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    2020 Effect of a Machine Learning–Derived Early Warning System for Intraoperative Hypotension

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    2020 Effect of A Machine Learning-Derived Early Warning System For Intraoperative Hypotension

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    Resexch JAMA | Preliminary Communication | CARING FOR THE CRITICALLY ILL PATIENT Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery The HYPE Randomized Clinical Trial Marj Wipberge, MD; art F. Gees, MO, PhO, MSc, MBA: List Hol MO; Nal Leramers, MO, ai Mule, Se: Park Berge MD: my Schenk, MSc: Lotte. Terwinct, MD: ‘Mars W Hellmann MD, PhO, Alexander P Via 1D, PRD, MBA, Denise, eel, MO, HO Visual Abstract IMPORTANCE Intreoperative hypotension is associated with increased morbidity and tort ‘mortality. A machine learning- derived early warning system to predict hypotension shortly before it occurs has been developed and validated. Supplemental content (OBJECTIVE To test whether the clinical application ofthe early warring system in combination with aerodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension DESIGN, SETTING, AND PARTICIPANTS Preliminary unblinded randomized dina trial Performedin tertiary center in Amsterdam, the Netherlands, among adult patients Schedule for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and “March 2018. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for atleast minute INTERVENTIONS Patients were randomly assigned to receive ether the early warning system (= 34) standard care (n= 34), with goal MAP of atleast 65 mm Hgin both groups. [MAIN OUTCOMES AND MEASURES The primary outcome was time-weighted average of hypotension during surgery with a unit of measure of milimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg Gin milimeters cof mercury) time spent below a MAP of 65 mm Hg Gin minutes divided by total uration of operation (in minutes) [RESULTS Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {\OR), 5770] years; 26 [43%] women). The median length of surgery was 256 minutes (QR, 213-430 minutes). The median time-weighted average of hypotension was 010 mm Hg (OR, 0.01-0.43 mm Hg) nthe intervention group vs 0.44 mm Hg. ((QR, 0.23-0.72 mm Hg) in the control group for a median diference of 038 mm Hg (95% Cl, (014-0.43 mmHg; P= 001). The median time of hypotension per patent was 8.0 minutes (QR, 133-2600 minutes inthe intervention group v5327 minutes IQR, 115-597 minutes) thor fiations Depart of doesthescogy. mse UNC Inthe contol group, fora median difference of 167 minutes (35% Cl, 77-310 minutes: renin ane ance tha .00). Inthe intervention group, O serious adverse events resuiting indeath occurred Netherlands (nberbe Gers Ho 152 (73) inthe contrl grou mers, Ade erg Scheni 2 See Twine, Hoar. ee) ‘CONCLUSIONS AND RELEVANCE inthis single-center preliminary study of patients undergoing _Dspatmentofwarsive Cae ‘rsa UMC Location ANC, elective noncardiac surgery, the use of amachine learning-derved early warning system sreariantDi tension compared with standard care resulted ines intraoperative hypotension. Further research ‘rnbure Vicon, Dopatnentot with larger study populations in diverse settings is needed to understand the effect on Techn Mele Uva of additional patient outcomes an to fully assess safety and generalizability. Treats Goede atone TRIAL REGISTRATION Cincaas go Identifier: NCTO3376347 Comesponding tho: Asner. Vane. MO, Pm. MBA. Department of rts Care Amstrdam UMC, Location ANC beret, "OS AZAnsterdam the Netherton apvaxasrstertarure ‘Section ator: Deak Ang. MD, a door 2020.0592 bv asso Er, ane Puastednine February 72020 (argisde@upme et. (© 2020 American Medical Association. All ights reserved. Downloaded From: httpsi/jamanetwork.com/ on 02/17/2020 Reser, Prlminary Communication ‘worldwide in 2015.' One of the risks patients com- ‘monly face is intraoperative hypotension. A previous study involving 255 patients reported that 87% experienced 1 ‘or mote hypotensive episodes intraoperatively (with hypo- tension defined asa mean arterial pressure MAP] <65 mm ig)” Reported causes are anesthetic drugs, existing comorbidi- ties, and surgical manipulation. Clinical cohort studies have shown intraoperative hypo: tension in noncardiac surgery to be associated with postop: erative complications suchas renal insufficiency, myocardial ‘injury, and increased mortalty.*"° Current management of intraoperative hypotensive epl- sodes is predominantly reactive. Recently, Fiatib etal devel ‘oped an algorithm with the use of machine learning to pre- dict hypotension minutes before blood pressure actually decteases, the Hypotension Prediction Index. This algorithm (hereafter referred to asthe early warning system) was devel- ‘oped using the arterial waveform data of 1344 patients, and it has been internally and externally validated, showing a sens tivity of 889% and a specificity of 87%." This early warning, system is flxed, meaning that it does not include dynamic Jearning changes evolving during patient care. Using an early warning system to predict hypotension does not necessarily, lead to less hypotension. Associated factors to consider are feasibility of working with this tool ané the possibility of per- forming a timely and correct intervention, Hemodynamic variables, in combination with a hemodynamic diagnostic suldance and treatment protocol, allow for determination of the underlying cause ofthe impending hypotension. A preliminary single-center randomized clinical trial (RCT) was performed. it was hypothesized that use of the carly wamning system would reduce the amount of hypoten- sion (MAP <55 mm Hg) as measured by time-weighted aver- age during major noncardiac surgery. A ‘estimated 266 million operations were performed Methods Participants ‘The Hypotension Prediction (HYPE) tral was a preliminary investigator-initiated single-center RCT. The study took place at the Amsterdam University Medical Centers, Loca- tion AMC, a tertiary academic center in the Netherlands. ‘The study was approved by the institutional review board of the AMC (NL62115,018.17). Written informed consent was, ‘obtained from all patients the day prior to surgery by a des- ‘ignated researcher. The first participant was enrolled in May 2018, and the last follow-up was in March 2019. The tral protocol has been published previously® and is available in Supplement L ‘Adult patients (218 years old) scheduled to undergo an elective noncardiac surgical procedure under general anes- thesia with need for continuous invasive blood pressure _monitoring per arterial line were included. A target MAP of at least 65 mm Hg during surgery was obligatory to ensure both study groups to be similar in this aspect. Patients for ‘whom the attending anesthesiologists requested a target JAMA Putstedcrine Feuny 172020 ecto Machine Learig-Deived Ear Warring ys vs Stand Care on Hypotension Daring Nenearac Surgery Key Points ‘Question Cana machine earning derives predictive carly vaming ste for pending intraoperative hypotensonin ‘combination witha hemodynamic dagposticuidance and {testmentpotecl reduce the time-weighted average of Iypoterionduingnoncardiacsugey! Findings tn ths singecenter preliminary randomize nical ‘Wal thatncuded 68 patents undergoing elective noncardiac surgery. the time weighted average ofhypoterion for those randomized tothe eal wonngsystem vs those receving Standard eare was O10 mm Hg 5.44 mm Hg a difference that as satis ifort ‘Meaning Wile the ue of machin ang derive ery warming system compared with standard care rested Iles inragperatve hypotension, fuer research wth ger study populations in diverse stingsis needed to understand the eect en patient oteomes and ta fuly assess safety andgeneralzabiy [MAP higher or lower than 65 mm Hig were excluded prior to surgery. Patients undergoing emergency surgery were not cligible. Patients with cardiac failure, severe cardiac shunts, severe aortic stenosis, or severe cardiac arrhythmias were ‘excluded in accordance with the summary of product char- acteristics of the early warning system. Patients with hypo- tension (MAP <65 mm Hg) before surgery and patients requiring dialysis were also excluded, Patients planned to undergo liver surgery or vascular surgery were excluded because of the use of vascular clamping. During the trial, anesthesiologists were not allowed to use perioperative goal-directed fluid therapy because the study hemody- namic diagnostic guidance and treatment protocol has blood pressure as a starting point, while a goal-directed fluid therapy protocol typically starts with flow evaluation as the main concept. Randomization Patients were randomized to either the intraoperative early ‘warning system (intervention group) or standard care (con- ‘rol group) (Figure. Acomputer-generated permutated block randomization (concealed and varying permutated block izes ‘of 6, or 8 patients) was used with a 11 allocation ratio. The researcher performing statistical analyses was blinded to pa- tent group allocation Intervention Inall study participants an arterial catheter was placed in the radial artery and connected to the Flotrac 10. sensor with the early warning system software (Edwards Lifesciences) ‘The arterial pressure waveform was measured continuously ‘with a sample frequency of 100 Hz. The HemoSphere moni tor (Edwards Lifesciences) displayed hemodynamic para- ‘meters calculated from the waveform every 20 seconds. The value calculated by the early warning system was updated ‘every 20 seconds as well" ‘The Flotrac IQ pressure transducer was connected to the HemoSphere monitor (hereafter referred toas the study spmacom (© 2020 American Medical Association. lights reserved. Downloaded From: httpsi/jamanetwork.com/ on 02/17/2020 Efecto Machine Learn Derived Et Waring Syste vs Standard Caron Hypotension Dung Noncarac Surgery Preliminary Communication Research ‘monitor), and the resulting electrical signal was transmitted to the Philips monitor (hereafter referred to as the standard ‘monitor). The standard monitor displayed the MAP, systole, diastole, and pulse pressure varlation per standard care inthe study hospital. The quality ofthe arterial waveform signal was visually checked by the treating anesthesiologist for over- dampingand underdamping after placement ofthe arteralline ‘and during surgery. Attending anestheslologists and anesthesia nurses were informed about the study protocol and the use of the early ‘warning system the day before surgery. ntvaoperatively, an observer was present to record surgery- and anesthesia- related details. ‘Use ofthe study monitor was additional to standard care ‘monitoring. The early warning system detects deteriorations in cardiovascular compensatory mechanisms that could lead tohypotenston. The early warning system consists of 3 vai ablesthatare extracted from the arterial pressure waveform. ‘When the value ofthe early warning system alarm (hereafter referred toa the alarm) exceeds 85, the likelihood of occur- rence ofa hypotensive event within thenextISminutesisabout 85% The time to hypotension is not fixed; the progression into hypotension depends on the underlying physiological ‘mechanisms causing the hypotension and on individual pa- tient characteristics." The performance of the early warning, system regarding prediction of hypotension was analyzed on. patient data collected in the short observational study accord- ing to methods previously described by Hatib et al and pre sented in eFigure Lin Supplement 2. In this study, when the value of prediction of hypoten- sion exceeded 85% (eFigure 2 in Supplement 2), which en- talled botha sound anda ickering ight, theanesthestologist was reminded to act, preferably within 2 minutes. The study ‘monitor with the early warning system software has second ary screen (¢Figure 2) with variables (hear rate, cardiac out put, change in pressure over change in time, stroke volume, stroke volume variation, dynamic arterial elastance, and sys temic vascular resistance) that provide information about the underlying cause ofthe predicted hypotension.“ The hemo- «dynamic diagnostic guidance and treatment protocol (Figure? and eFigure 3 n Supplement 2) was designed by the authors tohelp treating anesthesiologists interpret the changes ofthe variables visible on the secondary screen." For example, the combination ofan increase arrow up)in stroke volume varia tion and a decrease (arrow down) in systemic vascular res tanceresultsin the diagnosis of vasoplegia (Figure 2 and eFig- lure 3). The hemodynamic diagnostic guidance and treatment protocol was adapted from Pinsky and Payen." Control Inthe control group, thestudy monitor was connected, but the screen was fully covered and the alarms were silenced; anes- thesiologists solely used the variables visible on the standard ‘monitor to guide hemodynamic treatment. Prior to launching the RCT, we conducted a short obser vational study to ensure thatthe care the contol group te- ceived was representative of standard care in the study hos- pital (eTables 1 and 2in Supplement 2. The only difference spracom Figure Participant Flow in the Hypotersion Prediction (HYPE) al 157 Asses ey 2 it eetisen 9 Dunedin 1 Peete theron 65 es ST faced eterna 1 tacoweanirece se ese goslaer don ‘rere olathe Srna Sienna 31 eden primary ara 3 eaced at ce ‘event 5 tacuea (a mt eae Stare) ‘between the control group and the observational study group ‘was that anestheslologists were unaware of theaimofhestudy (Coassess hypotension) in the observational study group. Al data were entered using an electronic clinical report form build in Castor EDC, a Good Clinical Practice-compliant data management system.!> Outcomes ‘The primary outcome measure was the time-weighted aver- age of hypotension during surgery. The outcome assessor was blinded to participants’ group randomization. The time- ‘weighted average combines the duration and severity (the ‘minimal MAP reached) of hypotension, corrected for the total time of surgery.!*Hypotension was defined asa MAPlessthan, (65 mm Hg for at least 1 minute. A hypotensive event ended ‘when the value normalized (MAP 265 mm Hg) forat least min- ute, The time-weighted averages measured by calculating the area under the threshold (AUT) divided by the total duration of surgery (eFigure in Supplement 2)"*": time-weighted av- erage = depth of hypotension in millimeters of mercury be- low a MAP of 65 mm Fg» time in minutes spent below a MAP ‘0f65 mm Hg) + total duration of operation in minutes. The units for AUT are millimeters of mercury x minutes and the units {or time-weighted average are millimeters of mercury. ‘As an example, a patient undergoes a surgery that lasts 180 minutes, in which they experience 10 episodes of hypo- tension all lasting for I minute and all with a minimal MAP ‘of 60 mm Hig, The AUT = 10 minutes « (65 - 60 = 5 mm Hg under the MAP threshold of 65 mm Hg) = 10 x5 = 50mm Hg per minute. The time-weighted average = 50 mm Hg per ‘minute + 180 minutes = 0.28 mm Hig, ‘The secondary outcome measures included incidence of hypotension (the number of hypotensive events per patient), JAMA, Pubes ene FebrutyV 2020 (© 2020 American Medical Association. lights reserved. Downloaded From: httpsi/jamanetwork.com/ on 02/17/2020 esearch Preliminary Communication Figure 2, Hemodynamic Diagnostic Gulance and Treatment Protocol Interpretation Mosc tly ase: —> ‘sete a=!” Interpretation ese tely cause: —-| impaired contr? total time with hypotension, and percentage of time spent ith hypotension during surgery. To assess the rsk of over: treatment, the above-mentioned variables were also assessed for hypertension (defined as a MAP >100 mum Hg for at least 1 minute). To be able to calculate the time-weighted average for hypertension, first the area above tie curve needed to be caleulated (eFigure 4 in Supplement 2). These time and inci dence variables were also assessed post hoc forthe alarms, ‘An alarm was deemed present when the early warning sys- tem prediction value reached 85% or higher fo atleast | min- lute. An alarm ended when the value normalized (<85%) for at Jeast minute. Clinicians’ behavior regarding treatment of alarms (intervention group) and hypotension (control group) was assessed. We noted () treatment choice (le, vasopressor, fh {ds inotropes, Trendelenburg position, and decrease in anes- thetics; @) cumulative dose; and (time from alarm to start of treatment in the intervention group and from onset of hypotension to start of treatment in the control group. All alarms or hypotensive events per patient were used for this analysis. IFan alarm or hypotensive event had more than 1 {ueatment, the time to fist treatment was used. In post hoc analyses, control group clinicians’ treatment behavior after silent alarms to which they were blinded was also assessed and compared with treatment behavior ater alarms in the intervention group. We calculated () total number of silent alarms; (2) number of alarms per patient; (3) number of alarms that led to treatment; (4) number of treatments per alarm; (5) time from alarm to treatment inthe intervention JAMA Putstedcrine Feuny 172020 ecto Machine Learig-Deived Ear Warring ys vs Stand Care on Hypotension Daring Nenearac Surgery *Vasopla indicates decreased ‘sto osalartessanee Simp vertar comaciy. group compared with time from silent alarm to treatment in ‘the control group (all alarms per patient were used for this analysis; if an alarm had more than 1 treatment, the time to frst treatment was used); and (6) time from first alarm to fist treatment in the intervention group compared with ‘time from first silent alarm to first treatment in the control group. The last analysis was performed because all actions after the first alarm might be influenced by and correlated with the first alarm, ‘The feasibility of working with the hemodynamic diag nostic guidance and treatment protocol was analyzed based ‘on the numberof protocol violations. Primary and secondary end points were analyzed for the intraoperative period only Intraoperative and postoperative adverse events and serious adverse events were documented, or definitions, see eTable 3in Supplement). ‘Sample Size Calulation ‘Time-sveighted average is a relatively novel end point such ‘that only an estimation could be made of what difference ‘would be clinically relevant, Prior to the study, an expert panel familiar with the potential effect of intraoperative hypotension was consulted, and it was decided that a 75% reduction of hypotension in terms of combined depth and. 85%) chance ofhypotension oecur- ring) was triggered. In 36% (19 alarms), the anesthesiologist did not want to act on the alarm because of alarm fatigue, Je, the anesthesiologist refused to teat because ofthe fre= quency ofthe alarms. Alarm fatigue is a phenomenon de- scribed in more dealin the lterature.**Tn 26% (14 alarms), there was a temporary reason for the (predicted) hypoten son, such as hungrecrutment orbrief surgical obstruction of the vena cava In the remaining 2% (alam), the anesthes logit had a different priority, namely an airway problem. Hypertension| ‘The median time-weighted average of hypertension was 0.09 mm Hg (IOR, 0.00-0.21 mm Hg) in the intervention

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