The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial

Lopez, Marcos G.; Pretorius, Mias; Shotwell, Matthew S.; Deegan, Robert; Eagle, Susan; Bennett, Jeremy M.; Sileshi, Bantayehu; Liang, Yafen; Gelfand, Brian J.; Kingeter, Adam J.; Siegrist, Kara K.; Lombard, Frederick W.; Richburg, Tiffany M.; Fornero, Dane; Shaw, Andrew; Hernandez, Antonio; Billings, Frederic T.

doi:10.1186/s13063-017-2021-5

Cited by 22 publications

(19 citation statements)

References 32 publications

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“…To that end, we are currently conducting a clinical trial to further study this mechanism by randomly assigning cardiac surgery patients to intraoperative normoxia or hyperoxia and assessing for oxidative damage and organ injury. 50 This study has noteworthy strengths and limitations. Specifically, trained research staff prospectively collected delirium outcomes in the setting of a clinical trial; we measured markers of oxidative damage, neuronal injury, and blood-brain barrier disruption at numerous perioperative time points representing nearly 4,000 samples; and the large cohort included multiple types of cardiac surgery, increasing the generalizability of the results.…”

Section: Discussionmentioning

confidence: 96%

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Intraoperative Oxidative Damage and Delirium after Cardiac Surgery

et al. 2020

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Background Mechanisms of postoperative delirium remain poorly understood, limiting development of effective treatments. We tested the hypothesis that intraoperative oxidative damage is associated with delirium and neuronal injury and that disruption of the blood–brain barrier modifies these associations. Methods In a prespecified cohort study of 400 cardiac surgery patients enrolled in a clinical trial of atorvastatin to reduce kidney injury and delirium, we measured plasma concentrations of F2-isoprostanes and isofurans using gas chromatography-mass spectrometry to quantify oxidative damage, ubiquitin carboxyl-terminal hydrolase isozyme L1 to quantify neuronal injury, and S100 calcium-binding protein B using enzyme-linked immunosorbent assays to quantify blood–brain barrier disruption before, during, and after surgery. We performed the Confusion Assessment Method for the Intensive Care Unit twice daily to diagnose delirium. We measured the independent associations between intraoperative F2-isoprostanes and isofurans and delirium (primary outcome) and postoperative ubiquitin carboxyl-terminal hydrolase isozyme L1 (secondary outcome), and we assessed if S100 calcium-binding protein B modified these associations. Results Delirium occurred in 109 of 400 (27.3%) patients for a median (10th, 90th percentile) of 1.0 (0.5, 3.0) days. In the total cohort, plasma ubiquitin carboxyl-terminal hydrolase isozyme L1 concentration was 6.3 ng/ml (2.7, 14.9) at baseline and 12.4 ng/ml (7.9, 31.2) on postoperative day 1. F2-isoprostanes and isofurans increased throughout surgery, and the log-transformed sum of intraoperative F2-isoprostanes and isofurans was independently associated with increased odds of postoperative delirium (odds ratio, 3.70 [95% CI, 1.41 to 9.70]; P = 0.008) and with increased postoperative ubiquitin carboxyl-terminal hydrolase isozyme L1 (ratio of geometric means, 1.42 [1.11 to 1.81]; P = 0.005). The association between increased intraoperative F2-isoprostanes and isofurans and increased postoperative ubiquitin carboxyl-terminal hydrolase isozyme L1 was amplified in patients with elevated S100 calcium-binding protein B (P = 0.049). Conclusions Intraoperative oxidative damage was associated with increased postoperative delirium and neuronal injury, and the association between oxidative damage and neuronal injury was stronger among patients with increased blood–brain barrier disruption. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

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Section: Discussionmentioning

confidence: 96%

“…Four hundred patients comprised the cohort. The median (10th percentile, 90th percentile) age of patients was 67 (50,81) yr, 32.8% were female, 30.8% were diabetic, and 70.8% had CPB during surgery (table 1). One hundred-nine patients (27.3%) developed postoperative delirium for a median of 1.0 (0.5, 3.0) days.…”

Section: Patient Characteristics and Deliriummentioning

confidence: 99%

Intraoperative Oxidative Damage and Delirium after Cardiac Surgery

et al. 2020

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“…A recent meta-analysis based on 12 randomized controlled trials (RCTs) showed the minimal effect of hyperoxia on organ dysfunction, length of hospital stay, and mortality in adult cardiac surgery (26). An ongoing study is currently comparing the increase in serum creatinine in hyperoxygenated patients (FiO 2 of 100%) and those undergoing physiological oxygenation (27).…”

Section: Fio 2 Managementmentioning

confidence: 99%

Routine practice in mechanical ventilation in cardiac surgery in Italy

Bignami¹,

Lullo²,

Saglietti³

et al. 2019

J. Thorac. Dis

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Background: Management of mechanical ventilation is a key issue in the prevention of postoperative pulmonary complications (PPCs) and the improvement of surgical outcome. This is especially true in cardiac surgery where the use of the cardiopulmonary bypass (CPB) increases the risk of lung injury. In the last years a growing number of studies have shown that protective ventilation has led to excellent results. However, the literature in this regard is lacking in cardiac surgery and there are no univocal guidelines in this sense. The aim of this survey was to investigate the actual clinical practice about ventilation techniques used in the Italian cardiac surgery centers. Methods: A questionnaire of 32-item was sent to 69 Italian cardiac surgery centers, 56 of which return a completed form (81.2%). The questionnaire was assembled by three independent researchers and the final version was e-mailed to all members of the SIAARTI (Italian society of anesthesia resuscitation and intensive care medicine) Study Group on Cardiothoracic and Vascular Anesthesia. The answers were collected using a Google Forms sheet. In case of multiple questionnaires returned from the same center (i.e., different physicians from the same center responded) the head of department was asked to give a definite answer. Furthermore, for the 17 centers who reported multiple questionnaires, no large differences were found between the responses of different doctors belonging to the same center (12.3%±4.2% of discordant answers). Results: Intraoperatively, patients were ventilated with a tidal volume (TV) of 6−8 mL/kg (91.1% of centers), a positive end-expiration pressure of 3−5 cmH 2 O (76.8% of centers) and a fraction of inspired oxygen (FiO 2) of 50−80% (60.7% of centers). During the CPB, the "stop ventilation" technique was frequently adopted (73.2%). Before the discharge from the intensive care unit (ICU) non-invasive ventilation (NIV) was never applied in 32.1% of the centers, but it was used in 46.4% of patients with postoperative complications. Conclusions: This study shows a significant heterogeneity in ventilatory techniques among the Italian centers during CPB, whereas in the other surgical time the majority of the responding centers adopted a protective mechanical ventilation strategy.

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“…All these factors involve an increased risk of lung injury in thoracic surgery with OLV, ranging from mild to severe acute respiratory distress syndrome (ARDS), and, consequently, an increase of mortality and morbidity (21).…”

Section: One-lung Ventilation (Ovl)mentioning

confidence: 99%

“…The use of a normoxemia strategy did not diminish myocardial damage, nor did it influence secondary outcomes such as cardiac index, systemic vascular resistance index, creatinine, and lactate (30). Another study, aiming to compare the creatinine increase in hyperoxygenated patients (1.0 FiO 2 ) and those undergoing physiological oxygenation, is still underway (21).…”

Section: Protective Ventilation During Cardiac Surgerymentioning

confidence: 99%

Mechanical ventilation management during cardiothoracic surgery: an open challenge

Bignami¹,

Saglietti²,

Lullo³

2018

Ann. Transl. Med

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Mechanical ventilation during surgery is a highly complex procedure, particularly in cardiothoracic surgery, where patients need to undergo substantial hemodynamic management, involving large fluid exchanges and pharmacological manipulation of vascular resistance, as well as direct manipulation of the lungs themselves. Cardiothoracic surgery is burdened by a high rate of postoperative pulmonary complication (PPC), comorbidity, and mortality. Recent trials have examined various techniques to preserve lung function, although consensus on best practice has yet to be reached. This might be due to the close relationship between the circulatory and pulmonary systems. The use of a technique designed to prevent pulmonary complication might negatively impact the hemodynamics of an already critical patient. Stressinduced lung injury can occur during surgery for various reasons, some of which have yet to be fully investigated. In cardiac surgery, this damage is mainly ascribed to two events: cardiopulmonary bypass (CPB) and sternotomy. In thoracic surgery, on the other hand, overdistention and permissive hyperoxia, both routinely used on one lung to compensate for the collapse of the other, are generally to blame for lung injury. In recent years "protective" ventilation strategies have been proposed to spare lung parenchyma from stressinduced damage. Despite the growing interest in protective ventilation techniques, there are still no clear international guidelines for mechanical ventilation in cardiothoracic surgery. However, some recent progress has been made, with positive clinical outcomes.

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The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial

Cited by 22 publications

References 32 publications

Intraoperative Oxidative Damage and Delirium after Cardiac Surgery

Intraoperative Oxidative Damage and Delirium after Cardiac Surgery

Routine practice in mechanical ventilation in cardiac surgery in Italy

Mechanical ventilation management during cardiothoracic surgery: an open challenge

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