Clinical Research Directory

Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment

Intraoperative hypotension, defined as a drop in blood pressure during surgery, is a frequent event in patients undergoing general anesthesia. Even brief episodes of low blood pressure may reduce blood flow to vital organs such as the brain, heart, and kidneys, and have been associated with an increased risk of postoperative complications, prolonged recovery, and worse clinical outcomes. Despite its clinical importance, the management of intraoperative hypotension is often based on general guidelines and individual clinician experience rather than patient-specific physiological mechanisms. Low blood pressure during surgery can occur for different underlying reasons, including reduced circulating blood volume, excessive vasodilation caused by anesthetic agents, impaired heart contractility, or abnormalities in heart rate. In routine practice, these mechanisms are not always clearly distinguished, and similar treatment strategies may be applied to patients with different physiological causes of hypotension. As a result, the response to treatment can vary widely between patients. This prospective observational study aims to improve the understanding of intraoperative hypotension by collecting detailed hemodynamic data during surgery and analyzing these data using machine learning methods. The study is designed to observe current clinical practice without altering or interfering with routine patient care. All decisions regarding anesthesia management and treatment of hypotension will be made by the attending anesthesiologists according to standard clinical practice. The research team will not provide treatment recommendations during surgery. Adult patients undergoing elective surgery under general anesthesia with continuous invasive arterial blood pressure monitoring will be included. During the intraoperative period, blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance, and other advanced hemodynamic parameters will be continuously recorded at regular intervals. When hypotension occurs, the onset, duration, and severity of the episode will be documented, along with the treatment applied, such as fluid administration, vasopressor agents, or inotropic medications. The time required for blood pressure to recover to an acceptable level will also be recorded. The collected data will be analyzed using machine learning techniques to identify distinct subtypes of intraoperative hypotension based on physiological patterns. These subtypes may reflect different underlying mechanisms, such as hypovolemia, vasodilation, myocardial depression, or heart rate-related causes. In addition, the study will evaluate how different treatment strategies perform across these hypotension subtypes and how quickly hemodynamic stability is restored. Patient-related factors such as age, sex, body mass index, physical status classification, and comorbid conditions will also be examined to determine their relationship with the occurrence, severity, and treatment response of hypotension episodes. By combining patient characteristics, physiological data, and treatment responses, the study aims to generate data-driven insights into personalized hypotension management. The ultimate goal of this research is to support the development of individualized treatment recommendations for intraoperative hypotension based on objective physiological data rather than a one-size-fits-all approach. The findings of this study are expected to provide a strong scientific foundation for future clinical decision-support systems that can assist anesthesiologists in selecting the most appropriate treatment strategy for each patient. By improving the precision of blood pressure management during surgery, this approach has the potential to enhance patient safety and perioperative outcomes while maintaining standard clinical workflows.

Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study

The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care. The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need. The research team's goals are to: * Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials. * Determine if the intervention improves meeting presurgical criteria for vaginoplasty. * Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable. The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice. The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 290 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators trained in collaboration with Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course. The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly. In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.

Paired Comparison of SVV and PVI Accuracy

This study will compare two operating-room monitors-stroke volume variation (SVV, from the arterial line) and the Pleth Variability Index (PVI, from the pulse oximeter)-to see which one more accurately predicts whether giving a small fluid bolus will improve the heart's pumping during laparoscopic major abdominal surgery. Adults having elective surgery under general anesthesia will receive two small, timed 250-mL crystalloid infusions as part of routine care (one before and one after creation of the pneumoperitoneum). The research team will record SVV and PVI values just before and three minutes after each infusion while keeping these readings hidden from the clinicians so that usual care is not changed. No experimental drugs or devices are used. The main goal is to learn which index better identifies "fluid responsiveness," so future care can be safer and more consistent. Potential risks are minimal and relate to the small fluid boluses (temporary changes in blood pressure or heart rate); the test stops if the anesthesiologist has any safety concerns. There is no direct benefit to participants, but results may help guide fluid therapy for similar patients in the future. The study is being conducted at a single academic hospital in the Republic of Korea and plans to enroll about 300 adults.

Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.

Comparing CCI and POSSUM for Predicting Oncogynecologic Surgery Complications

With the global rates of gynecologic cancers on the rise, optimizing perioperative care is imperative. Accurate risk prediction is essential for enhancing patient care, directing preoperative interventions, and facilitating informed decision-making in oncology. This research compares two widely-used risk assessment tools: the Charlson Comorbidity Index (CCI) and the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM), in predicting perioperative outcomes. The CCI predominantly addresses comorbidities, providing simplicity and broad applicability, while POSSUM incorporates both physiological and operative factors for a more comprehensive risk assessment. Despite their application across various surgical specialties, the specific utility of these tools in onco-gynecologic surgery remains insufficiently explored. The study aims to evaluate the effectiveness of CCI and POSSUM in predicting perioperative complications, with a focus on the incidence of these complications, length of hospital stay, and 30-day mortality. The implementation of these risk tools may enhance multidisciplinary risk management, thus improving patient outcomes in gynecologic oncology surgery.

Fissios© and Postoperative Complications (FPoC Trial)

Respiratory physiotherapy as part of a pre-operative physical training program may reduce the risk of developing post-operative complications, improving post-operative results and optimizing physical conditions in patients with a diagnosis of non-small cell lung cancer (NSCLC) undergoing lung resection surgery. During the post-operative period, performing physical exercise has also been proved to increase the capacity for exercise, improve health-related quality of life and reduce the feeling of breathlessness. Fissios App is a tool created by thoracic surgeons, physiotherapists and a specialist doctor in physical medicine and rehabilitation, which has been satisfactorily implemented in thoracic surgery patients; this contains a program of standardized respiratory physiotherapy exercises with a defined time and number of repetitions. The aim is to compare the effectiveness of use of the Fissios App tool as a complement to a peri-operative respiratory physiotherapy program compared to just attendance at a face-to-face peri-operative respiratory physiotherapy program, to reduce the incidence of post-operative complications. It is expected to include 560 patients in the study. Subsequent to evaluation by the investigator and the acceptance of participant to take part in the study, the performing of peri-operative respiratory physiotherapy is prescribed. The participants will be randomly assigned to a study group that uses the tool as a complement to the respiratory physiotherapy program or a control group that should only attend face-to-face respiratory physiotherapy sessions. All the participants should attend face-to-face respiratory physiotherapy classes taught by physiotherapists at the place and time set out in each centre before and after surgery for at least 45 minutes and at least five sessions. Moreover, study group participants may use the Fissios App tool. Investigators should fill in the pre-operative, surgery and post-operative data for each patient on the Fissios Research platform.

Oral vs IV Sedation for Cataract Surgery in Older Adults

The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.

Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy

The purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic antithrombotic therapy before surgery.

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.

Patient's Database: Prepare for Your Surgery Program

Frailty is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors. These factors culminate in worse postoperative outcomes, including higher rates of complications and mortality. With the current demographic shift towards an aging population in Latin America and Chile, the prevalence of frailty among surgical patients is increasing. Despite the clear association between frailty and adverse postoperative effects, in Chile there are few centers that routinely perform objective preoperative frailty assessment before to surgery. This is due to logistical challenges, the need for specialized training, and assessment tools. As a result, frailty remains an underestimated syndrome in the perioperative setting. Various interventions have been proposed to improve the care of fragile surgical patients. Prehabilitation, a multidisciplinary program designed to prepare patients for surgery and improve their resilience to surgical stress, has emerged as a promising intervention. Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications. Recognizing the vital role that frailty plays in surgical outcomes and the paucity of research on prehabilitation, a prehabilitation or timely presurgical conditioning program (Prepare for Your Surgery Program) has been implemented at our center. This proposal seeks to optimize the patient before a surgical intervention in order to reduce frailty and complications, thus improving recovery and medium-term results. The program consists of interventions 4 to 6 weeks before surgery focused on: nursing assessment, screening and follow-up, geriatric and/or internal medicine assessment and intervention, physiotherapy assessment and intervention, nutrition assessment and intervention, psychological assessment and intervention, and preoperative anesthesiology intervention. For this purpose, it has been proposed to create a prospective database of patients from the Prepare for Your Surgery Program, who undergo elective surgery at Hospital Clinico Red Salud UC-Christus.

ImPortance of Arterial Measurement Sites (IPAMS) on Intraoperative Hemodynamic Management

The goal of this clinical trial is to demonstrate the importance of arterial pressure measurement sites during major abdominal surgeries. This randomized controlled trial will compare arterial pressure measurements obtained from radial artery catheterization (the current standard method of monitoring) with those obtained from brachial artery catheterization (a more accurate reflection of central arterial pressure). At the end of the study, we are looking to answer the following questions: 1. Does arterial pressure measurement sites influence the amount of vasopressors that is administered during major abdominal surgeries? 2. What are the instances where there is a difference between peripheral (radial catheter) and central (brachial catheter) monitoring and what are the risk factors leading to the appearance of this radial-brachial pressure gradient? 3. With the data collected, can artificial intelligence based analysis help predict the reliability of a radial monitoring and help guide clinicians on choosing a peripheral versus central arterial pressure monitoring site? All adult participants who are scheduled for elective major abdominal surgeries and meeting our inclusion criteria will be approached and included if they consent. Participants will be randomized 1:1 in the intervention group and the standard of care group. In the intervention group, the brachial arterial line will be used intraoperatively to guide vasopressor and fluid administration. A radial line will also be installed to measure the radial arterial pressure simultaneously, but will not be used to guide hemodynamic management. In the standard of care group, both lines will be installed just like in the intervention group, however, it is the radial arterial line that will guide fluid and vasopressor administration. In both groups, the anesthesia protocol will be standardized and the anesthesiologist will be blinded to the arterial pressure measurement site.

Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

Introduction Breast cancer remains a leading global health concern, with significant psychological challenges during the perioperative period. Traditional patient education focuses on disease management but often neglects emotional and cognitive needs. Perioperative inpatients are relatively stable and have the time and mental space for deeper education and psychological support. This study evaluates the clinical significance of a medical humanities-based education strategy for breast cancer patients during hospitalization, aiming to enhance psychological resilience, treatment adherence, and quality of life. Methods and Analysis This prospective, non-randomized, open-label study will include female patients with early-stage breast cancer scheduled for surgery at Fudan University Shanghai Cancer Center. Participants will be allocated to two cohorts: practical education group and mental enhanced group. The primary endpoint is psychological assessment at hospital discharge, including anxiety (GAD-7), depression (PHQ-9), and sleep quality (ISI). Secondary endpoints include the proportion of patients opting for breast-conserving procedures, incidence of postoperative complications, long-term treatment adherence (MMAS-8), patients' disease-coping resilience (CD-RISC-10), and quality of life assessment (EORTC QLQ instruments) at 12-month follow-up. Data collection and statistical analysis will be conducted using validated instruments and software, with significance set at p ≤0.05. Ethics and Dissemination Approved by the FUSCC ethics committee, all participants provide informed consent. Results will be disseminated through international conferences and peer-reviewed journals. The study adheres to ethical guidelines, ensuring data confidentiality via encrypted platforms. Authors declare no conflicts of interest, supported by Shanghai Municipal Science and Technology Innovation Action Plan (24DZ2303500). Findings aim to optimize perioperative education strategies, addressing psychological and informational needs of breast cancer patients.

Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation

The purpose of this study is to evaluate the impact of perioperative aspirin continuation on clinical outcomes in patients with a history of coronary stent implantation who are scheduled for abdominal surgery.

Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management

This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.

Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.