Clinical Research Directory

Diastolic Performance and Norepinephrine in Spinal-Induced Hypotension for Cesarean Delivery

Background and rationale: The best agent to prevent spinal-induced hypotension is still uncertain but norepinephrine showed fewer effects on heart rate and cardiac output. In septic patients norepinephrine has been shown to produce an "endogenous fluid challenge". Objective: We aim to assess if patients with impaired diastolic function (46% of pregnant women at term) are less able to maintain indexed cardiac output in response to norepinephrine infusion during spinal-induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery. Methods: We will assess by echocardiogram the diastolic function before surgery and will then start continuous non-invasive hemodynamic monitoring with a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) and perform a fluid challenge to relate diastolic disfunction with fluid responsiveness. Hemodynamic monitoring will continue throughout the surgery. Norepinephrine infusion will start concomitantly to beginning of spinal anesthesia and will stop 5 minutes after uterotonic medication. Outcome: We aim to assess if patients with diastolic disfunction are less able to maintain cardiac output in response to norepinephrine infusion during spinal anesthesia induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.)

Cardiac Arrest - Ultrasound Detection of Occult Perfusion

The goal of this study is to describe the population of patients presenting after out of hospital cardiac arrest with occult perfusion, defined as a patient without a palpable pulse but with some evidence of pulsatile arterial flow. The main questions it aims to answer are: * To measure the prevalence of patients of patients presenting to the emergency department after out of hospital cardiac arrest with occult perfusion * To measure the association between occult perfusion and survival * Compare survival between patients with occult perfusion that were treated as pulseless by ACLS interventions vs those treated as hypotensive Researchers will describe the percentage of out-of-hospital cardiac arrest presenting to the emergency department without a pulse but with occult perfusion. Researchers will also compare survival endpoints (ROSC, Survival to hospital Admission, and Survival to Hospital Discharge) in pulseless patients with occult perfusion treated with ACLS interventions only and pulseless patients with occult perfusion treated as if they had pulsatile arterial flow. Participants will undergo resuscitation based on decisions by the clinical team who incorporate echo and/or vascular ultrasound during the first three rounds of CPR. The resuscitation will continue until the patient demonstrates return of spontaneous circulation or until the clinical team halts resuscitative efforts due to futility.

Effects of Transitional Circulation in ELBW Infants

Prematurity is a very important problem in this country. Prematurity can cause problems with organ (such as the brain, heart, kidneys) growth and development. A very important part of keeping premature babies healthy is ensuring good blood flow to all of these organs. Some premature babies have problems with their hearts and getting enough blood out to the rest of their bodies. This problem is referred to as hypotension (low blood pressure) and is found by looking at blood test values and while examining the baby. These babies will need medications to help their heart deliver blood to all of the important areas in their bodies. Babies who have hypotension requiring medications tend to have more problems than premature babies that don't need hypotension medication. Some of these problems include a higher risk of bleeding into their brain, kidney problems, liver problems, intestinal (gut) problems causing difficulty tolerating feeds, and a very dangerous infection of their intestines. Some long term effects include hearing loss, developmental delay, and learning problems in the future that are worse than other premature babies who did not have hypotension. Hypotensive premature babies also have a higher risk of death. The cause of hypotension in the first week of life is still not known. We know that babies have to get used to being in the outside world instead of in the womb. A lot of changes with the heart and lungs have to happen for them to not be affected by that transition. If we could gain a better understanding of those changes, we might be able to prevent some of these issues from happening. This study will look closely at premature babies with and without hypotension to assess the heart and lung changes in the first week of life. To do this, we will use monitoring machines and tests to get a better idea of all the changes that happen. This information will help all neonatologists who care for premature babies.

Haemodynamic Effects of Four Sevoflurane Wash-In Strategies After Tracheal Intubation

The goal of this clinical trial is to compare how four different ways of starting sevoflurane anaesthesia (the "wash-in" phase) affect the heart and circulation during the first 10 minutes after endotracheal intubation in adults undergoing elective major urological surgery. The main question it aims to answer is whether the wash-in strategy affects cardiac index 10 minutes after intubation. Researchers also compared other haemodynamic variables, the time needed to reach the target anaesthetic concentration (0.8 MAC), sevoflurane consumption, the need for ephedrine to treat low blood pressure, and depth of anaesthesia. After a standard intravenous induction, participants were randomly assigned to one of four sevoflurane wash-in strategies: automated end-tidal-controlled delivery, or manual delivery with 0.5 L/min fresh gas flow and 8% sevoflurane, 1 L/min with 4% sevoflurane, or 2 L/min with 4% sevoflurane. Haemodynamic variables were measured continuously through a radial arterial line using the pressure recording analytical method (PRAM).

Prophylactic Ondansetron for Preventing Spinal Anesthesia-Induced Hypotension in Elective Cesarean Section

Spinal anesthesia is the preferred technique for elective cesarean section, but it frequently causes maternal hypotension due to sympathetic blockade and the Bezold-Jarisch reflex, which can threaten both mother and baby. Ondansetron, a serotonin 5-HT3 receptor antagonist commonly used to prevent nausea and vomiting, may attenuate this reflex. The purpose of this prospective, randomized, controlled, single-blind study is to evaluate whether a single prophylactic intravenous dose of ondansetron (4 mg) given before spinal anesthesia reduces the incidence of hypotension in women undergoing elective cesarean section. Vasopressor (ephedrine) requirement, heart rate, postspinal shivering, intraoperative nausea and vomiting, and newborn Apgar scores are also compared between the ondansetron and control (saline) groups.

Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery

This prospective observational cohort study investigates whether pre-anesthetic pupillary light reflex (PLR) parameters can predict the risk of hypotension following spinal anesthesia in women undergoing elective cesarean section. Spinal anesthesia-induced hypotension is common, with reported incidence rates of 50-90%, and current predictors such as baseline blood pressure and BMI have limited accuracy. PLR, a sensitive marker of autonomic nervous system balance, may offer a simple, objective, and non-invasive tool for identifying patients at higher risk. The study evaluates pupillary reaction latency and other PLR parameters and correlates them with post-spinal blood pressure changes to determine their predictive value.

Pre-induction Norepinephrine in Septic Patients Undergoing Surgery

This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia.

Oliceridine Versus Sufentanil for Blood Pressure Control During Anesthesia Induction in Older Women With Hypertension Undergoing Gynecological Laparoscopic Surgery

Blood pressure can fall during the start of general anesthesia, particularly in older patients with high blood pressure. This study compared two medicines, oliceridine and sufentanil, to assess their effects on low blood pressure during anesthesia induction in older women with hypertension undergoing gynecological laparoscopic surgery. This single-center randomized controlled trial enrolled 134 women aged 65 to 80 years at the Affiliated Hospital of Nantong University. Participants were assigned to receive either oliceridine or sufentanil, together with the same other anesthesia induction medicines. Blood pressure and heart rate were measured before induction, one minute after induction, immediately after insertion of the breathing tube, and one and five minutes after insertion. The main outcome was the proportion of participants who experienced low blood pressure during these measurements. Low blood pressure was defined as a mean arterial pressure below 65 mmHg or a decrease of at least 30% from the value measured before induction. Other assessments included changes and variability in blood pressure, heart rate, and the use of medicines to support blood pressure.

Granisetron Use, Blood Pressure, and Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia

This study will observe 80 adults having a cesarean delivery under spinal anesthesia at Kayseri City Hospital. It will compare patients who receive granisetron as part of routine care to prevent nausea and vomiting with patients who do not receive preventive anti-nausea medicine. Granisetron use is decided by the treating anesthesiologist, not assigned by the study. Patients in the granisetron group receive the medicine within 5 minutes before or after spinal anesthesia. The main measurement is the total dose of ephedrine used during the operation. Ephedrine is a medicine used to treat low blood pressure. The study will also record low blood pressure at scheduled measurement points and nausea and vomiting during the operation. Patient enrollment is planned from October 15 to December 15, 2026.

Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension

The evidence-based pharmacologic treatments available for patients with heart failure with reduced ejection fraction (HFrEF) has been established over the last few decades of cardiovascular research. These treatments, termed Foundational Guideline-Directed-Medical Therapies (GDMT), prolong patient life, improve patient-reported symptoms, and reduce hospitalizations for heart failure. A direct effect of most medication classes encompassed within GDMT is the reduction in blood pressure due to their mechanisms of action. In addition, as patients with HFrEF become more advanced in their disease, a significant proportion develop hypotension related to pump failure and autonomic dysfunction, amongst other possible mechanisms. As a result, a significant proportion of HFrEF patients are not optimized on GDMT with hypotension as their limiting barrier that would otherwise have served to improve their heart function, heart failure symptoms, and mortality. Currently, there does not exist any evidence-based strategies to address the problem of hypotension in HFrEF patients who are not optimized on GDMT. Midodrine is an alpha-adrenergic agonist (α1-AR) that exerts its effects on peripheral venous and arteriolar vasculature to increase blood pressure. This medication has been used off-label by some clinicians in the hypotensive HFrEF population to increase blood pressure and has been reported to have beneficial effects in improving GDMT utilization as well as increasing left ventricular ejection fraction (LVEF) in published case reports/case series. There does not exist any randomized prospective data on the use of midodrine in the hypotensive HFrEF population. The investigators' objective is to complete the first open-label, randomized control trial of midodrine in the hypotensive HFrEF population to demonstrate feasibility in performing a trial in this patient population and to show efficacy in increasing blood pressure without associated harm. The results of this trial will be used as the foundation and rationale for future studies assessing the impact of midodrine use on GDMT utilization as well as hard cardiovascular outcomes in the hypotensive HFrEF population, including hospitalizations for heart failure and mortality.

Norepinephrine vs Phenylephrine During General Anesthesia

50 million patients undergo surgery each year in the United States. Postoperative mortality is considered the third leading cause of death worldwide. Hypotension during surgery have been linked to increased postoperative morbidity and mortality. Episodes of hypotension during surgery are associated with an increased risk of acute kidney injury, stroke, cardiac events and death. Treating or preventing hypotension during general anesthesia and major surgery was found to improve outcomes. At this time, it is unclear what is the best vasopressor to maintain blood pressure during surgery under general anesthesia. With this pilot pragmatic trial, the investigators will explore the impact of norepinephrine (NE) or phenylephrine (PE) on post-operative events in patients undergoing major surgery with general anesthesia and needing vasopressors infusion to maintain their systemic arterial pressure.

Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia

This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. The other group will receive the same dose of oxytocin as a slow infusion over 15 minutes. The researchers want to find out which method causes less drop in blood pressure and other heart-related changes, while still providing good contraction of the uterus and preventing excessive bleeding.

TSCS for Acute SCI

This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.

Peripheral pULSe Assessment and Arterial pRessure (PULSAR)

This prospective multicenter observational study aims to investigate the relationship between palpable peripheral pulses and simultaneously measured arterial blood pressure in adult patients with circulatory shock or impending circulatory failure. Peripheral pulse palpation is routinely used in emergency medicine, trauma care, critical care, and cardiopulmonary resuscitation as a rapid clinical assessment of circulation. However, the association between palpable pulses and actual arterial blood pressure remains poorly validated. Patients treated in emergency departments, intensive care units, operating rooms, and other acute care settings will undergo routine pulse palpation at predefined anatomical locations including carotid, femoral, and radial arteries. Simultaneously measured non-invasive and/or invasive arterial blood pressure values will be recorded from routine clinical monitoring systems. Additional clinical variables relevant to circulatory status will also be collected. The study seeks to define blood pressure thresholds associated with pulse palpability and evaluate the agreement between invasive and non-invasive blood pressure measurements in patients with circulatory shock.

Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU)

Postoperative hypotension in the post-anesthesia care unit (PACU) is common and linked to adverse outcomes. The Hypotension Prediction Index (HPI) predicts hypotensive events intraoperatively, but its PACU application is unexplored. This study aims to investigate the effectiveness of HPI-guided monitoring in preventing PACU hypotension.

Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension

Arterial puncture is a common procedure in the management of hospitalized patients. It is most often performed at the level of the radial artery and allows arterial blood gas analysis. The success rate of arterial puncture varies widely in the literature. This procedure is moderately painful and may cause significant discomfort, particularly in cases of repeated attempts. First-attempt success is therefore important to reduce both pain and the risk of local complications associated with multiple punctures. In routine practice, arterial puncture is performed using manual palpation of the radial artery, typically by a trained nurse. In case of failure, a physician may attempt the procedure, often using ultrasound guidance. However, ultrasound is not routinely used and requires specific training and organizational protocols for nurse use. In hypotensive conditions, such as shock, the radial pulse may become difficult to palpate, making arterial puncture more challenging when using conventional techniques. The Blood'up device (Arterya, Hérouville, France) is a non-invasive device currently under development that assists in arterial localization. It is applied to the wrist and projects a light signal indicating the position of the artery. This localization is based on ultrasound technology using piezoelectric sensors integrated into the device. The aim of this study is to evaluate the effectiveness of the Blood'up device for radial artery localization in healthy volunteers, both under physiological conditions (normal blood pressure) and under simulated hypotensive conditions.

Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.

Perfusion Index and Spinal Hypotension in Day-Case Knee Arthroscopy

This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy. Spinal anesthesia is a widely preferred technique for lower extremity surgeries, including knee arthroscopy. However, sympathetic blockade during spinal anesthesia frequently leads to significant hemodynamic instability, particularly hypotension, which can result in adverse perioperative outcomes. While age and baseline blood pressure are traditional risk factors, they often fail to accurately predict the onset of hypotension in healthy populations. The perfusion index (PI), a non-invasive parameter measured via pulse oximetry, reflects peripheral vascular tone and baseline sympathetic activity. An elevated baseline PI indicates baseline vasodilation and a higher susceptibility to sympathectomy, potentially offering an early and non-invasive prediction of SAIH before the hemodynamic collapse occurs. The primary outcome of the study is the incidence of spinal anesthesia-induced hypotension (defined as a mean arterial pressure \< 65 mmHg or a decrease in systolic blood pressure \> 25% from baseline). Secondary outcomes include the onset time of sensory block, and intraoperative ephedrine and fluid requirements.

Treatment of Orthostatic Hypotension in SCI

The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.

Prediction of Risk of Hypotension in Hemodialysis

The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).

Internal Jugular Vein Collapsibility Index for Predicting Post-Induction Hypotension

This study aims to investigate whether the Internal Jugular Vein Collapsibility Index (IJV-CI), measured via ultrasonography, can predict hypotension (low blood pressure) that occurs after the induction of general anesthesia. Researchers will measure the diameter of the internal jugular vein in patients before surgery and compare these measurements with the blood pressure changes during the first minutes of anesthesia. The goal is to determine if IJV-CI can be used as a reliable, non-invasive tool to identify patients at higher risk of developing anesthesia-induced hypotension.

Clinical Validation of Vital-PICASO for Predicting Hypotension Within 24 Hours in General Ward Inpatients

This retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension within 24 hours using vital-sign data from adult general ward inpatients. Electronic medical record data from patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital were retrospectively reviewed. Hypotension was defined as systolic blood pressure below 90 mmHg. Eligible data were classified as hypotension-positive or hypotension-negative according to predefined reference-standard criteria. Vital-PICASO was applied to the selected vital-sign datasets, and the software-generated hypotension risk scores were compared with the reference-standard classifications. Predictive performance was evaluated separately using data that included oxygen saturation and data that excluded oxygen saturation. Because the study used previously collected medical records, there was no direct participant contact and the software results were not used to guide patient care.