagnostic cohort trial. Eligible patients presented to the ED with clinical findings suggestive of AMI or acute cardiac ischemia (ACI) but at low risk using a validated predictive algorithm.
                Primary outcomes measured for each subject were LOS and total cost of treatment.
                The hospital admission rate for ADP vs control patients was 45.2% vs 100% (P<.001). The mean total cost per patient for ADP vs control patients was $1528 vs $2095 (P<.001). The mean LOS measured in hours for ADP vs control patients was 33.1 hours vs 44.8 hours (P<.01).
                In this trial, ADP saved $567 in total hospital costs per patient treated. Use of ED-based ADPs can reduce hospitalization rates, LOS, and total cost for low-risk patients with chest pain needing evaluation for possible AMI or ACI. Many physicians believe that the pulmonary artery catheter (PAC) is useful for the diagnosis and treatment of cardiopulmonary disturbances; however, observational studies suggest that its use may be harmful.
                To determine the effects on outcome of the early use of a PAC in patients with shock mainly of septic origin, acute respiratory distress syndrome (ARDS), or both.
                A multicenter randomized controlled study of 676 patients aged 18 years or older who fulfilled the standard criteria for shock, ARDS, or both conducted in 36 intensive care units in France from January 30, 1999, to June 29, 2001.
                Patients were randomly assigned to either receive a PAC (n = 335) or not (n = 341). The treatment was left to the discretion of each individual physician.
                The primary end point was mortality at 28 days. The principal secondary end points were day 14 and 90 mortality; day 14 organ system, renal support, and vasoactive agents-free days; hospital, intensive care unit, and mechanical ventilation-free days at day 28.
                The 2 groups were similar at baseline. There were no significant differences in mortality with or without the PAC at day 14: 49.9% vs 51.3% (mortality relative risk [RR], 0.97; 95% confidence interval [CI], 0.84-1.13; P =.70); day 28: 59.4% vs 61.0% (RR, 0.97; 95% CI, 0.86-1.10; P =.67); or day 90: 70.7% vs 72.0% (RR, 0.98; 95% CI, 0.89-1.08; P =.71). At day 14, the mean (SD) number of days free of organ system failures with or without the PAC (2.3 [3.6] vs 2.4 [3.5]), renal support (7.4 [6.0] vs 7.5 [5.9]), and vasoactive agents (3.8 [4.8] vs 3.9 [4.9]) did not differ. At day 28, mean (SD) days in hospital with or without the PAC (0.9 [3.6] vs 0.9 [3.3]), in the intensive care unit (3.4 [6.8] vs 3.3 [6.9]), or mechanical ventilation use (5.2 [8.5] vs 5.0 [8.5]) did not differ.
                Clinical management involving the early use of a PAC in patients with shock, ARDS, or both did not significantly affect mortality and morbidity. Continuous pulse oximetry (CPOX) has the potential to increase vigilance and decrease pulmonary complications and thus decrease intensive care unit (ICU) admissions. In a randomized nonblinded study of 1219 subjects we compared the effects of CPOX and standard monitoring on the rate of transfer to an ICU from a 33-bed postcardiothoracic surgery care floor. There was no difference in the rate of ICU readmission between the CPOX and standard monitor groups. Despite older age and comorbidity, estimated cost to time of censoring (enrollment to completion of the study) was less in the monitored patients who required ICU transfer than in the unmonitored patients who required ICU transfer (mean estimated cost difference of 28,195 dollars; P = 0.04). Use of CPOX altered the reasons that patients were transferred to an ICU but did not affect the rate of transfer. The duration, and thus estimated cost, of ICU stay was significantly less in the CPOX-monitored group. The potential for CPOX to allow for early intervention, or perhaps prevention of pulmonary complications, needs to be explored. Routine CPOX monitoring did not reduce transfer to ICU, mortality, or overall estimated cost of hospitalization, and it is unclear if there is any real benefit from the application of this technology in patients on a general care floor who are recovering from cardiothoracic surgery. Carbon dioxide (CO2) pneumoperitoneum effects are still controversial. The aim of this study was to investigate cardiopulmonary changes in patients subjected to different surgical procedures for cholecystectomy.
                In this study, 15 patients were assigned randomly to three groups according to the surgical procedure to be used: open cholecystectomy (OC), CO2 pneumoperitoneum cholecystectomy (PP), and laparoscopic gasless cholecystectomy (abdominal wall lifting [AWL]), respectively. A pulmonary artery catheter was used for hemodynamic monitoring in all patients. A subcutaneous multiplanar device (Laparo Tenser) was used for abdominal wall lifting. To avoid misinterpretation of results, conventional anesthesia was performed with all parameters, and the position of the patients held fixed throughout surgery. The following parameters were analyzed: mean arterial pressure (MAP), heart rate (HR), cardiac output (CO), cardiac index (CI), stroke volume index (SVI), central venous pressure (CVP), systemic vascular resistances index (SVRI), mean pulmonary arterial pressure (MPAP), pulmonary capillary wedge pressure (PCWP), pulmonary vascular resistances index (PVRI), peak inspiratory pressure (PIP), end-tidal CO2 pressure (ETCO)2, CO2 arterial pressure (PaCO2), and arterial pH.
                All the operations were completed successfully. The Laparo Tenser allowed good exposition of the surgical field. A slight impairment of the cardiopulmonary functions, with reduction of SVRI, MAP, and CI and elevation of pulmonary pressures and vascular resistance, followed induction of anesthesia. However, these effects tended to normalize in the OC and AWL groups over time. In contrast, CO2 insufflation produced a complex hemodynamic and pulmonary syndrome resulting in increased right- and left side filling pressures, significant cardiac index reduction, derangement of the respiratory mechanics, and respiratory acidosis. All of these effects normalized after desufflation.
                Cardiopulmonary adverse effects of general anesthesia were significant but transitory and normalized during surgery. Carbon dioxide pneumoperitoneum caused a significant impairment in cardiopulmonary functions. In high-risk patients, gasless laparoscopy may be preferred for reliability and absence of cardiopulmonary alterations. Previous investigations have suggested that preoperative invasive hemodynamic monitoring with "optimization" of cardiovascular function may favorably affect the outcome among patients undergoing peripheral vascular surgery. The purpose of this study was to evaluate the effect of preoperative optimization of hemodynamic parameters on outcome in patients undergoing aortic reconstruction (AR) or limb salvage procedures (LSP) in a randomized, prospective clinical trial.
                All 72 patients who consented to participate in this study were admitted to the intensive care unit at least 12 hours before operation for placement of a pulmonary artery catheter (PAC). Patients who were randomized to the treatment group (n = 32) were "optimized" by adjusting their hemoglobin concentration, oxygen saturation (SaO2), cardiac output, or afterload until the mixed venous O2 saturation (SvO2) was at least 65%. The control group (n = 40) underwent placement of a PAC and had oxygen transport parameters measured without any attempt to optimize SvO2.
                There were no significant differences between the treatment and control groups with respect to age, gender, type of operation, initial Acute Physiology and Chronic Health Evaluation (APACHE) II score, SvO2, pulmonary artery occlusion pressure, or cardiac index. All treatment patients achieved an SvO2 of at least 65% before operation. Comparing the treatment and control groups, postoperative cardiovascular complications occurred in 25% versus 27%, intraoperative complications in 28% versus 20%, and death in 9% versus 5%, respectively. None of these differences was statistically significant as a whole or within the subgroups undergoing AR or LSP.
                These data suggest that preoperative optimization of cardiovascular function by using achievement of SvO2 above 65% as the end point does not result in any reduction of intraoperative or perioperative cardiac complications in patients undergoing PVS. Further studies with alternative assessments and manipulation of different cardiopulmonary parameters may yield additional information.
PAC is a diagnostic and haemodynamic monitoring tool but not a therapeutic intervention. Our review concluded that use of a PAC did not alter the mortality, general ICU or hospital LOS, or cost for adult patients in intensive care. The quality of evidence was high for mortality and LOS but low for cost analysis. Efficacy studies are needed to determine if there are optimal PAC-guided management protocols, which when applied to specific patient groups in ICUs could result in benefits such as shock reversal, improved organ function and less vasopressor use. Newer, less-invasive haemodynamic monitoring tools need to be validated against PAC prior to clinical use in critically ill patients.