scholarly journals Scheduled Prophylactic 6-Hourly IV AcetaminopheN to Prevent Postoperative Delirium in Older CaRdiac SurgicAl Patients (PANDORA): protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044346
Author(s):  
Tanvi Khera ◽  
Pooja A Mathur ◽  
Valerie M Banner-Goodspeed ◽  
Shilpa Narayanan ◽  
Marie Mcgourty ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Postoperative Delirium ◽  
Medical Center ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Cerebral Oximetry ◽  
Surgical Patients ◽  
Analgesic Consumption ◽  
Lengths Of Stay ◽  
Pain Scores

IntroductionPostoperative delirium is common among older cardiac surgery patients. Often difficult to predict and address prophylactically, delirium complicates the postoperative course by increasing morbidity and mortality as well as prolonging both hospital and intensive care unit (ICU) lengths of stay. Based on our pilot trial, we intend to study the effect of scheduled 6-hourly acetaminophen administration for 48 hours post-cardiac surgery with cardiopulmonary bypass (CPB) on the incidence of in-hospital delirium and long-term neurocognitive outcomes. Additionally, effect on duration and severity of delirium, rescue analgesic consumption, acute and chronic pain scores and lengths of hospital and ICU stay will also be explored.Methods and analysisThis multicentre, randomised, placebo-controlled, quadruple-blinded trial will include 900 older (>60 years) cardiac surgical patients requiring CPB. Patients meeting the inclusion criteria and not meeting any exclusion criteria will be enrolled at seven centres across the USA with Beth Israel Deaconess Medical Center (BIDMC), Boston, as the central coordinating centre. Additional sites may be included to broaden or speed accrual. The primary outcome measure is the incidence of in-hospital delirium till day 30. Secondary outcomes include the duration and severity of in-hospital delirium, hospital and ICU lengths of stay, postoperative pain scores, postoperative rescue analgesic consumption, postoperative cognitive function and chronic sternal pain. Creation of a biorepository and the use of intraoperative-blinded electroencephalogram (EEG) and cerebral oximetry data will support exploratory endpoints to determine mechanistic predictors of postoperative delirium.Ethics and disseminationThis trial is approved and centrally facilitated by the Institutional Review Board at BIDMC. An independent Data Safety and Monitoring Board is responsible for maintaining safety oversight. Protocol # 2019 P00075, V.1.4 (dated 20 October 2020).Trial registration numberNCT04093219.

scholarly journals Identification of Risk Factors for Delirium, Cognitive Decline, And Dementia After Cardiac Surgery (FINDERI - Find Delirium Risk Factors): A Study Protocol of A Prospective Monocentric Observational Pilot Trial

2021 ◽  
Author(s):  
Monika Sadlonova ◽  
Jonathan Vogelgsang ◽  
Claudia Lange ◽  
Irina Günther ◽  
Adriana Wiesent ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiac Surgery ◽  
Cognitive Decline ◽  
Postoperative Delirium ◽  
Medical Center ◽  
Pilot Trial ◽  
Screening Questionnaire ◽  
Standard Assessment ◽  
University Of Göttingen ◽  
The University

Abstract BACKGROUND: Postoperative delirium is a common complication of cardiac surgery associated with higher morbidity, longer hospital stay, risk of cognitive decline, dementia, and mortality. Geriatric patients, patients undergoing cardiac surgery, and intensive care patients are at a high risk of developing a postoperative delirium. A gold standard assessment or biomarkers to predict risk factors for delirium, cognitive decline, and dementia in patients undergoing cardiac surgery are not yet available. METHODS: The FINDERI trial (FINd DElirium RIsk factors) is a prospective, single-center, observational pilot study. In total, 500 patients aged ≥ 50 years undergoing cardiac surgery at the Department of Cardiovascular and Thoracic Surgery of the University of Göttingen Medical Center will be recruited. Our primary aims are to validate a delirium screening questionnaire and to identify specific preoperative risk factors and perioperative exposition factors for postoperative delirium, cognitive decline, and accelerated dementia after cardiac surgery. Our secondary aim is to identify blood-based biomarkers that predict the incidence of postoperative delirium, cognitive decline, or dementia in the context of cardiac surgery. CONCLUSION: This prospective, observational pilot trial might help to identify pre- and perioperative risk factors and biomarkers for postoperative delirium, cognitive decline, and dementia. The predictive value of a delirium screening questionnaire in cardiac surgery might also be revealed.TRIAL REGISTRATION: Ethics approval for this study was obtained from the IRB of the University of Göttingen Medical Center. The investigators registered this study in German Clinical Trials Register (DRKS) (DRKS00025095) on April, 19th 2021 https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00025095.

scholarly journals Cerebral oximetry and postoperative delirium after cardiac surgery: a randomised, controlled trial

Anaesthesia ◽  
2017 ◽  
Vol 72 (12) ◽  
pp. 1456-1466 ◽  
Author(s):  
L. Lei ◽  
R. Katznelson ◽  
L. Fedorko ◽  
J. Carroll ◽  
H. Poonawala ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Randomised Controlled Trial ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Cerebral Oximetry ◽  
Randomised Controlled

Cardiovascular Single-Unit Stay: A Case Study in Change

2004 ◽  
Vol 13 (5) ◽  
pp. 406-409 ◽  
Author(s):  
Elizabeth I. Clark ◽  
Constance L. Roberts ◽  
Karen C. Traylor
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Single Unit ◽  
Care Delivery ◽  
Medical Center ◽  
Postoperative Course ◽  
Lengths Of Stay ◽  
Care Delivery Model

A cardiovascular single-unit-stay program began at North Memorial Medical Center, Robbinsdale, Minn, in January 2000. Before then, cardiac surgery patients had been admitted to the intensive care unit directly from the operating room and then transferred to the postcoronary care unit on postoperative day 1 or 2. The traditional care delivery model created multiple transfers and delays in care, which often led to dissatisfaction among patients, increased costs, and greater potential for errors. The cardiovascular single-unit-stay program allows patients to stay in the same room with a consistent care team throughout the patients’ postoperative course. Decreased lengths of stay, decreased morbidity and mortality, increased satisfaction among patients and their families, and improved collaboration between members of the multidisciplinary team are just a few of the positive trends since the program’s inception.

scholarly journals The relationship between intraoperative cerebral oximetry and postoperative delirium in patients undergoing off-pump coronary artery bypass graft surgery: a retrospective study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Leerang Lim ◽  
Karam Nam ◽  
Seohee Lee ◽  
Youn Joung Cho ◽  
Chan-Woo Yeom ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Coronary Artery ◽  
Postoperative Delirium ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Cerebral Oximetry ◽  
Artery Bypass Graft ◽  
Off Pump ◽  
Pump Coronary Artery Bypass ◽  
The Relationship

Abstract Background Cerebral oximetry has been widely used to measure regional oxygen saturation in brain tissue, especially during cardiac surgery. Despite its popularity, there have been inconsistent results on the use of cerebral oximetry during cardiac surgery, and few studies have evaluated cerebral oximetry during off pump coronary artery bypass graft surgery (OPCAB). Methods To evaluate the relationship between intraoperative cerebral oximetry and postoperative delirium in patients who underwent OPCAB, we included 1439 patients who underwent OPCAB between October 2004 and December 2016 and among them, 815 patients with sufficient data on regional cerebral oxygen saturation (rSO2) were enrolled in this study. We retrospectively analyzed perioperative variables and the reduction in rSO2 below cut-off values of 75, 70, 65, 60, 55, 50, 45, 40, and 35%. Furthermore, we evaluated the relationship between the reduction in rSO2 and postoperative delirium. Results Delirium occurred in 105 of 815 patients. In both univariable and multivariable analyses, the duration of rSO2 reduction was significantly longer in patients with delirium at cut-offs of < 50 and 45% (for every 5 min, adjusted odds ratio (OR) 1.007 [95% Confidence interval (CI) 1.001 to 1.014] and adjusted OR 1.012 [1.003 to 1.021]; p = 0.024 and 0.011, respectively). The proportion of patients with a rSO2 reduction < 45% was significantly higher among those with delirium (adjusted OR 1.737[1.064 to 2.836], p = 0.027). Conclusions In patients undergoing OPCAB, intraoperative rSO2 reduction was associated with postoperative delirium. Duration of rSO2 less than 50% was 40% longer in the patients with postoperative delirium. The cut-off value of intraoperative rSO2 that associated with postoperative delirium was 50% for the total patient population and 55% for the patients younger than 68 years.

Postoperative Delirium is Associated with Postoperative Cognitive Dysfunction at One Week after Cardiac Surgery with Cardiopulmonary Bypass

2009 ◽  
Vol 105 (3) ◽  
pp. 921-932 ◽  
Author(s):  
Judith A. Hudetz ◽  
Alison J. Byrne ◽  
Kathleen M. Patterson ◽  
Paul S. Pagel ◽  
David C. Warltier
Keyword(s):  
Cardiac Surgery ◽  
Intensive Care ◽  
Cognitive Impairment ◽  
Cardiopulmonary Bypass ◽  
Cognitive Dysfunction ◽  
Postoperative Delirium ◽  
Postoperative Cognitive Dysfunction ◽  
Surgical Patients ◽  
Nonverbal Memory ◽  
Surgery Group

Postoperative delirium with cognitive impairment frequently occurs after cardiac surgery. It was hypothesized that delirium is associated with residual postoperative cognitive dysfunction in patients after surgery using cardiopulmonary bypass. Male cardiac surgical patients ( M age = 66 yr., SD = 8; M education = 13 yr., SD = 2) and nonsurgical controls ( M age = 62, SD = 7; M education = 12, SD = 2) 55 years of age or older were balanced on age and education. Delirium was assessed by the Intensive Care Delirium Screening Checklist preoperatively and for up to 5 days postoperatively. Recent verbal and nonverbal memory and executive functions were assessed (as scores on particular tests) before and 1 wk. after surgery. In 56 patients studied ( n = 28 Surgery; n=28 Nonsurgery), nine patients from the Surgery group developed delirium. In the Surgery group, the proportion of patients having postoperative cognitive dysfunction was significantly greater in those who experienced delirium (89%) compared with those who did not (37%). The odds of developing this dysfunction in patients with delirium were 14 times greater than those who did not. Postoperative delirium is associated with scores for residual postoperative cognitive dysfunction 1 wk. after cardiac surgery.

scholarly journals The use of dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium in cardiac surgery patients over 60 years of age: a pilot study

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1842 ◽  
Author(s):  
Ammu T. Susheela ◽  
Senthil Packiasabapathy ◽  
Doris-Vanessa Gasangwa ◽  
Melissa Patxot ◽  
Jason O’Neal ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Pilot Study ◽  
Study Protocol ◽  
Large Scale ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Total Incidence ◽  
Number Of Patients ◽  
Opioid Administration ◽  
Intravenous Acetaminophen

Background: Delirium is associated with many negative health outcomes. Postoperative sedation and opioid administration may contribute to delirium. We hypothesize that the use of dexmedetomidine and Intravenous acetaminophen (IVA) may lead to reduced opioid consumption and decreased incidence of postoperative delirium. This pilot study aims to assess feasibility of using dexmedetomidine and IVA in cardiac surgical patients, and obtain effect size estimates for incidence and duration of delirium. Methods: A total of 12 adult patients >60 years of age undergoing cardiac surgery were recruited for the study after IRB approval and randomized into 4 groups: Propofol only (P), Propofol with IVA (P+A), Dexmedetomidine only (D), Dexmedetomidine with IVA (D+A). Preoperative baseline cognition and postoperative delirium was assessed daily until discharge. The feasibility was assessed by the number of patients who successfully completed the study. Results: All patients completed the study protocol successfully. The total incidence of delirium in the study population was 42% (5/12):  67% (2/3) in the group P, and 67% (2/3) in the group D, 33% (1/3) in  D+A group and 0%(0/3)  P+A group. The incidence of delirium was 17% (1/6) in the group receiving IVA compared to 67% (4/6) that did not receive IVA. The mean duration of delirium was 0-1 days. One patient expired after surgery, unrelated to the study protocol. One patient in the D group experienced hypotension with systolic blood pressure <90 mm of Hg. Conclusions: The feasibility of performing a large-scale project is ascertained by the study. Patients receiving IVA had lower incidence of delirium compared to patients not receiving IVA which suggests that IVA may have a role in reducing the incidence of delirium. A prospective randomized, placebo-controlled trial will be the next step in investigating the role of dexmedetomidine and IVA in reducing the incidence of delirium.

scholarly journals Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032935
Author(s):  
Joanna S Semrau ◽  
Stephen H Scott ◽  
Andrew G Hamilton ◽  
Dimitri Petsikas ◽  
Darrin M Payne ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Neurological Outcome ◽  
Postoperative Delirium ◽  
Cerebral Oximetry ◽  
Elective Cardiac Surgery ◽  
Peer Review Journal ◽  
Registration Number ◽  
Oral Presentations

IntroductionPatients undergoing cardiac surgery may experience both short-term and long-term postoperative neurological problems. However, the underlying cause of this impairment is unclear. Regional cerebral oxygen saturation (rSO2) levels may play a role in the development of acute dysfunction, known as postoperative delirium, in addition to longer term outcomes after cardiac surgery. Yet the degree of impairment has been difficult to define, partly due to subjective methods of assessments. This study aims to fill this knowledge gap by determining the relationship between rSO2, postoperative delirium and long-term neurological outcome after cardiac surgery using quantitative robotic technology.Methods and analysis95 patients scheduled for elective cardiac surgery will be recruited for this single-centre prospective observational study. Patients will be assessed before as well as 3 and 12 months after their surgery using the Kinarm End-Point Lab and standardised tasks. Intraoperatively, rSO2 and other haemodynamic data will be collected for the duration of the procedure. Following their operation, patients will also be screened daily for delirium during their hospital stay.Ethics and disseminationThis study has been approved by the Health Sciences Research Ethics Board at Queen’s University (DMED-1672–14). The results of this study will be published in a peer-review journal and presented at international and/or national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication.Trial registration numberNCT04081649

Sign in / Sign up

Export Citation Format

Share Document