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Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.

ABSTRACT: INTRODUCTION:Postoperative delirium, arbitrarily defined as occurring within 5?days of surgery, affects up to 50% of patients older than 60 after a major operation. This geriatric syndrome is associated with longer intensive care unit and hospital stay, readmission, persistent cognitive deterioration and mortality. No effective preventive methods have been identified, but preliminary evidence suggests that EEG monitoring during general anaesthesia, by facilitating reduced anaesthetic exposure and EEG suppression, might decrease incident postoperative delirium. This study hypothesises that EEG-guidance of anaesthetic administration prevents postoperative delirium and downstream sequelae, including falls and decreased quality of life. METHODS AND ANALYSIS:This is a 1232 patient, block-randomised, double-blinded, comparative effectiveness trial. Patients older than 60, undergoing volatile agent-based general anaesthesia for major surgery, are eligible. Patients are randomised to 1 of 2 anaesthetic approaches. One group receives general anaesthesia with clinicians blinded to EEG monitoring. The other group receives EEG-guidance of anaesthetic agent administration. The outcomes of postoperative delirium (?5?days), falls at 1 and 12 months and health-related quality of life at 1 and 12 months will be compared between groups. Postoperative delirium is assessed with the confusion assessment method, falls with ProFaNE consensus questions and quality of life with the Veteran's RAND 12-item Health Survey. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 95% CIs and will be considered statistically significant at a two-sided p<0.05. ETHICS AND DISSEMINATION:Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) is approved by the ethics board at Washington University. Recruitment began in January 2015. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media. TRIAL REGISTRATION NUMBER:NCT02241655; Pre-results.

SUBMITTER: Wildes TS

PROVIDER: S-EPMC4916634 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.

Wildes T S TS Winter A C AC Maybrier H R HR Mickle A M AM Lenze E J EJ Stark S S Lin N N Inouye S K SK Schmitt E M EM McKinnon S L SL Muench M R MR Murphy M R MR Upadhyayula R T RT Fritz B A BA Escallier K E KE Apakama G P GP Emmert D A DA Graetz T J TJ Stevens T W TW Palanca B J BJ Hueneke R R Melby S S Torres B B Leung J M JM Jacobsohn E E Avidan M S MS

BMJ open 20160615 6

<h4>Introduction</h4>Postoperative delirium, arbitrarily defined as occurring within 5 days of surgery, affects up to 50% of patients older than 60 after a major operation. This geriatric syndrome is associated with longer intensive care unit and hospital stay, readmission, persistent cognitive deterioration and mortality. No effective preventive methods have been identified, but preliminary evidence suggests that EEG monitoring during general anaesthesia, by facilitating reduced anaesthetic exp ...[more]

PMID: 27311914

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Project description:Background: There is some evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium after non-cardiac surgery. There is limited evidence in this regard for cardiac surgery. A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death. However, it is not yet clear whether this electroencephalographic pattern reflects an underlying vulnerability associated with increased incidence of delirium and mortality, or whether it is a modifiable risk factor for these adverse outcomes. Methods: The Electroe ncephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes ( ENGAGES-Canada) is an ongoing pragmatic 1200 patient trial at four Canadian sites. The study compares the effect of two anesthetic management approaches on the incidence of POD after cardiac surgery. One approach is based on current standard anesthetic practice and the other on electroencephalography guidance to reduce POD. In the guided arm, clinicians are encouraged to decrease anesthetic administration, primarily if there is electroencephalogram suppression and secondarily if the EEG index is lower than the manufacturers recommended value (bispectral index (BIS) or WAVcns below 40 or Patient State Index below 25). The aim in the guided group is to administer the minimum concentration of anesthetic considered safe for individual patients. The primary outcome of the study is the incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review. Secondary outcomes include unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation. Discussion: The ENGAGES-Canada trial will help to clarify whether or not using the electroencephalogram to guide anesthetic administration during cardiac surgery decreases the incidence, severity, and duration of POD. Registration: ClinicalTrials.gov ( NCT02692300) 26/02/2016.

Project description:BackgroundApproximately 40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older. Standard treatment for advanced disease consists of cytoreductive surgery and combination chemotherapy. In older patients, standard treatment is often withheld or prematurely stopped due to suspected frailty. It remains challenging to distinguish fit elderly patients who can endure standard therapy from frail patients who may benefit from an adapted treatment strategy. As a comprehensive geriatric assessment (CGA) can contribute to the identification of frail patients and improve tailored therapy in this population, screening tests were developed to select those who may benefit from a CGA. However, the use of these geriatric screening tests has rarely been compared with usual clinical care. The GERSOC-trial will evaluate whether geriatric screening in elderly patients with advanced-stage ovarian cancer improves treatment completion and quality of life.MethodsThis pragmatic, cluster randomised controlled trial will be conducted at a minimum of 20 hospitals in the Netherlands. Hospitals are randomly assigned to geriatric screening care (in which a geriatric screening comprised of the G8 questionnaire and the Timed Up and Go test is performed), or care as usual (in which current usual care is continued). A total of 320 patients aged ≥ 70 years with primary, advanced-stage ovarian carcinoma will be included. Patients considered fit on geriatric screening will receive standard treatment; patients who are considered unfit will be referred to a geriatrician for analysis and treatment advice. The primary outcome is the percentage difference in completed standard and adapted therapies between the two study arms. Secondary outcomes include quality of life, cost-effectiveness and survival.DiscussionThis trial aims to gather evidence for the use of geriatric screening in treatment decision-making in elderly patients with advanced ovarian cancer. If proven feasible, beneficial and cost-effective, geriatric screening may be implemented in routine clinical practice.Trial registrationNetherlands Trial Registry, ID: NL6745. Registered on 2 August 2017.

Project description:IntroductionPersonal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation.Methods and analysisWe are conducting a prospective, open-label multicentre pragmatic randomised clinical trial, leveraging a unique patient-centred health data sharing platform for enrolment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation or atrial flutter will be randomised 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion. Secondary outcomes include inpatient and outpatient healthcare utilisation. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings.Ethics and disseminationThe Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians and patients about the impact of the heart rate, irregular rhythm notification, and ECG features of widely used personal digital devices on patient quality of life and healthcare utilisation. Findings will be disseminated to study participants, at professional society meetings and in peer-reviewed journals.Trial registration numberNCT04468321.

Project description:IntroductionOlder patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs.Methods and analysisThe Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders.Ethics and disseminationThe protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care.Trial registration numberNCT02664454; Pre-results.

Project description:IntroductionThe majority of aged long-term care receivers and patients in geriatric acute care are affected by some form of incontinence. These individuals are at risk of developing incontinence-associated dermatitis (IAD), a common type of irritant contact dermatitis caused by repeated and prolonged direct contact of the skin with urine and stool. The prevalence of IAD in these settings is high. Preventive measures include mild skin cleansing and the application of skin protecting leave-on products. Available evidence is weak regarding the comparative performance of different skin protection strategies and products due to a lack of confirmatory trials using relevant comparators and endpoints. Therefore, the overall aim of this exploratory trial is to compare the effects of three skin protection strategies to estimate effect sizes of the recently published core outcomes in IAD research.Methods and analysisA pragmatic three-arm, assessor-blinded, randomised controlled, exploratory trial with parallel group design will be performed, comparing film-forming and lipophilic skin protecting leave-on products for IAD prevention with standard incontinence care alone. The trial will be conducted in geriatric nursing homes and geriatric acute care settings in the federal state of Berlin, Germany. A total of n=210 participants being incontinent of urine and stool will be included. Outcomes include IAD incidence, erythema, erosion, maceration, IAD-related pain, patient satisfaction, safety, feasibility and compliance. IAD incidence of the control and intervention groups will be compared to estimate effect sizes, and the procedural feasibility of the intervention will be tested to plan a possible subsequent confirmatory randomised controlled trial.Ethics and disseminationThe study received the approval of the ethics committee of Charité-Universitätsmedizin Berlin (EA4/043/22). Results will be disseminated through peer-reviewed open-access journals and international conferences.Trial registration numberClinicalTrials.gov (NCT05403762) and German Clinical Trials Register (Deutsches Register Klinischer Studien, or DRKS) (DRKS00028954).

Project description:IntroductionThe number of elderly patients undergoing major surgery is rapidly increasing. They are particularly at risk of developing postoperative neurocognitive disorders (NCD). Earlier studies suggested that processed electroencephalographic (EEG) monitors may reduce the incidence of postoperative NCD. However, none of these studies controlled for intraoperative nociception levels or personalized blood pressure targets. Their results remain unclear if the reduction in the incidence of postoperative NCD relates to avoidance of any electroencephalographic pattern suggesting excessive anesthesia depth.ObjectiveThe objective of this trial is to investigate-in patients ≥ 70 years old undergoing major non-cardiac surgery-the effect of EEG-guided anesthesia on postoperative NCD while controlling for intraoperative nociception, personalized blood pressure targets, and using detailed information provided by the EEG monitor (including burst suppression ratio, density spectral array, and raw EEG waveform).Material and methodsThis prospective, randomized, controlled trial will be conducted in a single Canadian university hospital. Patients ≥ 70 years old undergoing elective major non-cardiac surgery will be included in the trial. The administration of sevoflurane will be adjusted to maintain a BIS index value between 40 and 60, to keep a Suppression Ratio (SR) at 0%, to keep a direct EEG display without any suppression time and a spectrogram with most of the EEG wave frequency within the alpha, theta, and delta frequencies in the EEG-guided group. In the control group, sevoflurane will be administered to achieve an age-adjusted minimum alveolar concentration of [0.8-1.2]. In both groups, a nociception monitor will guide intraoperative opioid administration, individual blood pressure targets will be used, and cerebral oximetry used to tailor intraoperative hemodynamic management. The primary endpoint will be the incidence of NCD at postoperative day 1, as evaluated by the Montreal Cognitive Assessment (MoCA). Secondary endpoints will include the incidence of postoperative NCD at different time points and the evaluation of cognitive trajectories up to 90 days after surgery among EEG-guided and control groups.Study registrationNCT04825847 on ClinicalTrials.gov.

Project description:Introduction:Chronic migraine is a largely refractory condition affecting between 1 and 2.2% of the overall population worldwide, with females more affected than males. There are also high health and socioeconomic costs associated both for the individual and society. The mainstay of chronic migraine management is pharmacological, but the options available have limited efficacy and there are often unwanted side effects. There is some evidence for manual therapy as a treatment option for migraine, but its effectiveness for chronic migraine is unknown. Therefore, we have designed a pragmatic randomised control trial to investigate whether adding manual therapy to the tertiary specialist treatment of chronic migraine improves patient-reported outcomes. Methods:A pragmatic, randomised controlled trial in a hospital tertiary headache clinic. Participants will be randomised into one of two groups: treatment as usual or treatment as usual plus manual therapy. The primary outcome measure will be a change in the Headache Impact Test score. Secondary outcomes will also be measured over the 12-week study period including changes in headache frequency, migraine specific quality of life and reductions in relevant medicine consumption. The manual therapy group will have five treatment sessions each lasting 30?min. The recruitment target of 64 participants will allow power at 80% with p?=?0.05 using minimal clinical difference for Headache Impact Test of 3.7 and includes provision for a 10% dropout rate. Recruitment will take place between August 2018 and February 2019. The results will form part of a doctoral study and be published in peer-reviewed journals and presented at national/international conferences. Discussion:Current pharmacological approaches have limited effects in the management of chronic migraine and there is a requirement to improve treatment options and reduce the health and economic burden of the condition. Manual therapy has been shown to be effective in other chronic pain conditions as well as other primary headaches. This study will explore the effectiveness of manual therapy as an adjunctive approach to the management of chronic migraine. Trial registration:The trial has received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.

Dataset Information

Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.

Publications

Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.

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