Clinical Research Directory

Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study

The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients

The current multicenter stepped wedge randomized cluster trial study aims to assess whether implementation of preoperative multidisciplinary team (MDT) discussions is (cost)effective for high risk noncardiac surgical patients. The main questions to answer are: * Primary question: Does implementation of preoperative multidisciplinary team discussions for high risk noncardiac surgical patients diminish serious adverse events as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment? * Secondary questions: Does implementation of preoperative multidisciplinary team discussion for high risk noncardiac surgical patients improve disability, survival, functional outcome, quality of life and cost-effectiveness as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment? Participants will be asked to answer questionnaires at baseline, 3, 6,9 and 12 months postoperatively or post MDT discussion. Patients for whom no structured preoperative multidisciplinary discussion is installed yet (care as usual) will be compared with patients for whom a structured preoperative multidisciplinary discussion is performed (intervention). The study will be performed in hospitals that have no established preoperative MDT meeting at the start of the study.

Effect of Podcast-Based Education on Preoperative Nursing Competency and Evidence-Based Knowledge in Nursing Students

This study aims to evaluate the effectiveness of podcast-based education on nursing students' competency in preoperative patient care and their knowledge of evidence-based nursing practices. Preoperative care is a critical component of perioperative nursing and plays a key role in patient safety and surgical outcomes. Improving students' competency in this area is essential for maintaining quality care. In this quasi-experimental controlled study, undergraduate nursing students will be randomly assigned to either a control group receiving standard classroom education or an intervention group receiving standard education supplemented with structured podcast materials focusing on preoperative patient preparation and assessment. Outcomes will be measured using validated competency and knowledge assessment tools administered before and four weeks after the educational intervention. The study is designed as a minimal-risk educational intervention and seeks to determine whether podcast-based learning can enhance competency and evidence-based knowledge in nursing education.

Preoperative Optimization Before Total Hip or Knee Replacement Surgery

Preoperative Optimisation prior to Hip and Knee Arthroplasty (PrOpE) Many patients scheduled for planned hip or knee replacement surgery have health conditions that may affect recovery, such as reduced physical fitness, nutritional problems, multiple medications, or increased stress and anxiety. These factors can increase the risk of complications and delay recovery after surgery. The PrOpE study examines whether a structured preparation programme before surgery, known as preoperative optimization or prehabilitation, can be safely implemented and may support recovery after hip or knee replacement. Aim of the study The main aim is to assess the feasibility of a comprehensive preoperative optimisation programme and to explore its potential effects on recovery and health outcomes. The results will help improve future care for patients undergoing major orthopaedic surgery. Who can participate? Adult patients scheduled for elective total hip or knee replacement surgery who are classified as ASA \>2, aged between 18 and 99 years old and without a severe cognitive impairment. Participation is voluntary. Study design A total of 180 participants will be included and randomly assigned to one of two groups: • Standard Care Group: Participants receive usual medical care before and after surgery. • Intervention Group: In addition to standard care, participants receive an individualised preparation programme over several weeks before surgery. This programme may include: * Personalised physical exercise * Nutritional assessment and advice * Support for stress, pain, and mental well-being * Review of regular medications Some elements may be delivered at home or via telemedicine, depending on individual needs. What information is collected? The study evaluates recovery after surgery, including complications, length of hospital stay, physical function, quality of life, and use of health care services. Questionnaires, physical tests, and blood samples are used to better understand health status before and after surgery. Risks and benefits The study involves low additional risk. All measures are adapted to individual abilities and supervised by trained professionals. The main burden is the additional time required for participation. Participants in the optimisation group may benefit from improved preparation for surgery. The study also contributes to improving care for future patients.

Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery

This study aims to verify the accuracy of blood pressure, heart rate, blood oxygen saturation, anxiety level, and sleep cycle data measurements obtained from Samsung smartwatches compared to the currently accepted method used in patients with disc herniation undergoing the preoperative period.

Prospective Validation of an Artificial Intelligence Tool for Pre-Anesthetic Assessment

This prospective observational cohort study aims to validate an artificial intelligence (AI) tool designed for pre-anesthetic assessment in Portuguese, tailored to the Brazilian healthcare context. Conducted at a single tertiary hospital, the study will enroll 270 adult patients (aged \>18 years) scheduled for elective non-cardiac surgeries. Participants will use the AI tool to complete a self-assessment, generating general patient guidance and a detailed medical evaluation (the latter withheld from the anesthesiologist). A standard pre-anesthetic evaluation will then be performed by an anesthesiologist blinded to the AI results. A third blinded anesthesiologist will compare the assessments for accuracy, consistency, and risk identification (e.g., ASA classification and perioperative risk models). Primary outcome is concordance between AI and human assessments using Cohen's Kappa. Secondary outcomes include anesthesiologist perceptions of the tool's utility, impact on assessment quality, and patient usability challenges. The study poses minimal risks, with data collected over 24 months, and aims to enhance perioperative safety and efficiency in Brazil.

Carbohydrate Ingestion Prior to Surgery (CIPS)

The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, surgical outcomes and patient health. Patients will be randomized to receive a specialized sports drink or a standard sports drink. Patients will have a continuous glucose monitor (CGM) placed on their upper arm to measure glucose throughout surgery and during the post-operative period.

TELENURSING IN THE IMMEDIATE PREOPERATIVE PERIOD OF ELECTIVE SURGERIES

Introduction: Telenursing encompasses Nursing Consultation, Interconsultation, Consulting, Monitoring, Health Education and Reception of Spontaneous Demand mediated by Information and Communication Technology. Objective: To perform a cost-effectiveness analysis of telenursing in the immediate preoperative period of adult patients undergoing elective surgeries in a university hospital of the SUS. Materials and method: Cost-effectiveness analysis nested in a clinical trial or empirical economic analysis of the piggyback evaluation type. Divided into 2 phases: a) Experimental research - randomized clinical trial to be carried out in a university hospital located in Rio de Janeiro and part of the SUS, with two parallel groups - intervention and control - with 1:1 allocation. The inclusion criteria will be adult patients, of both sexes, in the immediate preoperative period who are admitted on the day of elective surgery from their home. Patients who are hospitalized, patients in ophthalmology and obstetrics specialties, and those who will undergo examinations in the surgical center will be excluded. The sample size calculation was performed with a 95% confidence level and a sample loss of 5%, totaling 352 patients. The sampling will be random. Randomization and allocation concealment will be performed by the independent researcher. Patients in the GI will receive telenursing on the day before surgery with an anamnesis script for telenursing by the main researcher. On the day of surgery, all patients on the surgical map who came from their residence will be directed to the nursing assessment room where the auxiliary researcher will apply the in-person anamnesis script. The data will be processed by two independent researchers in an electronic spreadsheet and will be analyzed using descriptive and inferential statistics. The research will respect all legal and ethical frameworks necessary for its implementation; b) Prospective analysis of complete economic evaluation - in the piggyback evaluation modality - of the cost-effectiveness type. The effectiveness of telenursing will be verified by the outcome of surgical cancellation. A decision tree model will be used with a view to analyzing the SUS user at the local level (microcosting). The time horizon will be two days. The cost-effectiveness threshold will be 1 GDP per capita and the data analysis will include deterministic and probabilistic sensitivity. Expected results: It is expected to prove that telenursing can be a safe and efficient method for guiding patients before surgery, generating greater patient satisfaction, increasing access to information about health care for users through remote communication with nurses, reducing the waiting list by reducing surgical cancellations and possible incorporation of telenursing as a consolidated practice in the university hospital studied.

The Risk of Surgical Cancellation in Adult Patients Assessed by Telephone Versus In-person for Scheduled Non-cardiac Elective Surgery.

Telemedicine has been regulated in Colombia since 2006, with applications in anesthesia being explored since 2004 to improve accessibility and reduce costs. Although Decree 538 of 2020 expanded telemedicine's medical applications, challenges such as connectivity issues and the need for training remain. Telemedicine has shown promise in rural areas of Colombia, particularly for managing chronic diseases. However, further evidence is needed regarding the effectiveness of telephone pre-anesthetic evaluations. This study aims to investigate the implementation of telephone assessments for non-cardiac surgery and their impact on surgical cancellations compared to in-person pre-anesthetic evaluations. The primary question we seek to answer is: Does telephone pre-anesthetic assessment in non-cardiac surgical patients carry a higher risk of surgical cancellations compared to in-person evaluations? To address this question, we will evaluate patients' medical records in two hospitals where patients were assessed using both telephone and in-person modalities.

Integrating ChatGPT in Anesthesia

Patients are waiting for surgery longer than ever before. While hospitals are trying to get patients access to surgery as quickly as possible, a shortage of anesthesia doctors (called anesthesiologists) prevents this. Every surgery needs an anesthesiologist, but anesthesiologists also assess patients beforehand to ensure they can safely undergo surgery and help patients understand what to expect and the risks involved. Ensuring that patients move through surgery as safely and efficiently as possible requires that the limited number of anesthesiologists in Canada work as efficiently as possible. Technology like Artificial Intelligence (AI), in programs such as ChatGPT, might assist by answering common questions patients have, allowing anesthesiologists to focus their limited time on addressing complex and personalized issues for each patient. However, studies conducted so far on how well AI can answer questions about anesthesia and surgery have been poorly designed and have not included patients as members of the research team. This study will determine whether AI can answer patients' questions before surgery as effectively as both patients and expert anesthesiologists would expect, which could be beneficial to patients and the healthcare system.

Prehab for Surgery

Surgical prehabilitation is the process of enhancing one's physical function and mental capacity to enable him/or her to withstand the stressor of surgery. Prehabilitation can be achieved via optimizing physical fitness, nutrition, and psychological health. Studies have shown that prehabilitation may prevent complications during and after surgery, reduce hospital length of stay, and improve postoperative recovery. Despite the growing interest in the field of prehabilitation, little is understood about how to implement prehabilitation an integrated clinical service. This study will examine the effect of a prehabilitation program that includes exercise, psychological, and nutritional optimization that emulates clinical integration pathways. Participants of this study will have a choice of participating in facility-based prehabilitation (FBP) or home-based prehabilitation (HBP) depending on their needs/accessibility to the Toronto General Hospital. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 and 90 days postoperatively. A comprehensive assessment of feasibility will also be conducted to better understand facilitators and barriers to clinical integration.