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NCT07421882
The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients with return of spontaneous circulation (ROSC). The study aims to assess feasibility, fidelity, acceptability, and safety of initiating cooling in the field by emergency medical services (EMS) prior to hospital arrival. Results will inform the design of a larger definitive trial to determine the clinical effectiveness of early pre-hospital TTM in improving neurological outcomes.
NCT07219290
A litter is often needed to extract a person from an austere environment like the wilderness or from confined, urban spaces. A horizontal litter is generally assumed to be better for patient care, but often makes for a more difficult, if not impossible, evacuation from some settings such as confined space rescue, cave rescue, or wilderness rescue when the litter must be moved up or down a cliff with an undercut edge. A litter in a vertical orientation is easier to move in these situations, which may expedite movement towards definitive care. In some wilderness rescue circles, the mantra is that movement IS definitive care. It is already known that lying flat on the ground negatively affects pulmonary function compared to a sitting baseline.1 It is possible that a vertically oriented litter is better for a subset of patients with respiratory issues than a horizontal litter. The investigators hypothesize that pulmonary function measured by FEV1, FVC, and FEV1/FVC, is better in simulated patients in a vertically oriented litter compared to a horizontally oriented one.
NCT07150559
The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 306 participants diagnosed with acute type A aortic dissection (ATAAD) from 7 hospitals in China. All patients receive total arch replacement (TAR) combined with frozen elephant trunk (FET) implantation and are randomized to Group 1 (arch-clamping technique under mild hypothermia), Group 2 (arch-clamping technique under moderate hypothermia) and Group 3 (Sun's procedure using bilateral antegrade cerebral perfusion) in the ratio of 1:1:1. After a 1-year follow-up, the validity and safety of the mild hypothermic arch-clamping technique for ATAAD was evaluated via the incidence of major adverse events including death, renal replacement therapy, stroke, and paraplegia, as well as times of circulatory arrest, cardiopulmonary bypass, and mechanical ventilation, and length of ICU stay.
NCT07028372
Less than 10% of patients eliciting out-of-hospital cardiac arrest (OHCA) survive, although 30% can be resuscitated by Emergency services before admission in Intensive Care Units (ICU). The majority succumb to Post-Cardiac Arrest Syndrome (PCAS). PCAS is associated with high mortality (60-70%) and morbidity. One proposed method of preventing the neurological and cardiac consequences of PCAS is to lower the body temperature to 33°C as quickly as possible. This approach is known as therapeutic hypothermia or Targeted Temperature Management (TTM). The Vent2Cool system, developed by Orixha, is a novel approach that enables the rapid induction of therapeutic hypothermia by using hypothermic Total Liquid Ventilation (TLV) to reach a protective temperature of 33°C within minutes. The OverCool feasibility study, which started in April 2025, is designed to validate the clinical performance and safety of an ultra-rapid cooling approach combining ultra-rapid hypothermia induction using the Vent2Cool system, and maintenance and rewarming using the ArcticSun system. The AfterCool study aims to evaluate long-term outcomes during a five-year follow-up of cardiac arrest survivors who were treated with ultrarapid cooling in the OverCool study.
NCT07470801
Inadvertent intraoperative hypothermia is one of the most common complications in patients undergoing anesthesia. This condition is strongly associated with several adverse clinical. At Siriraj Hospital, a previous study revealed a high incidence rate of 74.4%, with only 16.3% of patients receiving intraoperative temperature monitoring. In response to these findings, Siriraj Hospital implemented a perioperative temperature management guideline in July 2024. However, it remains to be evaluated whether the implementation of this protocol has led to a meaningful change in clinical practice. The primary concern is whether the adherence to temperature monitoring for surgeries exceeding one hour has improved from the historical rate of 16.3%, and subsequently, whether this has resulted in a decreased incidence of hypothermia.
NCT07467681
This prospective observational study aims to evaluate the association between perioperative hypothermia and sevoflurane consumption in elderly patients undergoing hip arthroplasty under general anesthesia. Patients aged 65 years and older will be included. Perioperative body temperature and anesthetic consumption will be recorded, and the relationship between hypothermia and anesthetic requirements will be analyzed. The findings may help clarify whether hypothermia influences anesthetic depth monitoring and anesthetic consumption in elderly surgical patients.
NCT07453264
Maintaining the infant's body temperature (thermoregulation), particularly in the first hour after birth, is critical for the newborn's survival and adaptation to the environment. It is hypothesized that the implementation of a thermoregulation bundle will lead to a faster stabilization of physiological parameters and will positively influence the initiation and overall success of breastfeeding. To this end, this study will examine the effects of a thermoregulation bundle applied at birth on the physiological parameters of newborns (vital signs such as body temperature, respiratory rate, heart rate, and oxygen saturation) and its impact on breastfeeding.
NCT07428772
This randomized controlled study will evaluate the effectiveness of an online Watch-Summarize-Question-Ask (WSQA) learning method on nursing students' knowledge, skills, attitudes, and behaviors related to patient fall prevention and management. Sixty-six nursing students will be randomly assigned to intervention and control groups. Both groups will receive standard patient safety education, while the intervention group will additionally participate in an online, evidence-based fall prevention training program structured according to the WSQA method, including video-based learning, summarization, question generation, and interactive discussions. Outcomes will be assessed using validated instruments measuring fall management knowledge, self-efficacy, attitudes toward fall prevention, care planning performance, and student satisfaction. The study aims to determine the effectiveness of an innovative educational approach to improve fall prevention competencies and enhance the quality and safety of nursing care.
NCT06129825
Warfighter Performance Optimization in Extreme Environments remains an area of important and intense investigation, with the following goals: (1) Optimize, sustain and augment medical readiness and physiological/ psychological performance in extreme and hazardous military operational environments and (2) develop joint DoD countermeasures and guidance to sustain performance, assess physiological status, and reduce injury risk in extreme and hazardous operational environments. Successful and safe outcomes in extreme and hazardous operational environments require that warfighters maintain optimum cognitive and exercise performance during physiologic stress. Extreme environmental conditions encountered in such environments include warfighter exposure to hypoxia and hypothermia, alone or in combination. Both hypoxia and hypothermia undermine O2 delivery system homeostasis, imposing dangerous constraints upon warfighter cognitive and exercise capacity. While red blood cells (RBCs) are commonly recognized as O2 transport agents, their function as a key signaling and control node in O2 system delivery homeostasis is newly appreciated. Through O2 content-responsive modulation of RBC energetics, biomechanics, O2 affinity and control of vasoactive effectors in plasma - RBCs coordinate stabilizing responses of the lung, heart, vascular tree and autonomic nervous system - in a fashion that maintains O2 delivery system homeostasis in the setting of either reduced O2 availability (hypobaric hypoxia) or increased O2 demand (hypothermia). Human RBCs demonstrate adaptive responses to exercise, hypoxia and hypothermia - these changes are commonly appreciated as a key element enabling high altitude adaptation. However, under conditions of hypoxia and hypothermia, without prior adaptation, RBC performance is adversely impacted and limits the dynamic range of stress adaptation for O2 delivery homeostasis - therefore limiting warfighter exercise capacity and cognitive performance in extreme environments, such as during acute mountain sickness.
NCT06788925
Here's a concise summary in English without the numbers: Hypothermia is defined as a core temperature below 35°C and occurs when the body loses more heat than it produces. It is classified by severity: mild (32-35°C), moderate (28-32°C), and severe (\<28°C). Trauma patients are particularly vulnerable, as hypothermia can affect cardiac, pulmonary, neurological, and coagulation systems, contributing to the "lethal triad" of metabolic acidosis, coagulopathy, and hypothermia, which increases early mortality risk. Shivering, a key sign of hypothermia, significantly raises oxygen consumption, making its prevention during prehospital care critical. Passive warming measures, such as insulating survival blankets, are commonly used to prevent heat loss in emergencies. These blankets help maintain body temperature, protecting victims from cold and wind. Hypothermia prevalence among trauma patients on hospital arrival is high, emphasizing the importance of prehospital measures to limit its impact. However, active warming systems are often impractical in prehospital settings, leaving passive methods as the primary strategy.
NCT02811432
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care. The primary aim is to examine the impact of KMC initiated before stabilisation on mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before stabilisation will have a 25% overall reduction in mortality within 7 days compared to neonates allocated to receive standard care.
NCT07307521
This study aims to improve the safety and care of patients in the Intensive Care Unit (ICU) by using artificial intelligence (AI) to analyze video monitoring. ICU patients often face serious risks such as delirium, accidental removal of breathing tubes or lines, and sleep problems. These events can lead to medical emergencies, longer ICU stays, higher costs, and worse outcomes. To address these challenges, we will place a small video camera above each ICU bed. The camera will record patient movements, body activity, and sleep patterns. At the same time, routine medical monitors will record heart rate, blood oxygen levels, and other vital signs. Noise levels in the room will also be measured. All these data help us understand the patient's behavior and condition more accurately. The video recording does not involve extra treatment or additional procedures. All data are collected passively and safely. Patient privacy is strictly protected: the system will blur faces or replace them with digital avatars, and any information that could identify the patient or the environment will be masked. All videos are stored securely inside the hospital and are processed only after privacy protection. Using these recordings, an AI model will be trained to recognize early warning signs of dangerous situations. For example, the system may detect early movements that suggest the patient is becoming agitated, confused, or trying to remove medical tubes. It may also identify severe sleep disturbance that may lead to delirium. If the AI can recognize these early changes, medical staff can intervene sooner and prevent harm. About 300 patients from Fudan University Zhongshan Hospital will participate. Participation is voluntary. Patients or families will sign an informed consent form before being enrolled. The study has three stages: Screening - understanding the study and signing consent. Data collection - video and medical monitor data are collected during the ICU stay. Follow-up - telephone or in-person follow-up at 1 month and 6 months after discharge to evaluate recovery, sleep, mental status, and overall safety. There are no direct medical risks from participating in this study because it only collects behavioral and monitoring data. The cameras do not interfere with treatment. Privacy and data security are the main considerations, and all measures strictly follow national laws and hospital regulations. Participants may benefit from earlier identification of dangerous situations, which may help prevent accidental tube removal, severe agitation, or other emergencies. Even if no direct benefit occurs, the information collected may help improve future ICU care by enabling safer and more accurate monitoring systems. Taking part in the study will not affect the patient's medical care. Patients may withdraw at any time without any consequences or loss of benefits. This study hopes to build a reliable AI tool that can assist nurses and doctors in recognizing early signs of trouble, improving safety, and enhancing the quality of care for ICU patients.
NCT00372268
During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described. The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are: * CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl * CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl * CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2% * CO2 dry and cold with direct intra-abdominal administration of Nacl The investigators use a new device (Aeroneb® Pro \[Aerogen® Company\]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).
NCT03157609
The present study aims to assess the accuracy of the SpotOn™ Zero-heat-flux-thermometry sensor in measuring core temperature in the paediatric population in the perioperative period.
NCT06025123
The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).
NCT06951269
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures. Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings. Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.
NCT01604317
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
NCT06283771
In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy
NCT06327893
Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.
NCT05269823
Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.