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1.
Perfusion ; : 2676591241258054, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38832503

ABSTRACT

INTRODUCTION: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. METHODS: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. RESULTS: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). CONCLUSIONS: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.

2.
J Biomed Opt ; 29(Suppl 3): S33302, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38707651

ABSTRACT

Significance: Cerebral oximeters have the potential to detect abnormal cerebral blood oxygenation to allow for early intervention. However, current commercial systems have two major limitations: (1) spatial coverage of only the frontal region, assuming that surgery-related hemodynamic effects are global and (2) susceptibility to extracerebral signal contamination inherent to continuous-wave near-infrared spectroscopy (NIRS). Aim: This work aimed to assess the feasibility of a high-density, time-resolved (tr) NIRS device (Kernel Flow) to monitor regional oxygenation changes across the cerebral cortex during surgery. Approach: The Flow system was assessed using two protocols. First, digital carotid compression was applied to healthy volunteers to cause a rapid oxygenation decrease across the ipsilateral hemisphere without affecting the contralateral side. Next, the system was used on patients undergoing shoulder surgery to provide continuous monitoring of cerebral oxygenation. In both protocols, the improved depth sensitivity of trNIRS was investigated by applying moment analysis. A dynamic wavelet filtering approach was also developed to remove observed temperature-induced signal drifts. Results: In the first protocol (28±5 years; five females, five males), hair significantly impacted regional sensitivity; however, the enhanced depth sensitivity of trNIRS was able to separate brain and scalp responses in the frontal region. Regional sensitivity was improved in the clinical study given the age-related reduction in hair density of the patients (65±15 years; 14 females, 13 males). In five patients who received phenylephrine to treat hypotension, different scalp and brain oxygenation responses were apparent, although no regional differences were observed. Conclusions: The Kernel Flow has promise as an intraoperative neuromonitoring device. Although regional sensitivity was affected by hair color and density, enhanced depth sensitivity of trNIRS was able to resolve differences in scalp and brain oxygenation responses in both protocols.


Subject(s)
Cerebrovascular Circulation , Spectroscopy, Near-Infrared , Humans , Spectroscopy, Near-Infrared/methods , Spectroscopy, Near-Infrared/instrumentation , Female , Male , Adult , Cerebrovascular Circulation/physiology , Hemodynamics/physiology , Oximetry/methods , Oximetry/instrumentation , Oxygen/blood , Oxygen/metabolism , Brain/diagnostic imaging , Brain/blood supply , Equipment Design
3.
Heart Vessels ; 38(7): 964-974, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36723766

ABSTRACT

Literature regarding monitoring and consequences of distal limb ischemia due to femoral artery cannulation for Minimally Invasive Cardiac Surgery (MICS) remains limited. The primary objective was to determine its incidence, defined as a ≥ 15% difference in regional Oxygen Saturation (rSO2) lasting ≥ four consecutive minutes between the cannulated and non-cannulated limb. The secondary objectives included: determination of distal limb ischemia, defined as a Tissue Oxygenation Index (TOI) < 50% in the cannulated limb, identification of predictors for distal limb ischemia, determination of a possible association of NIRS-diagnosed ischemia with acute kidney injury, and the need for vascular surgery up to six months after cardiac surgery. A prospective, observational cohort study with blinded rSO2-measurements to prevent intraoperative clinical decision-making. A single-center, community-hospital, clinical study. All consecutive patients ≥ 18 years old, and scheduled for predefined MICS. Patients underwent MICS with bilateral calf muscle rSO2-measurements conducted by Near-Infrared Spectroscopy (NIRS). In total 75/280 patients (26.79%) experienced distal limb ischemia according to the primary objective, while 18/280 patients (6.42%) experienced distal limb ischemia according to the secondary objective. Multivariate logistic regression showed younger age to be an independent predictor for distal limb ischemia (p = 0.003). None of the patients who suffered intraoperative ischemia required vascular surgery within the follow-up period. The incidence of NIRS-diagnosed ischemia varied from 6.4% to 26.8% depending on the used criteria. Short and long-term vascular sequelae, however, are limited and not intraoperative ischemia related. The added value of intraoperative distal limb NIRS monitoring for vascular reasons seems limited. Future research on femoral artery cannulation in MICS should shift focus to other outcome parameters such as acute kidney injury, postoperative pain or paresthesias.


Subject(s)
Acute Kidney Injury , Arterial Occlusive Diseases , Cardiac Surgical Procedures , Humans , Adolescent , Femoral Artery/surgery , Prospective Studies , Incidence , Catheterization/adverse effects , Ischemia/diagnosis , Ischemia/epidemiology , Ischemia/etiology , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Retrospective Studies
4.
Metabolites ; 12(9)2022 Aug 31.
Article in English | MEDLINE | ID: mdl-36144221

ABSTRACT

Near-infrared spectroscopy (NIRS) measurements of tissue oxygen saturation (StO2) are frequently used during vascular and cardiac surgeries as a non-invasive means of assessing brain health; however, signal contamination from extracerebral tissues remains a concern. As an alternative, hyperspectral (hs)NIRS can be used to measure changes in the oxidation state of cytochrome c oxidase (ΔoxCCO), which provides greater sensitivity to the brain given its higher mitochondrial concentration versus the scalp. The purpose of this study was to evaluate the depth sensitivity of the oxCCO signal to changes occurring in the brain and extracerebral tissue components. The oxCCO assessment was conducted using multi-distance hsNIRS (source-detector separations = 1 and 3 cm), and metabolic changes were compared to changes in StO2. Ten participants were monitored using an in-house system combining hsNIRS and diffuse correlation spectroscopy (DCS). Data were acquired during carotid compression (CC) to reduce blood flow and hypercapnia to increase flow. Reducing blood flow by CC resulted in a significant decrease in oxCCO measured at rSD = 3 cm but not at 1 cm. In contrast, significant changes in StO2 were found at both distances. Hypercapnia caused significant increases in StO2 and oxCCO at rSD = 3 cm, but not at 1 cm. Extracerebral contamination resulted in elevated StO2 but not oxCCO after hypercapnia, which was significantly reduced by applying regression analysis. This study demonstrated that oxCCO was less sensitive to extracerebral signals than StO2.

6.
Anesthesiology ; 135(1): 83-94, 2021 07 01.
Article in English | MEDLINE | ID: mdl-33930115

ABSTRACT

BACKGROUND: Evoked potential monitoring is believed to prevent neurologic injury in various surgical settings; however, its clinical effect has not been scrutinized. It was hypothesized that an automated nerve monitor can minimize intraoperative nerve injury and thereby improve clinical outcomes in patients undergoing shoulder arthroplasty. METHODS: A prospective, blinded, parallel group, superiority design, single-center, randomized controlled study was conducted. Study participants were equally randomized into either the automated nerve-monitored or the blinded monitored groups. The primary outcome was intraoperative nerve injury burden as assessed by the cumulative duration of nerve alerts. Secondary outcomes were neurologic deficits and functional scores of the operative arm, and the quality of life index (Euro Quality of life-5 domain-5 level score) at postoperative weeks 2, 6, and 12. RESULTS: From September 2018 to July 2019, 213 patients were screened, of whom 200 were randomized. There was no statistically significant difference in the duration of nerve alerts between the automated nerve-monitored and control groups (median [25th, 75th interquartile range]: 1 [0, 18] and 5 [0, 26.5]; Hodges-Lehman difference [95% CI]: 0 [0 to 1] min; P = 0.526). There were no statistically significant differences in secondary outcomes between groups. However, in the ancillary analysis, there were reductions in neurologic deficits and improvements in quality of life index occurring in both groups over the course of the study period. CONCLUSIONS: Protection from nerve injury is a shared responsibility between surgeons and anesthesiologists. Although a progressive improvement of clinical outcomes were observed over the course of the study in both groups as a consequence of the real-time feedback provided by the automated nerve monitor, this trial did not demonstrate that automated nerve monitoring by itself changes important clinical outcomes compared with no monitoring.


Subject(s)
Arthroplasty, Replacement, Shoulder , Monitoring, Intraoperative/methods , Peripheral Nerve Injuries/prevention & control , Aged , Female , Humans , Male , Prospective Studies , Single-Blind Method
7.
Biomed Opt Express ; 11(10): 5967-5981, 2020 Oct 01.
Article in English | MEDLINE | ID: mdl-33149999

ABSTRACT

During cardiac surgery with cardiopulmonary bypass (CPB), adequate maintenance of cerebral blood flow (CBF) is vital in preventing postoperative neurological injury - i.e. stroke, delirium, cognitive impairment. Reductions in CBF large enough to impact cerebral energy metabolism can lead to tissue damage and subsequent brain injury. Current methods for neuromonitoring during surgery are limited. This study presents the clinical translation of a hybrid optical neuromonitor for continuous intraoperative monitoring of cerebral perfusion and metabolism in ten patients undergoing non-emergent cardiac surgery with non-pulsatile CPB. The optical system combines broadband near-infrared spectroscopy (B-NIRS) to measure changes in the oxidation state of cytochrome c oxidase (oxCCO) - a direct marker of cellular energy metabolism - and diffuse correlation spectroscopy (DCS) to provide an index of cerebral blood flow (CBFi). As the heart was arrested and the CPB-pump started, increases in CBFi (88.5 ± 125.7%) and significant decreases in oxCCO (-0.5 ± 0.2 µM) were observed; no changes were noted during transitions off CPB. Fifteen hypoperfusion events, defined as large and sustained reductions in CPB-pump flow rate, were identified across all patients and resulted in significant decreases in perfusion and metabolism when mean arterial pressure dropped to 30 mmHg or below. The maximum reduction in cerebral blood flow preceded the corresponding metabolic reduction by 18.2 ± 15.0 s. Optical neuromonitoring provides a safe and non-invasive approach for assessing intraoperative perfusion and metabolism and has potential in guiding patient management to prevent adverse clinical outcomes.

8.
J Thorac Dis ; 11(Suppl 10): S1489-S1491, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31293798

ABSTRACT

In this review the impact of cardiopulmonary bypass (CPB) on the microcirculation is discussed. The impact of conventional non-pulsatile perfusion is contrasted with the microcirculatory impact of pulsatile CPB which is associated with better preservation of microcirculatory function. Evidence that alterations in microcirculatory function that persist following cardiac surgery are associated with adverse clinical outcomes is reviewed. Recent studies using novel techniques employing near infrared reflectance spectroscopy (NIRS) and sublingual microscopy to explore alterations in microcirculatory function during CPB are reviewed and the implications of these observations for studies investigating minimally invasive extracorporeal circulation (MiECC) are discussed.

9.
J Neurosurg Anesthesiol ; 31(3): 291-298, 2019 Jul.
Article in English | MEDLINE | ID: mdl-29787402

ABSTRACT

INTRODUCTION: Peripheral nerve injury is a potentially devastating complication after total shoulder arthroplasty (TSA) surgery. This pilot study aimed to assess the feasibility of using an automated somatosensory evoked potential (SSEP) device to provide a timely alert/intervention to minimize intraoperative nerve insults during TSA surgery. METHODS: A prospective, single-arm, observational study was conducted in a single university hospital. The attending anesthesiologist monitored the study participants using the EPAD automated SSEP device and an intervention was made if there was an alert during TSA surgery. The median, radial, and ulnar nerve SSEP on the operative arm, as well as the median nerve SSEP of the nonoperative arm were monitored for each patient. All patients were evaluated for postoperative neurological deficits 6 weeks postoperatively. RESULTS: In total, 21 patients were consented and were successfully monitored. In total, 4 (19%) patients developed intraoperative abnormal SSEP signal changes in the operative arm, in which 3 were reversible and 1 was irreversible till the end of surgery. Median and radial nerves were mostly involved (3/4 patients). The mean cumulative duration of nerve insult (abnormal SSEP) was 21.7±26.2 minutes. Univariate analysis did not identify predictor of intraoperative nerve insults. No patients demonstrated postoperative peripheral neuropathy at 6 weeks. CONCLUSIONS: A high incidence (19%) of intraoperative nerve insult was observed in this study demonstrating the feasibility of using an automated SSEP device to provide a timely alert and enable an intervention in order to minimize peripheral nerve injury during TSA. Further randomized studies are warranted.


Subject(s)
Arthroplasty, Replacement, Shoulder/methods , Electroencephalography/instrumentation , Evoked Potentials, Somatosensory , Intraoperative Complications/prevention & control , Intraoperative Neurophysiological Monitoring/instrumentation , Intraoperative Neurophysiological Monitoring/methods , Peripheral Nerve Injuries/prevention & control , Aged , Aged, 80 and over , Arm/innervation , Female , Humans , Intraoperative Complications/diagnosis , Male , Median Nerve/injuries , Median Nerve/physiopathology , Middle Aged , Peripheral Nerve Injuries/diagnosis , Pilot Projects , Prospective Studies , Radial Nerve/injuries , Radial Nerve/physiopathology , Ulnar Nerve/injuries , Ulnar Nerve/physiopathology
10.
BMJ Open ; 8(7): e021521, 2018 07 06.
Article in English | MEDLINE | ID: mdl-29982215

ABSTRACT

OBJECTIVES: Covert stroke after non-cardiac surgery may have substantial impact on duration and quality of life. In non-surgical patients, covert stroke is more common than overt stroke and is associated with an increased risk of cognitive decline and dementia. Little is known about covert stroke after non-cardiac surgery.NeuroVISION is a multicentre, international, prospective cohort study that will characterise the association between perioperative acute covert stroke and postoperative cognitive function. SETTING AND PARTICIPANTS: We are recruiting study participants from 12 tertiary care hospitals in 10 countries on 5 continents. PARTICIPANTS: We are enrolling patients ≥65 years of age, requiring hospital admission after non-cardiac surgery, who have an anticipated length of hospital stay of at least 2 days after elective non-cardiac surgery that occurs under general or neuraxial anaesthesia. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients are recruited before elective non-cardiac surgery, and their cognitive function is measured using the Montreal Cognitive Assessment (MoCA) instrument. After surgery, a brain MRI study is performed between postoperative days 2 and 9 to determine the presence of acute brain infarction. One year after surgery, the MoCA is used to assess postoperative cognitive function. Physicians and patients are blinded to the MRI study results until after the last patient follow-up visit to reduce outcome ascertainment bias.We will undertake a multivariable logistic regression analysis in which the dependent variable is the change in cognitive function 1 year after surgery, and the independent variables are acute perioperative covert stroke as well as other clinical variables that are associated with cognitive dysfunction. CONCLUSIONS: The NeuroVISION study will characterise the epidemiology of covert stroke and its clinical consequences. This will be the largest and the most comprehensive study of perioperative stroke after non-cardiac surgery. TRIAL REGISTRATION NUMBER: NCT01980511; Pre-results.


Subject(s)
Cognitive Dysfunction/physiopathology , Length of Stay/statistics & numerical data , Postoperative Complications/physiopathology , Stroke/physiopathology , Surgical Procedures, Operative/adverse effects , Aged , Cognition , Cognitive Dysfunction/diagnostic imaging , Cognitive Dysfunction/etiology , Female , Humans , Magnetic Resonance Imaging , Male , Perioperative Period , Postoperative Complications/diagnostic imaging , Prospective Studies , Stroke/diagnostic imaging
11.
Anesth Analg ; 127(1): 134-143, 2018 07.
Article in English | MEDLINE | ID: mdl-29787414

ABSTRACT

Perioperative peripheral nerve injury (PNI) is a well-recognized complication of general anesthesia that continues to result in patient disability and malpractice claims. However, the multifactorial etiology of PNI is often not appreciated in malpractice claims given that most PNI is alleged to be due to errors in patient positioning. New advances in monitoring may aid anesthesiologists in the early detection of PNI. This article reviews recent studies of perioperative PNI after general anesthesia and discusses the epidemiology and potential mechanisms of injury and preventive measures. We performed a systematic literature search, reviewed the available evidence, and identified areas for further investigation. We also reviewed perioperative PNI in the Anesthesia Closed Claims Project database for adverse events from 1990 to 2013. The incidence of perioperative PNI after general anesthesia varies considerably depending on the type of surgical procedure, the age and risk factors of the patient population, and whether the detection was made retrospectively or prospectively. Taken together, studies suggest that the incidence in a general population of surgical patients undergoing all types of procedures is <1%, with higher incidence in cardiac, neurosurgery, and some orthopedic procedures. PNI represent 12% of general anesthesia malpractice claims since 1990, with injuries to the brachial plexus and ulnar nerves representing two-thirds of PNI claims. The causes of perioperative PNI after general anesthesia are likely multifactorial, resulting in a "difficult to predict and prevent" phenomenon. Nearly half of the PNI closed claims did not have an obvious etiology, and most (91%) were associated with appropriate anesthetic care. Future studies should focus on the interaction between different mechanisms of insult, severity and duration of injury, and underlying neuronal reserves. Recent automated detection technology in neuromonitoring with somatosensory evoked potentials may increase the ability to identify at-risk patients and individualize patient management.


Subject(s)
Anesthesia, General/adverse effects , Peripheral Nerve Injuries , Peripheral Nerves/physiopathology , Humans , Incidence , Intraoperative Neurophysiological Monitoring , Neurologic Examination , Perioperative Period , Peripheral Nerve Injuries/diagnosis , Peripheral Nerve Injuries/epidemiology , Peripheral Nerve Injuries/physiopathology , Peripheral Nerve Injuries/prevention & control , Predictive Value of Tests , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
12.
Ann Thorac Surg ; 105(6): 1745-1753, 2018 06.
Article in English | MEDLINE | ID: mdl-29391150

ABSTRACT

BACKGROUND: Pulsatile perfusion may offer microcirculatory advantages over conventional nonpulsatile perfusion during cardiopulmonary bypass (CPB). Here, we present direct visual evidence of microvascular perfusion and vasoreactivity between perfusion modalities. METHODS: A prospective, randomized cohort study of 20 high-risk cardiac surgical patients undergoing pulsatile (n = 10) or nonpulsatile (n = 10) flow during CPB was conducted. Changes in sublingual mucosal microcirculation were assessed with orthogonal polarization spectral imaging along with near-infrared spectroscopic indices of thenar muscle tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test at the following time points: baseline (T0), 30 minutes on CPB (T1), 90 minutes on CPB (T2), 1 hour after CPB (T3), and 24 hours after CPB (T4). RESULTS: On the basis of our scoring scale, a shift in microcirculatory blood flow occurred over time. The pulsatile group maintained normal perfusion characteristics, whereas the nonpulsatile group exhibited deterioration in perfusion during CPB (T2: 74.0% ± 5.6% versus 57.6% ± 5.0%) and after CPB (T3: 76.2% ± 2.7% versus 58.9% ± 5.2%, T4: 85.7% ± 2.6% versus 69.8% ± 5.9%). Concurrently, no important differences were found between groups in baseline StO2 and consumption slope at all time points. Reperfusion slope was substantially different between groups 24 hours after CPB (T4: 6.1% ± 0.6% versus 3.7% ± 0.5%), indicating improved microvascular responsiveness in the pulsatile group versus the nonpulsatile group. CONCLUSIONS: Pulsatility generated by the roller pump during CPB improves microcirculatory blood flow and tissue oxygen saturation compared with nonpulsatile flow in high-risk cardiac surgical patients, which may reflect attenuation of the systemic inflammatory response and ischemia-reperfusion injury.


Subject(s)
Cardiac Surgical Procedures/methods , Cardiopulmonary Bypass/methods , Microcirculation/physiology , Pulsatile Flow , Age Factors , Aged , Aged, 80 and over , Cardiac Surgical Procedures/mortality , Cardiopulmonary Bypass/adverse effects , Cardiopulmonary Bypass/mortality , Female , Hemodynamics/physiology , Humans , Male , Middle Aged , Oxygen Consumption/physiology , Prognosis , Prospective Studies , Risk Assessment , Sex Factors , Spectroscopy, Near-Infrared , Treatment Outcome
13.
J Cardiothorac Vasc Anesth ; 31(4): 1174-1182, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28159523

ABSTRACT

OBJECTIVE: Peripheral nerve injury (PNI) is a common and potentially devastating complication in cardiac surgery. Somatosensory evoked potential (SSEP) monitoring is one of the modalities for PNI; however, its application is limited by complicated logistics. This study aimed to assess the feasibility of using a novel, automated SSEP device (EPAD; SafeOp Surgical, Hunt Valley, MD) for detection of intraoperative PNI during cardiac surgery. DESIGN: Prospective, observational study. SETTING: Single university hospital. PARTICIPANTS: Cardiac surgical patients. INTERVENTIONS: After Ethics Board approval and written consent, study participants were monitored using the EPAD automated SSEP device during cardiac surgery. All patients with prolonged and abnormal SSEP changes were evaluated postoperatively, and if they were symptomatic, they were referred for further nerve conduction and electromyographic assessment. MEASUREMENTS AND MAIN RESULTS: Of the 43 patients who consented to study inclusion, 33 were monitored successfully. With increasing clinical experience the authors encountered minimal technical issues, and satisfactory signals were obtained in most patients. Abnormal SSEP signal changes, which were encountered in 5 (15.2%) patients, were interpreted as impending PNI; 3 patients experienced prolonged signal changes (>1 h), and 2 (6.1%) of these developed symptomatic peripheral neuropathy that was confirmed with nerve conduction studies. CONCLUSIONS: The EPAD automated SSEP device is a viable option for detecting PNI during cardiac surgery. A high incidence of intraoperative peripheral nerve compromise and a 6.1% incidence of postoperative peripheral neuropathy were observed. This study reports the clinical feasibility of using the EPAD automated SSEP device; additional studies are required to evaluate the diagnostic test accuracy and the outcome benefit of routine SSEP monitoring in cardiac surgical patients.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Evoked Potentials, Somatosensory/physiology , Intraoperative Neurophysiological Monitoring/methods , Peripheral Nerve Injuries/diagnosis , Peripheral Nerve Injuries/physiopathology , Aged , Feasibility Studies , Female , Humans , Intraoperative Neurophysiological Monitoring/instrumentation , Male , Middle Aged , Peripheral Nerve Injuries/etiology , Prospective Studies
14.
Can J Anaesth ; 63(10): 1128-1139, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27465213

ABSTRACT

PURPOSE: Volatile anesthetics possess cardioprotective properties, but it is unknown if the cardioprotective effects extend equally to all members of the class. Although sevoflurane is a relatively newer anesthetic than isoflurane, its introduction into practice was not preceded by a head-to-head comparison with isoflurane in a trial focusing on clinically important outcomes. Our objective was to determine whether sevoflurane was non-inferior to isoflurane on a clinically important primary outcome in a heterogeneous group of adults undergoing cardiac surgery. METHODS: This was a pragmatic randomized non-inferiority comparative effectiveness clinical trial in 464 adults having coronary artery bypass graft and/or single valve surgery during November 2011 to March 2014. The intervention was maintenance of anesthesia with sevoflurane (n = 231) or isoflurane (n = 233) administered at a dose of 0.5-2.0 MAC throughout the entire operation. All caregivers were blinded except for the anesthesiologist and perfusionist. The primary outcome was a composite of intensive care unit (ICU) length of stay ≥ 48 hr and all-cause 30-day mortality. We hypothesized that sevoflurane would be non-inferior to isoflurane (non-inferiority margin < 10% based on an expected event rate of 25%). Secondary outcomes included prolonged ICU stay, 30- and 365-day all-cause mortality, inotrope or vasopressor usage, new-onset hemodialysis or atrial fibrillation, stroke, and readmission to the ICU. RESULTS: No losses to follow-up occurred. The primary outcome occurred in 25% of sevoflurane patients and 30% of isoflurane patients (absolute difference, -5.4%; one-sided 95% confidence interval, 1.4), thus non-inferiority was declared. Sevoflurane was not superior to isoflurane for the primary outcome (P = 0.21) or for any secondary outcomes. CONCLUSION: Sevoflurane is non-inferior to isoflurane on a composite outcome of prolonged ICU stay and all-cause 30-day mortality. Sevoflurane is not superior to isoflurane on any other of the clinically important outcomes. This trial was registered at clinicaltrials.gov; NCT01477151.


RéSUMé: OBJECTIF: Les agents anesthésiques volatils possèdent des propriétés cardioprotectrices, mais nous ne savons pas si ces effets cardioprotecteurs sont équivalents pour tous les agents de cette classe. Bien que le sévoflurane soit un anesthésique plus récent que l'isoflurane, son introduction dans notre pratique n'a pas été précédée par une comparaison directe à l'isoflurane dans une étude s'intéressant à d'importants critères d'évaluation cliniques. Notre objectif était de déterminer si le sévoflurane était non inférieur à l'isoflurane en relation à un critère d'évaluation principal important d'un point de vue clinique dans un groupe hétérogène d'adultes subissant une chirurgie cardiaque. MéTHODE: Nous avons réalisé une étude clinique randomisée et pragmatique d'efficacité comparative et de non-infériorité auprès de 464 adultes subissant des pontages coronariens et/ou une chirurgie valvulaire unique entre novembre 2011 et mars 2014. L'intervention consistait en le maintien de l'anesthésie à l'aide de sévoflurane (n = 231) ou d'isoflurane (n = 233) administré à une dose de 0,5-2,0 MAC tout au long de l'opération. Aucun intervenant ne connaissait l'agent utilisé, à l'exception de l'anesthésiologiste et du perfusionniste. Le critère d'évaluation principal était une composée de la durée de séjour à l'unité de soins intensifs (USI) ≥ 48 h et de la mortalité, toutes causes confondues, à 30 jours. Nous avons émis l'hypothèse que le sévoflurane ne serait pas inférieur à l'isoflurane (marge de non-infériorité < 10 % sur la base d'un taux de complications attendu de 25 %). Les critères d'évaluation secondaires comprenaient un séjour prolongé à l'USI, la mortalité toutes causes confondues à 30 et à 365 jours, l'utilisation d'inotropes ou de vasopresseurs, une hémodialyse ou une fibrillation auriculaire nouvelles, un accident vasculaire cérébral et une réadmission à l'USI. RéSULTATS: Nous n'avons perdu aucun patient au suivi. Le critère d'évaluation principal est survenu chez 25 % des patients ayant reçu du sévoflurane et 30 % des patients ayant reçu de l'isoflurane (différence absolue, −5,4 %; intervalle de confiance unilatéral 95 %, 1,4): la non-infériorité a donc été déclarée. Le sévoflurane n'était pas supérieur à l'isoflurane en ce qui touchait au critère d'évaluation principal (P = 0,21) ou aux critères d'évaluation secondaires. CONCLUSION: Le sévoflurane n'est pas inférieur à l'isoflurane selon un critère d'évaluation composé d'une durée de séjour prolongée à l'USI et de la mortalité toutes causes confondues à 30 jours. Le sévoflurane n'est pas supérieur à l'isoflurane en ce qui touche à n'importe quel autre critère clinique important. Cette étude a été enregistrée au ClinicalTrials.gov, numéro NCT01477151.


Subject(s)
Anesthetics, Inhalation , Cardiac Surgical Procedures/methods , Isoflurane/therapeutic use , Methyl Ethers/therapeutic use , Adult , Aged , Cardiac Surgical Procedures/mortality , Cardiotonic Agents/therapeutic use , Comparative Effectiveness Research , Coronary Artery Bypass/methods , Critical Care/statistics & numerical data , Female , Humans , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Patient Readmission , Renal Dialysis , Sevoflurane , Treatment Outcome , Vasoconstrictor Agents/therapeutic use
16.
J Clin Monit Comput ; 30(1): 41-50, 2016 Feb.
Article in English | MEDLINE | ID: mdl-25750016

ABSTRACT

Tissue microcirculation measured by vascular occlusion test is impaired during septic shock. However, it has not been investigated extensively during anesthesia induction. The aim of the study is to evaluate tissue microcirculation during anesthesia induction. We hypothesized that during anesthesia induction, tissue microcirculation measured by vascular occlusion test might be enhanced with peripheral vasodilation during anesthesia induction. We conducted a prospective observational study of 50 adult patients undergoing cardiac surgery. During anesthesia induction, we measured and analyzed tissue oxygen saturation, vascular occlusion test, cerebral oximetry, forearm-minus-fingertip skin temperature gradients and hemodynamic data in order to evaluate microcirculation as related to alterations in peripheral vasodilation as reflected by increased Tforearm-finger thermal gradients. During anesthesia induction, recovery slope during vascular occlusion test and cerebral oxygen saturation increased from 4.0 (1.5) to 4.7 (1.3) % s(-1) (p = 0.02) and 64.0 (10.2) to 74.2 (9.2) % (p < 0.001), respectively. Forearm-minus-fingertip skin temperature gradients decreased from 1.9 (2.9) to -1.4 (2.2) °C (p < 0.001). There was an inverse correlation between changes in the skin temperature gradients and changes in cerebral oximetry (r = 0.33; p = 0.02). During anesthesia induction, blood pressure and forearm-minus-fingertip skin temperature gradients decrease while cerebral oximetry and vascular occlusion test recovery slope increase. These findings suggest that anesthesia induction increases tissue microcirculation with peripheral vasodilation.


Subject(s)
Anesthetics, General/administration & dosage , Cardiac Surgical Procedures/methods , Microcirculation/drug effects , Monitoring, Intraoperative/methods , Oximetry/methods , Spectroscopy, Near-Infrared/methods , Anesthesia, General/methods , Female , Humans , Male , Middle Aged , Reproducibility of Results , Sensitivity and Specificity
17.
J Cardiothorac Vasc Anesth ; 29(5): 1187-93, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26384626

ABSTRACT

OBJECTIVE: This was a pilot study comparing the ability of a new ultrasound-tagged near-infrared (UT-NIR) device to detect cerebral autoregulation (CA) in comparison to transcranial Doppler (TCD). DESIGN: An unblinded, prospective, clinical feasibility study. SETTING: Tertiary-care university hospital cardiac surgical operating rooms. PARTICIPANTS: Twenty adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). INTERVENTIONS: There were no clinical interventions based on study monitoring devices, but a continuous correlation analysis of digital data from transcranial Doppler (TCD) velocity was compared with a novel UT-NIR device and correlation analysis of change signals versus mean arterial pressure was performed in order to detect presence or absence of intact CA and for determination of the lower limit of cerebral autoregulation during CPB. MEASUREMENTS AND MAIN RESULTS: Similar and highly significant concordance (κ = 1.00; p<0.001) was demonstrated between the 2 methodologies for determination of CA, indicating good correlation between the 2 methodologies. Intact CA was absent in 2 patients during CPB, and both devices were able to detect this. CONCLUSIONS: To the authors' knowledge this is the first clinical report of a UT-NIR device that shows promise as a clinically useful modality for detection of CA and the lower limit of cerebral autoregulation. The utility of UT-NIR was demonstrated further during times at which extensive usage of electrocautery or functional absence of the transcranial window rendered TCD uninterpretable.


Subject(s)
Cardiopulmonary Bypass , Cerebrovascular Circulation/physiology , Homeostasis/physiology , Monitoring, Intraoperative/methods , Spectroscopy, Near-Infrared/methods , Ultrasonography, Doppler, Transcranial/methods , Aged , Blood Flow Velocity/physiology , Cardiac Surgical Procedures , Feasibility Studies , Female , Humans , Male , Middle Aged , Pilot Projects , Prospective Studies
18.
Crit Care ; 19: 316, 2015 Sep 04.
Article in English | MEDLINE | ID: mdl-26337035

ABSTRACT

INTRODUCTION: Microvascular reactivity is decreased in patients with septic shock; this is associated with worse clinical outcomes. The objectives of the present study were to investigate microvascular reactivity in cardiac surgery patients and to assess any association with clinical outcomes. METHODS: We retrospectively analyzed a prospectively collected registry. In total, 254 consecutive adult patients undergoing cardiac and thoracic aortic surgeries from January 2013 through May 2014 were analyzed. We performed a vascular occlusion test (VOT) by using near-infrared spectroscopy to measure microvascular reactivity. VOT was performed three times per patient: prior to the induction of anesthesia, at the end of surgery, and on postoperative day 1. The primary endpoint was a composite of major adverse complications, including death, myocardial infarction, acute kidney injury, acute respiratory distress syndrome, and persistent cardiogenic shock. RESULTS: VOT recovery slope decreased during the surgery. VOT recovery slope on postoperative day 1 was significantly lower in patients with composite complications than those without (3.1 ± 1.6 versus 4.0 ± 1.5%/s, P = 0.001), although conventional hemodynamic values, such as cardiac output and blood pressure, did not differ between the groups. On multivariable regression and linear analyses, low VOT recovery slope on postoperative day 1 was associated with increases of composite complications (odds ratio 0.742; 95% confidence interval (CI) 0.584 to 0.943; P = 0.015) and hospital length of stay (regression coefficient (B) -1.276; 95% CI -2.440 to -0.112; P = 0.032). CONCLUSION: Microvascular reactivity largely recovered on postoperative day 1 in the patients without composite complications, but this restoration was attenuated in patients with composite complications. TRIAL REGISTRATION: ClinicalTrials.gov NCT01713192. Registered 22 October 2012.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Microvessels/physiopathology , Aged , Cardiopulmonary Bypass/adverse effects , Female , Humans , Male , Microcirculation/physiology , Middle Aged , Perioperative Period , Postoperative Period , Retrospective Studies , Treatment Outcome
20.
J Crit Care ; 30(2): 315-20, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25434719

ABSTRACT

PURPOSE: Tissue oxygen saturation (StO2) is a noninvasive measure that reflects changes in tissue perfusion. Rapid response teams (RRTs) assess sick inpatients to determine need for intensive care unit (ICU) admission. This determination is subjective based on parameters such as systolic blood pressure, heart rate, and pulse oximetry. Our objective was to determine if parameters readily available at RRT bedside assessment (vital signs and StO2) can predict ICU admission and inhospital mortality. MATERIALS AND METHODS: All inpatients assessed by RRT at a tertiary Canadian hospital were consecutively sampled for 3 months. After clinical assessment, the RRT physician (blinded to StO2) made the ultimate ICU admission decision. RESULTS: In 134 included patients, mean age was 65.5 ± 15.2 years, and 53% (n = 71) were males. There were 49 ICU admissions (36.6%) and 31 mortalities (23.1%). Two multivariable models significantly predicted ICU admission and inhospital mortality. The only independent predictor of ICU admission was pulse oximetry (adjusted odds ratio, 0.88; 95% confidence interval, 0.80-0.96; P = .007). Tissue oxygen saturation did not predict ICU admission but was the only independent predictor of mortality (adjusted odds ratio, 1.06; 95% confidence interval, 1.01-1.12; P = .04). CONCLUSIONS: Tissue oxygen saturation may identify critical illness in patients who would not traditionally meet ICU admission criteria and thus may identify patients who benefit from closer monitoring.


Subject(s)
Critical Illness , Hospital Rapid Response Team , Hospitalization , Intensive Care Units , Oximetry , Aged , Aged, 80 and over , Canada , Female , Heart Rate , Hospital Mortality , Humans , Male , Middle Aged , Risk , Tertiary Care Centers
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