BACKGROUND The effect of different methods for data sampling and data processing on the results of comparative statistical analyses in method comparison studies of continuous arterial blood pressure (AP) monitoring systems remains unknown. OBJECTIVE We sought to investigate the effect of different methods for data sampling and data processing on the results of statistical analyses in method comparison studies of continuous AP monitoring systems. DESIGN Prospective observational study. SETTING University Medical Center Hamburg-Eppendorf, Hamburg, Germany, from April to October 2019. PATIENTS 49 patients scheduled for neurosurgery with AP measurement using a radial artery catheter. MAIN OUTCOME MEASURES We assessed the agreement between continuous noninvasive finger cuff-derived (CNAP Monitor 500; CNSystems Medizintechnik, Graz, Austria) and invasive AP measurements in a prospective method comparison study in patients having neurosurgery using all beat-to-beat AP measurements (Method all ), 10-s averages (Method avg ), one 30-min period of 10-s averages (Method 30 ), Method 30 with additional offset subtraction (Method 30off ), and 10 30-s periods without (Method iso ) or with (Method iso-zero ) application of the zero zone. The agreement was analysed using Bland-Altman and error grid analysis. RESULTS For mean AP, the mean of the differences (95% limits of agreement) was 9.0 (−12.9 to 30.9) mmHg for Method all , 9.2 (−12.5 to 30.9) mmHg for Method avg , 6.5 (−9.3 to 22.2) mmHg for Method 30 , 0.5 (−9.5 to 10.5) mmHg for Method 30off , 4.9 (−6.0 to 15.7) mmHg for Method iso , and 3.4 (−5.9 to 12.7) mmHg for Method iso-zero . Similar trends were found for systolic and diastolic AP. Results of error grid analysis were also influenced by using different methods for data sampling and data processing. CONCLUSION Data sampling and data processing substantially impact the results of comparative statistics in method comparison studies of continuous AP monitoring systems. Depending on the method used for data sampling and data processing, the performance of an AP test method may be considered clinically acceptable or unacceptable.
The finger-cuff system CNAP (CNSystems Medizintechnik, Graz, Austria) allows non-invasive automated measurement of pulse pressure variation (PPVCNAP). We sought to validate the PPVCNAP-algorithm and investigate the agreement between PPVCNAP and arterial catheter-derived manually calculated pulse pressure variation (PPVINV). This was a prospective method comparison study in patients having neurosurgery. PPVINV was the reference method. We applied the PPVCNAP-algorithm to arterial catheter-derived blood pressure waveforms (PPVINV-CNAP) and to CNAP finger-cuff-derived blood pressure waveforms (PPVCNAP). To validate the PPVCNAP-algorithm, we compared PPVINV-CNAP to PPVINV. To investigate the clinical performance of PPVCNAP, we compared PPVCNAP to PPVINV. We used Bland-Altman analysis (absolute agreement), Deming regression, concordance, and Cohen's kappa (predictive agreement for three pulse pressure variation categories). We analyzed 360 measurements from 36 patients. The mean of the differences between PPVINV-CNAP and PPVINV was -0.1% (95% limits of agreement (95%-LoA) -2.5 to 2.3%). Deming regression showed a slope of 0.99 (95% confidence interval (95%-CI) 0.91 to 1.06) and intercept of -0.02 (95%-CI -0.52 to 0.47). The predictive agreement between PPVINV-CNAP and PPVINV was 92% and Cohen's kappa was 0.79. The mean of the differences between PPVCNAP and PPVINV was -1.0% (95%-LoA-6.3 to 4.3%). Deming regression showed a slope of 0.85 (95%-CI 0.78 to 0.91) and intercept of 0.10 (95%-CI -0.34 to 0.55). The predictive agreement between PPVCNAP and PPVINV was 82% and Cohen's kappa was 0.48. The PPVCNAP-algorithm reliably calculates pulse pressure variation compared to manual offline pulse pressure variation calculation when applied on the same arterial blood pressure waveform. The absolute and predictive agreement between PPVCNAP and PPVINV are moderate.
Pulse pressure variation (PPV) is a dynamic cardiac preload variable used to predict fluid responsiveness. PPV can be measured non-invasively using innovative finger-cuff systems allowing for continuous arterial pressure waveform recording, e.g., the Nexfin system [BMEYE B.V., Amsterdam, The Netherlands; now Clearsight (Edwards Lifesciences, Irvine, CA, USA)] (PPVFinger). However, the agreement between PPVFinger and PPV derived from an arterial catheter (PPVART) in obese patients having laparoscopic bariatric surgery is unknown. We compared PPVFinger and PPVART at 6 time points in 60 obese patients having laparoscopic bariatric surgery in a secondary analysis of a prospective method comparison study. We used Bland-Altman analysis to assess absolute agreement between PPVFinger and PPVART. The predictive agreement for fluid responsiveness between PPVFinger and PPVART was evaluated across three PPV categories (PPV < 9%, PPV 9-13%, PPV > 13%) as concordance rate of paired measurements and Cohen's kappa. The overall mean of the differences between PPVFinger and PPVART was 0.5 ± 4.6% (95%-LoA - 8.6 to 9.6%) and the overall predictive agreement was 72.4% with a Cohen's kappa of 0.53. The mean of the differences was - 0.7 ± 3.8% (95%-LoA - 8.1 to 6.7%) without pneumoperitoneum in horizontal position and 1.1 ± 4.8% (95%-LoA - 8.4 to 10.5%) during pneumoperitoneum in reverse-Trendelenburg position. The absolute agreement and predictive agreement between PPVFinger and PPVART are moderate in obese patients having laparoscopic bariatric surgery.
Postoperative mortality is a major healthcare problem. In order to decrease postoperative mortality, avoiding postoperative complications is key. In turn, to avoid postoperative complications, modifiable risk factors independently associated with these complications need to be identified and avoided. One of the modifiable risk factors for postoperative complications may be perioperative hypotension— i.e., low blood pressure in the perioperative period. In this review, we discuss perioperative hypotension that includes intraoperative hypotension (IOH) and postoperative hypotension (POH), and its impact on postoperative patient outcomes, challenges related to its diagnosis, and potential therapeutic approaches. IOH is common in patients having non-cardiac surgery under general anesthesia and is associated with acute kidney injury, myocardial injury, and death. The relationship between IOH and serious postoperative complications is supported by many observational analyses and one randomized trial that suggests that individualized blood pressure management reduces the risk of postoperative organ dysfunction compared with usual care. More randomized controlled trials are needed before recommendations can be given on how to individualize intraoperative blood pressure targets in clinical routine. POH refers to hypotension occurring on the remaining day of surgery and during the first days after surgery. Available data suggest that POH after non-cardiac surgery is common, profound, and largely undetected by current vital sign monitoring on the general care ward. There is evidence that POH is associated with adverse postoperative outcomes, especially myocardial injury, acute kidney injury, and death. However, there is a need for more data on the pathophysiology, impact, and management of POH. Continuous ward monitoring might enable POH to be detected and treated in a timely manner. However, strategies to prevent or treat POH based on continuous ward monitoring need to be tested for their effectiveness to improve quality of care or patient- centered outcomes in large-scale interventional trials.
Abstract Intraoperative hypotension is common and associated with organ injury. Hypotension can not only occur during surgery, but also thereafter. After surgery, most patients are treated in post-anesthesia care units (PACU). The incidence of PACU hypotension is largely unknown – presumably in part because arterial pressure is usually monitored intermittently in PACU patients. We therefore aimed to evaluate the incidence, duration, and severity of PACU hypotension in low-risk patients recovering from non-cardiac surgery. In this observational study, we performed blinded continuous non-invasive arterial pressure monitoring with finger-cuffs (ClearSight system; Edwards Lifesciences, Irvine, CA, USA) in 100 patients recovering from non-cardiac surgery in the PACU. We defined PACU hypotension as a mean arterial pressure (MAP) < 65 mmHg. Patients had continuous finger-cuff monitoring for a median (25th percentile, 75th percentile) of 64 (44 to 91) minutes. Only three patients (3%) had PACU hypotension for at least one consecutive minute. These three patients had 4, 4, and 2 cumulative minutes of PACU hypotension; areas under a MAP of 65 mmHg of 17, 9, and 9 mmHg x minute; and time-weighted averages MAP less than 65 mmHg of 0.5, 0.3, and 0.2 mmHg. The median volume of crystalloid fluid patients were given during PACU treatment was 200 (100 to 400) ml. None was given colloids or a vasopressor during PACU treatment. In low-risk patients recovering from non-cardiac surgery, the incidence of PACU hypotension was very low and the few episodes of PACU hypotension were short and of modest severity.
Abstract It remains unclear whether reduced myocardial contractility, venous dilation with decreased venous return, or arterial dilation with reduced systemic vascular resistance contribute most to hypotension after induction of general anesthesia. We sought to assess the relative contribution of various hemodynamic mechanisms to hypotension after induction of general anesthesia with sufentanil, propofol, and rocuronium. In this prospective observational study, we continuously recorded hemodynamic variables during anesthetic induction using a finger-cuff method in 92 non-cardiac surgery patients. After sufentanil administration, there was no clinically important change in arterial pressure, but heart rate increased from baseline by 11 (99.89% confidence interval: 7 to 16) bpm (P < 0.001). After administration of propofol, mean arterial pressure decreased by 23 (17 to 28) mmHg and systemic vascular resistance index decreased by 565 (419 to 712) dyn*s*cm −5 *m 2 (P values < 0.001). Mean arterial pressure was < 65 mmHg in 27 patients (29%). After propofol administration, heart rate returned to baseline, and stroke volume index and cardiac index remained stable. After tracheal intubation, there were no clinically important differences compared to baseline in heart rate, stroke volume index, and cardiac index, but arterial pressure and systemic vascular resistance index remained markedly decreased. Anesthetic induction with sufentanil, propofol, and rocuronium reduced arterial pressure and systemic vascular resistance index. Heart rate, stroke volume index, and cardiac index remained stable. Post-induction hypotension therefore appears to result from arterial dilation with reduced systemic vascular resistance rather than venous dilation or reduced myocardial contractility.
Pulmonary artery thermodilution is the clinical reference method for cardiac output monitoring. Because both continuous and intermittent pulmonary artery thermodilution are used in clinical practice it is important to know whether cardiac output measurements by the two methods are clinically interchangeable.We performed a systematic review and meta-analysis of clinical studies comparing cardiac output measurements assessed using continuous and intermittent pulmonary artery thermodilution in adult surgical and critically ill patients. 54 studies with 1522 patients were included in the analysis.The heterogeneity across the studies was high. The overall random effects model-derived pooled estimate of the mean of the differences was 0.08 (95%-confidence interval 0.01 to 0.16) L/min with pooled 95%-limits of agreement of - 1.68 to 1.85 L/min and a pooled percentage error of 29.7 (95%-confidence interval 20.5 to 38.9)%.The heterogeneity across clinical studies comparing continuous and intermittent pulmonary artery thermodilution in adult surgical and critically ill patients is high. The overall trueness/accuracy of continuous pulmonary artery thermodilution in comparison with intermittent pulmonary artery thermodilution is good (indicated by a pooled mean of the differences < 0.1 L/min). Pooled 95%-limits of agreement of - 1.68 to 1.85 L/min and a pooled percentage error of 29.7% suggest that continuous pulmonary artery thermodilution barely passes interchangeability criteria with intermittent pulmonary artery thermodilution. PROSPERO registration number CRD42020159730.
Intraoperative hypotension (IOH) i.e., low arterial blood pressure (AP) during surgery is common in patients having non-cardiac surgery under general anaesthesia. It has a multifactorial aetiology, and is associated with major postoperative complications including acute kidney injury, myocardial injury and death. Therefore, IOH may be a modifiable risk factor for postoperative complications. However, there is no uniform definition for IOH. IOH not only occurs during surgery but also after the induction of general anaesthesia before surgical incision. However, the optimal therapeutic approach to IOH remains elusive. There is evidence from one small randomised controlled trial that individualising AP targets may reduce the risk of postoperative organ dysfunction compared with standard care. More research is needed to define individual AP harm thresholds, to develop therapeutic strategies to treat and avoid IOH, and to integrate new technologies for continuous AP monitoring.
