scholarly journals Intraoperative Hemodynamic Optimization Using The Hypotension Prediction Index And Its Impact Of Tissular Perfusion. Protocol For The Predict H Trial

2021 ◽  
Author(s):  
Juan Victor Lorente Olazábal ◽  
Ignacio Jiménez ◽  
Javier Ripollés-Melchor ◽  
Alejandra Isabel Becerra ◽  
Wilbert Wesselink ◽  
...  
Keyword(s):  
Arterial Pressure ◽  
Intervention Group ◽  
Weighted Average ◽  
Arterial Hypotension ◽  
Tissue Oxygen Saturation ◽  
Control Group ◽  
Hemodynamic Parameters ◽  
Hemodynamic Management ◽  
Intraoperative Hypotension ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index, developed from machine learning, predicts the occurrence of arterial hypotension from the analysis of the arterial pressure waveform. The use of this index can reduce the duration and severity of intraoperative hypotension in adults undergoing noncardiac surgery.Methods: We will conduct a multicenter, randomized, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Hemodynamic management in the control group will be based on standard hemodynamic parameters. Hemodynamic management of patients in the intervention group will be based on functional hemodynamic parameters provided by the HemoSphere platform (Edwards Lifesciences Corp.), including dynamic arterial elastance, dP/dtmax and the Hypotension Prediction Index. Tissue oxygen saturation will be non-invasively and continuously recorded by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be intraoperative time-weighted average of a mean arterial pressure < 65mmHg.Discussion: The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy is associated with better tissue oxygenation and organ perfusion. Trial registration: ClinicalTrials.gov, NCT04301102. Registered on March 10, 2020.

scholarly journals The Use of the Hypotension Prediction Index Integrated in an Algorithm of Goal Directed Hemodynamic Treatment during Moderate and High-Risk Surgery

2021 ◽  
Vol 10 (24) ◽  
pp. 5884
Author(s):  
Marina Tsoumpa ◽  
Aikaterini Kyttari ◽  
Stamo Matiatou ◽  
Maria Tzoufi ◽  
Panayota Griva ◽  
...  
Keyword(s):  
High Risk ◽  
Arterial Pressure ◽  
Intervention Group ◽  
Treatment Protocol ◽  
Group Versus ◽  
Weighted Average ◽  
Standard Of Care ◽  
Noncardiac Surgery ◽  
Control Group ◽  
Intraoperative Hypotension

(1) Background: The Hypotension Prediction Index (HPI) is an algorithm that predicts hypotension, defined as mean arterial pressure (MAP) less than 65 mmHg for at least 1 min, based on arterial waveform features. We tested the hypothesis that the use of this index reduces the duration and severity of hypotension during noncardiac surgery. (2) Methods: We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized 1:1 to standard of care or hemodynamic management with HPI guidance with a goal directed hemodynamic treatment protocol. The trigger to initiate treatment (with fluids, vasopressors, or inotropes) was a value of HPI of 85 (range, 0–100) or higher in the intervention group. Primary outcome was the amount of hypotension, defined as time-weighted average (TWA) MAP less than 65 mmHg. Secondary outcomes were time spent in hypertension defined as MAP more than 100 mmHg for at least 1 min; medication and fluids administered and postoperative complications. (3) Results: We obtained data from 99 patients. The median (IQR) TWA of hypotension was 0.16 mmHg (IQR, 0.01–0.32 mmHg) in the intervention group versus 0.50 mmHg (IQR, 0.11–0.97 mmHg) in the control group, for a median difference of −0.28 (95% CI, −0.48 to −0.09 mmHg; p = 0.0003). We also observed an increase in hypertension in the intervention group as well as a higher weight-adjusted administration of phenylephrine in the intervention group. (4) Conclusions: In this single-center prospective study of patients undergoing elective noncardiac surgery, the use of this prediction model resulted in less intraoperative hypotension compared with standard care. An increase in the time spent in hypertension in the treatment group was also observed, probably as a result of overtreatment. This should provide an insight for refining the use of this prediction index in future studies to avoid excessive correction of blood pressure.

scholarly journals Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial

2022 ◽  
Vol 11 (2) ◽  
pp. 392
Author(s):  
Paolo Murabito ◽  
Marinella Astuto ◽  
Filippo Sanfilippo ◽  
Luigi La Via ◽  
Francesco Vasile ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Intervention Group ◽  
Weighted Average ◽  
Organ Injury ◽  
Secondary Outcome ◽  
Control Group ◽  
Proactive Management ◽  
Intraoperative Hypotension ◽  
Time Weighted Average ◽  
And Oxidative Stress

Background: Intraoperative hypotension is associated with increased postoperative morbidity and mortality. Methods: We randomly assigned patients undergoing major general surgery to early warning system (EWS) and hemodynamic algorithm (intervention group, n = 20) or standard care (n = 20). The primary outcome was the difference in hypotension (defined as mean arterial pressure < 65 mmHg) and as secondary outcome surrogate markers of organ injury and oxidative stress. Results: The median number of hypotensive episodes was lower in the intervention group (−5.0 (95% CI: −9.0, −0.5); p < 0.001), with lower time spent in hypotension (−12.8 min (95% CI: −38.0, −2.3 min); p = 0.048), correspondent to −4.8% of total surgery time (95% CI: −12.7, 0.01%; p = 0.048).The median time-weighted average of hypotension was 0.12 mmHg (0.35) in the intervention group and 0.37 mmHg (1.11) in the control group, with a median difference of −0.25 mmHg (95% CI: −0.85, −0.01; p = 0.025). Neutrophil Gelatinase-Associated Lipocalin (NGAL) correlated with time-weighted average of hypotension (R = 0.32; p = 0.038) and S100B with number of hypotensive episodes, absolute time of hypotension, relative time of hypotension and time-weighted average of hypotension (p < 0.001 for all). The intervention group showed lower Neuronal Specific Enolase (NSE) and higher reduced glutathione when compared to the control group. Conclusions: The use of an EWS coupled with a hemodynamic algorithm resulted in reduced intraoperative hypotension, reduced NSE and oxidative stress.

scholarly journals Performance of Hypotension Prediction Index for Prevention of Hypotension and Results on Biomarkers of Organ Injury and Oxidative Stress During Elective Non-Cardiac Surgery: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Paolo Murabito ◽  
Marinella Astuto ◽  
Filippo Sanfilippo ◽  
Luigi La Via ◽  
Francesco Basile ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Reduced Glutathione ◽  
Intervention Group ◽  
Weighted Average ◽  
Organ Injury ◽  
Secondary Outcome ◽  
Control Group ◽  
Intraoperative Hypotension ◽  
Time Weighted Average ◽  
And Oxidative Stress

Abstract Background: Intraoperative hypotension is associated with increased postoperative morbidity and mortality. We tested whether the clinical application of an early warning system (EWS) in combination with an algorithm for hemodynamic management reduces the occurrence of intraoperative hypotension as well as decrease the degree of organ injury and oxidative stress. Methods: We randomly assigned patients undergoing major general surgery EWS and hemodynamic algorithm (intervention group, n=20) or standard care (n=20). The primary outcome was the difference in hypotension (defined as mean arterial pressure<65mmHg) evaluated as episodes, time and time-weighted average of hypotension. As secondary outcome we assessed surrogate markers of organ injury (neuron specific enolase -NSE), S100B protein, high-sensitive troponin, neutrophil gelatinase-associated lipocalin -NGAL) and oxidative stress (reduced glutathione). Results: The median number of hypotensive episodes was lower in the intervention group [-5.0 (95%CI:-9.0,-0.5);P<0.005], with lower time spent in hypotension [-12.8 minutes (95%CI:-38.0,-2.3 min);P<0.001], correspondent to -4.8% of total surgery time (95%CI: -12.7,0.01%; P<0.05). The median time-weighted average of hypotension was 0.12 mmHg (0.35) in the intervention group and 0.37 mmHg (1.11) in the control group, with a median difference of -0.25 mmHg (95%CI:-0.85, -0.01;P<0.05). NGAL was correlated with time-weighted average of hypotension (R=0.32;P<0.05) and S100B with all primary outcomes investigated (all P<0.001). The intervention group had lower NSE and higher reduced glutathione when compared to the control group. Conclusions: The use of an EWS coupled with an hemodynamic algorithm resulted in reduced intraoperative hypotension. This finding was coupled with a reduction of biomarkers of brain injury and oxidative stress.Trial Registration number and date: “Correlation Between Circulating Biomarkers of Organ Damage and Intraoperative Hypotension Management”, NCT03527758, registered on May 17, 2018.https://www.clinicaltrials.gov/ct2/show/NCT03527758?term=NCT03527758&draw=2&rank=1

scholarly journals Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Qiong-Fang Wu ◽  
Hao Kong ◽  
Zhen-Zhen Xu ◽  
Huai-Jin Li ◽  
Dong-Liang Mu ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Partial Nephrectomy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kidney Injury ◽  
Control Group ◽  
Hemodynamic Management ◽  
Randomized Controlled ◽  
Renal Hilum ◽  
Pilot Randomized Controlled Trial

Abstract Background The incidence of acute kidney injury (AKI) remains high after partial nephrectomy. Ischemia-reperfusion injury produced by renal hilum clamping during surgery might have contributed to the development of AKI. In this study we tested the hypothesis that goal-directed fluid and blood pressure management may reduce AKI in patients following partial nephrectomy. Methods This was a pilot randomized controlled trial. Adult patients who were scheduled to undergo partial nephrectomy were randomized into two groups. In the intervention group, goal-directed hemodynamic management was performed from renal hilum clamping until end of surgery; the target was to maintain stroke volume variation < 6%, cardiac index 3.0–4.0 L/min/m2 and mean arterial pressure > 95 mmHg with crystalloid fluids and infusion of dobutamine and/or norepinephrine. In the control group, hemodynamic management was performed according to routine practice. The primary outcome was the incidence of AKI within the first 3 postoperative days. Results From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n = 72; control group, n = 72). AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28–1.28; P = 0.180). No significant differences were found regarding AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality between the two groups. Conclusion For patients undergoing partial nephrectomy, goal-directed circulatory management during surgery reduced postoperative AKI by about 40%, although not significantly so. The trial was underpowered. Large sample size randomized trials are needed to confirm our results. Trial registration Clinicaltrials.gov identifier: NCT02803372. Date of registration: June 6, 2016.

P1674High intensity interval exercise program in heart failure patients seems to benefit cardiac power along with aorto-ventricular mechanical pump capacity and cardiorespiratory indices

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Chrysohoou ◽  
A Angelis ◽  
G Titsinakis ◽  
D Tsiachris ◽  
P Aggelopoulos ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Pulse Wave Velocity ◽  
Pulse Wave ◽  
Intervention Group ◽  
Control Group ◽  
Interval Exercise ◽  
Cardiac Power

Abstract Background Cardiac power has been suggested as the most power predictor of mortality in heart failure (HF) patients. In those patients aorta elastic properties and compensation is lost, systolic (and pulse) pressure are therefore reduced and associated with a decrease in ejection duration and pump efficiency. Cardiac rehabilitation programs have showed enhancement in cardiac performance and quality of life in HF patients. Aim Aim of this work was to evaluate the effect of high-intensity interval exercise (i.e., 30 sec at 100% of max workload, followed by 30 sec at rest, on a day-by-day 30 minutes working-out schedule for 12 weeks), on cardiac power, diastolic function indices, right ventricle performance and cardiorespiratory parameters among chronic HF patients. Methods 72 consecutive HF patients (NYHA class II-IV, ejection fraction <50%) who completed the study (exercise training group, n=33, 63±9 years, 88% men, and control group, n=39, 56±11 years, 82% men), underwent cardiopulmonary stress test, non-invasive high-fidelity tonometry of the radial artery, pulse wave velocity measurement using a SphygmoCor device, and echocardiography before and after completion of the training program. Cardiac power output (CPO) (W) was calculated as mean arterial pressure × CO/451, where mean arterial pressure = [(systolic blood pressure − diastolic blood pressure)/3] + diastolic blood pressure. Results Both groups reported similar medical characteristics and physical activity status. General mixed effects models revealed that the intervention group increased 6MWT (by 13%, p<0.05); increased cycle ergometry WRpeak (by 25%, p<0.01), showed higher O2max by 31% (p<0.001) and lower VE/VCO2 (p=0.05), whereas patients in the control group showed nosignificant changes in the aforementioned indices. Also, in the intervention group Emv/Vp was decreased by 14% (p=0.06); E to A ratio by 24% (p=0.004) and E to Emv ratio by 8% (p=0.05); while Stv increased by 25% (p=0.01). Most importantly, the intervention group reduced pulse wave velocity by 9% (p=0.05) and increased augmentation index by 26%; and VTI by 4% (p=0.05); Those parameters were not significantly changed on control group (all p>0.05). Conclusion Hight intensity exercise rehabilitation program revealed beneficial effect on left ventricular diastolic indices and right ventricle performance. As, in those patients compensation of the aorta is also lost and the LV cannot generate the extra force necessary to completely overcome the late systolic augmented pressure, the increase in the augmented pressure (AIa) observed in the intervention group reflects the benefit in aorto-ventricular coupling and cardiac power that boosts systolic pressure and restores a positive influence in pressure, like in early stages of HF. Acknowledgement/Funding None

An improvement in self-care behaviour in heart failure patients lead to better management of hypertension

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.S Sahlin ◽  
S Gerward
Keyword(s):  
Heart Failure ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Chi Square ◽  
Home Based ◽  
Number Of Patients

Abstract Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg &lt; MAP &lt;100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP &gt;100 mmHg, with 22% in the CG versus 16% in the IG having MAP &gt;100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None

scholarly journals The evolution of mean arterial pressure in critically ill patients on vasopressors before and during a trial comparing a specific mean arterial pressure target to usual care

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Marie-Hélène Masse ◽  
Neill K. J. Adhikari ◽  
Xavier Théroux ◽  
Marie-Claude Battista ◽  
Frédérick D’Aragon ◽  
...  
Keyword(s):  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Usual Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Control Group ◽  
Chronic Hypertension ◽  
The Mean ◽  
Change In Mean

Abstract Background In randomized clinical controlled trials, the choice of usual care as the comparator may be associated with better clinician uptake of the study protocol and lead to more generalizable results. However, if care processes evolve to resemble the intervention during the course of a trial, differences between the intervention group and usual care control group may narrow. We evaluated the effect on mean arterial pressure of an unblinded trial comparing a lower mean arterial pressure target to reduce vasopressor exposure, vs. a clinician-selected mean arterial pressure target, in critically ill patients at least 65 years old. Methods For this multicenter observational study using data collected both prospectively and retrospectively, patients were recruited from five of the seven trial sites. We compared the mean arterial pressure of patients receiving vasopressors, who met or would have met trial eligibility criteria, from two periods: [1] at least 1 month before the trial started, and [2] during the trial period and randomized to usual care, or not enrolled in the trial. Results We included 200 patients treated before and 229 after trial initiation. There were no differences in age (mean 74.5 vs. 75.2 years; p = 0.28), baseline Acute Physiology and Chronic Health Evaluation II score (median 26 vs. 26; p = 0.47) or history of chronic hypertension (n = 126 [63.0%] vs. n = 153 [66.8%]; p = 0.41). Mean of the mean arterial pressure was similar between the two periods (72.5 vs. 72.4 mmHg; p = 0.76). Conclusions The initiation of a trial of a prescribed lower mean arterial pressure target, compared to a usual clinician-selected target, was not associated with a change in mean arterial pressure, reflecting stability in the net effect of usual clinician practices over time. Comparing prior and concurrent control groups may alleviate concerns regarding drift in usual practices over the course of a trial or permit quantification of any change.

scholarly journals Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO)

2017 ◽  
Vol 24 (10) ◽  
pp. 1375-1382 ◽  
Author(s):  
Vanessa Vermöhlen ◽  
Petra Schiller ◽  
Sabine Schickendantz ◽  
Marion Drache ◽  
Sabine Hussack ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Health Score ◽  
Multicenter Randomized Controlled Trial

Background: Evidence-based complementary treatment options for multiple sclerosis (MS) are limited. Objective: To investigate the effect of hippotherapy plus standard care versus standard care alone in MS patients. Methods: A total of 70 adults with MS were recruited in five German centers and randomly allocated to the intervention group (12 weeks of hippotherapy) or the control group. Primary outcome was the change in the Berg Balance Scale (BBS) after 12 weeks, and further outcome measures included fatigue, pain, quality of life, and spasticity. Results: Covariance analysis of the primary endpoint resulted in a mean difference in BBS change of 2.33 (95% confidence interval (CI): 0.03–4.63, p = 0.047) between intervention ( n = 32) and control ( n = 38) groups. Benefit on BBS was largest for the subgroup with an Expanded Disability Status Scale (EDSS) ⩾ 5 (5.1, p = 0.001). Fatigue (−6.8, p = 0.02) and spasticity (−0.9, p = 0.03) improved in the intervention group. The mean difference in change between groups was 12.0 ( p < 0.001) in physical health score and 14.4 ( p < 0.001) in mental health score of Multiple Sclerosis Quality of Life-54 (MSQoL-54). Conclusion: Hippotherapy plus standard care, while below the threshold of a minimal clinically important difference, significantly improved balance and also fatigue, spasticity, and quality of life in MS patients.

scholarly journals Impact of Goal-directed Hemodynamic Management on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Qiong-Fang Wu ◽  
Hao Kong ◽  
Zhen-Zhen Xu ◽  
Huai-Jin Li ◽  
Dong-Liang Mu ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Partial Nephrectomy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kidney Injury ◽  
Control Group ◽  
Hemodynamic Management ◽  
Randomized Controlled ◽  
Renal Hilum ◽  
Pilot Randomized Controlled Trial

Abstract Background: The incidence of acute kidney injury (AKI) remains high after partial nephrectomy. Ischemia-reperfusion injury produced by renal hilum clamping during surgery might have contributed to the development of AKI. In this study we tested the hypothesis that goal-directed fluid and blood pressure management could reduce AKI in patients following partial nephrectomy. Methods: This was a pilot randomized controlled trial. Adult patients who were scheduled to undergo partial nephrectomy were randomized into two groups. In the intervention group, goal-directed hemodynamic management was performed from renal hilum clamping until end of surgery; the target was to maintain stroke volume variation < 6%, cardiac index 3.0 - 4.0 L/min/m2 and mean arterial pressure > 95mmHg with crystalloid fluids and infusion of dobutamine and/or norepinephrine. In the control group, hemodynamic management was performed according to routine practice. The primary outcome was the incidence of AKI within the first 3 postoperative days. Results: From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n = 72, control group, n = 72). AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28-1.28; P = 0.180). No significant differences were found regarding AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality between the two groups.Conclusion: For patients undergoing partial nephrectomy, goal-directed circulatory management during surgery reduced postoperative AKI by about 40%, although not significantly so. The trial was underpowered. Large sample size randomized trials are needed to confirm our results.Trial registration: Clinicaltrials.gov identifier: NCT02803372. Date of registration: June 6, 2016.

scholarly journals Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery

2020 ◽  
Vol 133 (6) ◽  
pp. 1214-1222 ◽  
Author(s):  
Kamal Maheshwari ◽  
Tetsuya Shimada ◽  
Dongsheng Yang ◽  
Sandeep Khanna ◽  
Jacek B. Cywinski ◽  
...  
Keyword(s):  
Mean Arterial Pressure ◽  
High Risk ◽  
Arterial Pressure ◽  
Pilot Trial ◽  
Treatment Algorithm ◽  
Weighted Average ◽  
Noncardiac Surgery ◽  
Intraoperative Hypotension ◽  
Time Weighted Average ◽  
Alert Threshold

Background The Hypotension Prediction Index is a commercially available algorithm, based on arterial waveform features, that predicts hypotension defined as mean arterial pressure less than 65 mmHg for at least 1 min. We therefore tested the primary hypothesis that index guidance reduces the duration and severity of hypotension during noncardiac surgery. Methods We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized to hemodynamic management with or without index guidance. Clinicians caring for patients assigned to guidance were alerted when the index exceeded 85 (range, 0 to 100) and a treatment algorithm based on advanced hemodynamic parameters suggested vasopressor administration, fluid administration, inotrope administration, or observation. Primary outcome was the amount of hypotension, defined as time-weighted average mean arterial pressure less than 65 mmHg. Secondary outcomes were time-weighted mean pressures less than 60 and 55 mmHg. Results Among 214 enrolled patients, guidance was provided for 105 (49%) patients randomly assigned to the index guidance group. The median (first quartile, third quartile) time-weighted average mean arterial pressure less than 65 mmHg was 0.14 (0.03, 0.37) in guided patients versus 0.14 (0.03, 0.39) mmHg in unguided patients: median difference (95% CI) of 0 (–0.03 to 0.04), P = 0.757. Index guidance therefore did not reduce amount of hypotension less than 65 mmHg, nor did it reduce hypotension less than 60 or 55 mmHg. Post hoc, guidance was associated with less hypotension when analysis was restricted to episodes during which clinicians intervened. Conclusions In this pilot trial, index guidance did not reduce the amount of intraoperative hypotension. Half of the alerts were not followed by treatment, presumably due to short warning time, complex treatment algorithm, or clinicians ignoring the alert. In the future we plan to use a lower index alert threshold and a simpler treatment algorithm that emphasizes prompt treatment. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

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