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NCT07659301
This study examines whether exposition to hyperbaric oxygen after a road-race simulation can help competitive cyclists recover and perform better the following day. Hyperbaric oxygen, which involves breathing oxygen inside a pressurized chamber, is used as a recovery method in elite and professional sport. Its effectiveness, however, remains controversial: despite this widespread use, there is a lack of solid scientific evidence that a single HBO session after strenuous endurance exercise actually improves recovery, or that clarifies how the amount of oxygen exposure influences any benefit. The study includes healthy male road cyclists between 18 and 40 years of age who compete at the national level in Belgium. After completing a fatiguing cycling session, each participant is randomly assigned to one of four groups receiving different levels of oxygen exposure during recovery. Two groups breathe oxygen under increased pressure inside a chamber at either 2.5 or 1.4 atmospheres absolute. A third group breathes oxygen at normal pressure. The fourth group receives a sham condition that reproduces the treatment setting without active oxygen exposure. The study is double-blind, meaning that neither the participants nor the researchers assessing the outcomes know which condition each participant receives. The main goal is to determine whether a single session of post-exercise HBO improves next-day endurance performance, and whether higher oxygen exposure produces greater effects. The researchers also collect blood samples and physiological measurements to better understand how the body recovers.
NCT06101628
The aim of this study was to determine the effect of gel nail application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of gel nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel nail application in a private beauty centre between July 2023 and July 2024. The minimum required sample size was calculated as 162 in G\*Power (3.1.9.2) programme (α=0.05 (two-way), 1-β=0.95). The data will be collected with the data collection form prepared in line with the literature.First, the age and smoking status of participants who meet the research criteria will be recorded on the data collection form. Then, the finger to which the gel nail polish will be applied and the control finger will be determined by drawing lots between the index fingers. Based on the result of this draw, gel nail polish will be applied to the left index finger of each participant, while the right index finger will be used as the control. Following the application of gel nail polish, SpO₂ and heart rate (HR) measurements will be obtained simultaneously from the left and right index fingers using pulse oximeters (POs). All measurements will be performed under standardized conditions: (1) participants will rest for at least 5 minutes before measurements, (2) their hands will be positioned at heart level, (3) ambient lighting and room temperature will be kept constant, and (4) participants will be instructed to remain still during measurements. These procedures will be applied consistently to all participants in order to minimize variability and enhance data reliability. The data obtained from the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 26.0 software.
NCT07261787
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation. This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (\< 28 weeks).
NCT07564050
The goal of this clinical trial is to evaluate the performance and physiological effects of different preoxygenation devices in healthy adult and pediatric volunteers (children aged 5-12 years). The study aims to determine how these devices influence oxygen delivery, airway pressure, and cardiopulmonary physiology during preoxygenation. The main questions it aims to answer are: * What fraction of inspired oxygen (FiO₂) is delivered by non-rebreather masks (NRM) compared to bag-valve masks (BVM) with and without positive end-expiratory pressure (PEEP)? * How do these devices differ in terms of generated PEEP, inspiratory effort, and their effects on lung ventilation and cardiac function? Researchers will compare NRM, BVM without PEEP, and BVM with PEEP (each with or without supplemental oxygen via nasal cannula) to evaluate differences in oxygenation and physiological effects. Participants will: * Complete multiple 3-minute preoxygenation sessions using each device in randomized order * Breathe spontaneously through each device, with or without additional oxygen via nasal cannula * Undergo non-invasive monitoring of oxygen concentration (FiO₂), respiratory parameters, airway pressures, and ultrasound assessment of the lungs, diaphragm, and heart * Perform a brief breath-holding maneuver to assess airway pressure generation
NCT03325959
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas. In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment. In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
NCT07538817
Oxygen administration is essential in the perioperative period to prevent hypoxia; however, excessive oxygen may cause hyperoxia and related complications. While pulse oximetry is effective in detecting hypoxemia, it is insufficient for identifying hyperoxia when SpO₂ exceeds 97%, often necessitating invasive arterial blood gas analysis. The Oxygen Reserve Index (ORI) is a noninvasive, real-time monitoring parameter reflecting moderate hyperoxic ranges (PaO₂ 100-200 mmHg) and provides early warning of oxygenation changes before SpO₂ alterations occur. Combined use of ORI and pulse oximetry may enable optimal oxygen titration and prevention of both hypoxemia and hyperoxemia. Laparoscopic nephrectomy is widely performed due to its clinical advantages. In our practice, low and normal fresh gas flow anesthesia are commonly used. Low-flow anesthesia offers benefits such as preservation of heat and humidity, reduced cost, and improved airway physiology. This study aims to determine optimal oxygenation levels during laparoscopic nephrectomy under low and normal fresh gas flow conditions using ORI monitoring.
NCT07228676
High-flow nasal oxygen (HFNO) is recommended as first-line treatment to prevent intubation in acute hypoxemic respiratory failure and to prevent reintubation after extubation. Accumulating data suggest that strong inspiratory efforts and their persistence are associated with HFNO failure. However, tools to monitor continuously and noninvasively inspiratory efforts are lacking. The investigators have developed an algorithm estimating noninvasively inspiratory efforts under HFNO. This pilot study aims at testing the feasibility of estimating inspiratory efforts in patients treated with HNFO.
NCT07514026
This prospective randomized study was conducted to evaluate the effects of low-flow and high-flow anesthesia on intracranial dynamics and cerebral oxygenation in patients undergoing laparoscopic hysterectomy in the Trendelenburg position. Intracranial pressure was assessed noninvasively using optic nerve sheath diameter (ONSD), and cerebral oxygenation was monitored using near-infrared spectroscopy (NIRS). Changes in these parameters were assessed under standardized pneumoperitoneum and positioning conditions, and comparisons between anesthesia flow groups were performed according to the predefined study protocol.
NCT07463586
The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia. The main question it aims to answer is: \- Does reduced cerebral oxygen consumption responsiveness during surgery increase the risk of postoperative delirium in older patients? Participants who are undergoing elective laparoscopic surgery under general anesthesia as part of their routine medical care will have brain oxygen levels measured during surgery using a non-invasive forehead sensor, and will be assessed for delirium for up to three days after surgery.
NCT04266665
Brain tumor surgery is commonly associated with different degrees of preoperative intracranial hypertension and surrounding tumor edema, elicited by tumor underlying pathophysiology. During craniotomy for brain tumor resection maintenance of hemodynamic stability and intracranial homoeostasis is of paramount importance. Disordered hemodynamics or adverse stress may activate the immune inflammation or neuroendocrine responses and lead to a surge of inflammatory mediators and stress hormones, which are implicated in secondary brain insults. Adverse physiological responses caused by intraoperative disordered hemodynamics or surgery-related damage, may lead to some secondary brain injury (such as cerebral edema or cerebral hemorrhage), aggravating damage to brain tissue and affecting the recovery from anesthesia, cognition and prognosis in patients. Prevention of secondary brain injury is a key-endpoint to improve clinical outcomes in glioma patients undergoing craniotomy. Alpha2-adrenoceptor agonists have been widely used for sedation, analgesia and anti-sympathetic actions for many years, but the definite evidence of their potential use as neuroprotectants has so far been confined to animal studies, yet the findings are inconsistent. Dexmedetomidine (DEX) has been demonstrated to be a new type a2 adrenergic receptor (a2-AR) agonist, which can selectively bind with the a1 and a2 adrenergic receptor, and playing a dual role by restraining the activity of sympathetic nervous and stimulating the vagus nerve. Dexmedetomidine (DEX) also plays an important role in in inhibiting inflammatory and neuroendocrine responses. Animal experiments showed that the right must have a dexmedetomidine neuro-protective effect. However, the brain-protective effect of dexmedetomidine in anesthesia of craniotomy resection of glioma has not been reported. Thus, the aim of this study was to explore the effect of dexmedetomidine on perioperative brain protection, as well as cerebral oxygenation and metabolic status aiming to provide a basis for clinical rational drug use in patients undergoing craniotomy resection of glioma.
NCT07099820
Colorectal cancer is a very commonly diagnosed malignancy worldwide, and surgical resection remains the mainstay of treatment. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care; minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication. AD is a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary from 1.7% to 29%. Reduced oxygen delivery-pre-, intra-, or post-operatively-can contribute to AD, while adequate oxygenation improves healing. Supplemental O₂ (FiO₂ 80%) has been shown to reduce AD risk after gastric surgery. Tissue oxygen delivery can be quantified by indexed oxygen delivery (DO2I), defined as ml/min/m² and determined by cardiac output, hemoglobin, and saturation. Pulse cardiac output (CO)-Oximeter® (Masimo), allow continuous non-invasive monitoring of these parameters. This prospective observational cohort study aims to explore the correlation between intraoperative DO2I and the risk of postoperative anastomotic dehiscence, using the non-invasive technologies described.
NCT07479511
This prospective observational study investigates the effects of intermittent hypoxic conditioning and real high-altitude exposure in lung transplant recipients compared with healthy controls. The study includes an eight-week home-based preparatory phase during which participants use a normobaric hypoxic tent with reduced oxygen concentration. Prior to this phase, all participants receive standardized training on the safe use of the equipment. During the preparatory period, daily vital parameters, including heart rate, oxygen saturation, and heart rate variability, are recorded using a sports watch and a pulse oximeter. Symptoms, adverse events, and subjective well-being are documented daily in an electronic diary. All data are transmitted to the study team via encrypted electronic systems, allowing continuous remote monitoring. At the end of the preparatory phase, participants undergo a clinical evaluation to confirm fitness for the expedition phase. The expedition phase consists of a monitored ascent of Aconcagua (6,971 meters). Before departure, all participants are required to attend a comprehensive safety, protection, and first aid training conducted jointly by the study team and professional expedition providers. The expedition is planned and led by an experienced international expedition company in cooperation with a local provider specializing in high-altitude mountaineering. The expedition includes arrival in Mendoza, preparatory procedures such as equipment checks and permits, followed by a staged ascent to base camp. Subsequent days involve rest periods and acclimatization hikes with the establishment of progressively higher camps. A summit attempt is planned after sufficient acclimatization, followed by descent to high camp. A weather-dependent buffer period is included before the final descent to the valley and return to Mendoza, where the expedition concludes. Total study participation is expected to last approximately 15 weeks, including about eight weeks of home-based preparation and approximately three weeks at altitude. A final follow-up examination is conducted 2 to 4 weeks after completion of the expedition, marking the end of study participation.
NCT06619717
The optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades. Initial landmark studies showed a decrease in the incidence of DNS with a single treatment and also with three treatments over the course of 24 hours. These two strategies have continued to be used widely without further evidence comparing them in a direct fashion. Retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments. The investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes.
NCT04519528
The purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent extracorporeal membrane oxygenation (ECMO), and their risk factors. The research will also assess the child health at 1 year after withdrawal from ECMO and in 2020 in terms of neurological state and quality of life.
NCT05440851
PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients. Utilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices. The platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes. Interventions will be evaluated within therapeutic domains. A domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies within the same patient. Once feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain. These adaptive analyses will compute the posterior probabilities of superiority, futility, inferiority, or equivalence for pre-specified comparisons within domains. Each of these potential conclusions will be pre-defined prior to commencing the intervention trial. Decisions about trial results (e.g., concluding superiority or equivalence) will be based on pre-specified threshold values for posterior probability. The primary outcome of interest, the definitions for superiority, futility, etc. (i.e., the magnitude of treatment effect) and the threshold values of posterior probability required to reach conclusions for superiority, futility etc., will vary from intervention to intervention depending on the phase of investigation and the nature of the intervention being evaluated. All of these parameters will be pre-specified as part of the statistical design for each intervention trial. In general, domains will be designed to evaluate treatment effect within four discrete clinical states: non-intubated patients, intubated patients with low respiratory system elastance (\<2.5 cm H2O/(mL/kg)), intubated patients with high respiratory system elastance (≥2.5 cm H2O/(mL/kg)), and patients requiring extracorporeal life support. Where appropriate, the model will specify dynamic borrowing between states to maximize statistical information available for trial conclusions. In this perpetual trial design, different interventions may be added or dropped over time. Where possible, the platform will be embedded within existing data collection repositories to enable greater efficiency in outcome ascertainment. Standardized systems for acquiring both physiological and biological measurements are embedded in the platform, to be acquired at sites with appropriate training, expertise, and facilities to collect those measurements.
NCT07222007
The aim of this retrospective cohort study is to compare the safety and efficacy of induction agents for tracheal intubation in critically ill adult patients.
NCT05154071
Current evidence suggest that regrouping patient supported by veno-venous ECMO in high-volume centre could improve outcome. A dedicated ECMO unit was implemented in Dijon. The objective of the present study was to evaluate the implementation of this unit. The hypothesis was that patient taken care within this structured care system would have lower mortality. This research comprises a retrospective observational study conducted in Dijon university hospital
NCT07369232
This study is called CHE-OX-ANT (Cerebral Hemodynamic Effects of Oxygen and Antioxidants). It is a single-center, academic research project led by the Department of Intensive Care at Erasme Hospital (Université Libre de Bruxelles). The study focuses on understanding how the brain and blood vessels react when a person breathes pure oxygen and how these effects may be influenced by giving vitamin C, an antioxidant. Oxygen is one of the most common treatments in hospitals. While it can be life-saving, too much oxygen may sometimes cause harmful effects, such as oxidative stress (an imbalance between damaging molecules called free radicals and the body's defenses). Antioxidants like vitamin C may help counteract these effects. The goal of the study is to examine how a short period of high oxygen (30 minutes of 100% oxygen through a mask) affects cerebral hemodynamics, microcirculation, microperfusion, blood markers (levels of oxidative stress, antioxidant activity, and microparticles). The study will also test whether giving vitamin C beforehand changes these responses compared to a placebo (saline solution). Each volunteer will participate in two sessions, one week apart. Before each session, participants will receive either vitamin C (given intravenously) or a placebo (saline). They will not know which one they receive. Then, they will breathe 100% oxygen for 30 minutes through a facial mask. Measurements will be taken at three times: before oxygen (t0), just after oxygen (t1), and 1 hour later (t2). These include: ultrasound of the brain's blood flow (transcranial Doppler), measurements of skin perfusion and blood samplings.
NCT07366541
High-Flow Nasal Cannula (HFNC) therapy is widely used to treat acute respiratory failure. However, predicting therapy failure remains challenging as conventional indices rely on intermittent measurements and cannot provide continuous, objective monitoring. Electrical Impedance Tomography (EIT) enables non-invasive, real-time assessment of regional lung ventilation. This study evaluated whether an EIT-derived Flow Index (FI) could predict HFNC therapy failure within 48 hours.
NCT06359106
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.