Vital Signs Monitoring

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Researchers are exploring two strategies for setting pressure support levels in patients receiving pressure support ventilation (PSV) in intensive care units. The study focuses on adults with acute hypoxic respiratory failure who need mechanical ventilation. It aims to compare the traditional method based on tidal volume (VT) and respiratory rate (RR) with a newer method using the pressure muscle index (PMI), which may better reflect patient inspiratory effort. This pilot trial will examine clinical outcomes and how well clinicians adhere to these strategies to guide future larger studies. The trial involves two treatment periods at two centers using a sequential cluster crossover design. The first 4-week period uses the VT/RR-targeted pressure support settings, followed by a 4-week washout, then a 4-week PMI-targeted period. In the VT/RR group, pressure support is adjusted to keep VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths per minute. In the PMI group, pressure support is adjusted to keep PMI between 0 and 2 cmH2O. Both groups receive standard mechanical ventilation care, including sedation and analgesia management, with adjustments made twice daily during PSV. Participants will be monitored daily until weaning, death, discharge, or 28 days after randomization. Data collected include ventilator settings, respiratory and hemodynamic parameters, sedation and analgesia levels, and clinical outcomes such as duration of mechanical ventilation and mortality. The study also includes clinician surveys about the acceptability and feasibility of the PMI-based strategy. This comprehensive approach will help assess the practicality of PMI-targeted pressure support in critical care settings.

Researchers are evaluating a predictive algorithm called the hypotension prediction index to optimize hemodynamic management during major vascular surgery, specifically abdominal aortic aneurysm repair. The study aims to compare this new method with standard cardiovascular parameter-based care to understand if it can better manage blood pressure during surgery. The trial is led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and uses a randomized, single-masked design. Participants are divided into two groups: the control group receives hemodynamic optimization based on standard cardiovascular parameters displayed on the Hemosphere platform, with drugs and fluids administered according to mean arterial pressure and stroke volume variation. The experimental group is managed using the hypotension prediction index to guide drug and fluid administration proactively. This study focuses on the intraoperative period during aortic surgery. During the surgery, researchers will monitor blood pressure and calculate the time-weighted average of mean arterial pressure below 65 mmHg as the primary outcome. Participants undergo continuous hemodynamic monitoring to assess the effectiveness of both approaches. The trial continues until the end of surgery, with no mention of extended follow-up periods. The total duration for participants is limited to the surgical procedure timeframe.

Bone tumor surgery often leads to significant blood loss, which can cause postoperative anemia and increase the risk of complications and affect long-term survival. Researchers are evaluating the effect of acute normovolemic hemodilution (ANH) combined with goal-directed fluid therapy (GDFT) in patients undergoing bone tumor surgery. This study aims to determine if ANH can improve hemoglobin levels after surgery, addressing previous uncertainties about ANH's clinical benefits when fluid management is carefully controlled. Participants are randomly assigned to one of two groups. In the ANH group, blood is drawn after anesthesia and replaced with a fluid to maintain blood volume, followed by GDFT during surgery. In the standard care group, only GDFT is applied throughout the surgery without ANH. The trial carefully monitors fluid management strategies to assess the impact of ANH on patient outcomes. Throughout the study, participants will have their hemoglobin levels measured on the first day after surgery as the primary outcome. Secondary measures include blood loss, blood transfusion rates, fluid volume during surgery, coagulation tests, and infections up to seven days post-surgery. The study includes preoperative assessments, intraoperative monitoring, and postoperative follow-up to evaluate safety and efficacy over the hospital stay period.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

Researchers are studying preterm infants born between 25 and 32 weeks of gestation to compare two methods of incubator temperature control and their effects on infant weight growth and health. The study is based on earlier findings that lower body temperature on admission relates to higher illness and death rates in preterm infants. It aims to see if using a new software to calculate personalized air temperature in incubators can improve growth and reduce side effects compared to the traditional skin temperature control method. The study compares two incubator control methods: air temperature control (ATC), which uses software to set air temperature to reduce body heat loss to zero, and skin servocontrol (SSC), which adjusts incubator temperature based on the infant's skin temperature. Both methods are evaluated in closed incubators for preterm infants. The trial randomly assigns infants to one of these two methods to study their effects during the first 10 days of life. Participants will be monitored for changes in body weight until day 10, along with comfort, thermal stress, and humidity challenges. The study also tracks neonatal illness occurrences up to 40 weeks of amenorrhea and length of hospital stay until discharge or 40 weeks of amenorrhea. Parents provide written consent, and infants are included within the first day of life. The study continues through hospitalization, assessing health outcomes and safety related to the incubator settings.

Researchers are evaluating the safety and performance of the Glean Urodynamics System for monitoring the lower urinary tract. This prospective, open-label, single-arm interventional trial focuses on both in-clinic and extended monitoring periods. The study aims to assess how well this device works in clinical settings and during continued use outside the clinic. Participants will have the Glean Urodynamics System inserted, which includes a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software applications. Initially, monitoring occurs in-clinic, followed by discharge with the bladder sensor in place for up to 24 hours of additional monitoring at home. The sensor is removed within 24 hours after insertion. Seven days following sensor removal, participants provide a urine sample and receive a follow-up phone call 14 days after the device is removed. During the study, participants will undergo monitoring with the device and provide a urine sample after one week. Researchers will track any adverse events related to the Glean Urodynamics System from the time of enrollment until 14 days after device removal. Follow-up phone calls help ensure participant safety and gather additional information. Participation duration includes the initial monitoring period, sample collection, and follow-up, lasting a few weeks in total.

Rheumatoid arthritis (RA) is a systemic disease mainly affecting joints but can involve other organs, causing inflammation, joint pain, fatigue, and increased heart disease risk. Exercise is important for managing RA due to decreased muscle strength, endurance, and aerobic capacity. Researchers are evaluating the 6-minute step test (6MST) as an alternative to the commonly used bicycle ergometer for assessing aerobic exercise capacity in RA patients, aiming to provide a practical and effective tool for individualized rehabilitation planning. This study involves one group of RA patients who will undergo two tests to measure aerobic capacity: the 6-minute step test and the bicycle ergometer test. The bicycle ergometer test uses equipment to monitor heart rate, oxygen consumption, and blood pressure while the patient cycles as long as they can. The 6MST measures exercise duration, step rate, and total steps, with heart rate, oxygen saturation, blood pressure, and fatigue recorded before and after the test. Researchers will compare results from both tests to determine the validity of the 6MST. Participants will be evaluated at Firat University Hospital. During each test, vital signs and fatigue levels are monitored closely. Data collected includes heart rate, blood pressure, oxygen saturation, and perceived exertion using the Modified Borg Scale. The study monitors how well the 6MST reflects aerobic capacity compared to the bicycle ergometer. Participation involves completing both tests with safety and comfort prioritized, and the total involvement duration varies based on individual test performance.

Continuous breath sound monitoring has the potential to provide anesthesiologists with real-time physiological information that is not captured by standard perioperative monitors. During general anesthesia, subtle changes in airflow or airway patency may precede clinically apparent respiratory compromise. Traditional auscultation is intermittent, subjective, and dependent on the operator's experience. Recent advances in electronic stethoscope technology enable continuous, high-fidelity acquisition of breath sound signals, allowing quantitative analysis and automated detection of abnormal respiratory patterns. In this prospective observational study, adult patients undergoing elective surgery under general anesthesia will have electronic stethoscope sensors placed on the anterior chest wall prior to induction. Breath sound signals will be continuously recorded throughout anesthesia and surgery. Signal acquisition parameters (sampling rate, filtering, and sensor placement) will be standardized across participants. All breath sound recordings will be synchronized with standard intraoperative monitoring data, including respiratory rate, tidal volume, capnography, pulse oximetry, and hemodynamic parameters. The synchronized dataset will allow temporal correlation between acoustic features and clinically documented respiratory events. Collected signals will undergo post-processing to extract quantitative acoustic features such as amplitude, frequency distribution, airflow-related patterns, and event-associated spectral changes. Episodes suggestive of abnormal respiration-such as diminished breath sounds, irregular airflow patterns, obstruction-like signatures, or apnea-like silent periods-will be identified and compared with clinical observations recorded by anesthesia providers. The study will also evaluate the feasibility of integrating continuous breath sound information into perioperative workflows, including the practicality of sensor placement, stability of recordings during surgical manipulation, and compatibility with existing monitoring systems. The overall goal of the study is to generate foundational evidence on the technical feasibility and clinical relevance of continuous breath sound monitoring under general anesthesia. Findings from this study may support future development of automated respiratory event detection tools and may contribute to safer perioperative respiratory management.

Researchers are collecting data from about 300,000 patients who undergo anesthesia or intensive care procedures at a scientific institute over a 10-year period. The goal is to create a detailed registry to support studies aimed at improving treatments and patient care in these fields. This observational study follows ethical guidelines and requires informed consent from participants. The study collects a wide range of information, including patient demographics, medical history, details about anesthesia and intensive care treatments, laboratory results, diagnostic tests, therapeutic procedures, patient satisfaction, and evaluation scales. All data will be anonymized before being added to the registry to protect patient privacy. Participants are observed during their hospital stay, from admission until discharge, which usually happens within 30 days. For some patients, follow-up by phone may occur after one year. Researchers analyze the data to understand patient outcomes related to anesthesia and critical care. Participation is voluntary, and no extra costs are expected for patients.