Active clinical trials for "Hypothermia"

This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.

A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost infant incubator called "IncuBaby" that consists of two components: a temperature sensor that can continuously monitor an infant's temperature, and a heated, enclosed area that can adjust internal temperature based on the feedback from the temperature sensor. This robust, low-cost device will allow for the individualized treatment of hypothermia with minimal intervention from the clinical staff. In this study, researchers intend to evaluate the efficacy of this incubator at QECH by comparing infants' temperatures before and after treatment, and calculating the proportion of time that the infants remain in a normothermic range after rewarming. During phase I of this study, the infants will be continuously monitored using the IncuBaby temperature sensor and a gold standard temperature monitor for up to 3 days. The accuracy of the IncuBaby temperature sensor will be determined by calculating the difference between the temperatures recorded by the temperature sensor and the commercial patient monitor at each point in time. During phase II of the study, infants in need of thermal care with an incubator will be treated with an IncuBaby device and their temperatures will be continuously monitored by both the temperature sensor of the IncuBaby device and a commercially available patient monitor. Care will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care. To determine the effectiveness of the IncuBaby device at warming infants, the temperatures of the infants will be compared before and after treatment for each subject. The proportion of time the device maintains the subject's temperature in a normal range will also be calculated.

To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.

Although data on cardioprotective effects (as profile of troponin I)of perioperative maintenance of normothermia during CABGs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and the control group receiving standard institutional care.

The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.

Sudden out-of-hospital cardiac arrest (OHCA) is a leading cause of death in Australia. The most common cause of OHCA is a heart attack. The current treatment of OHCA is resuscitation by ambulance paramedics involving CPR, electrical shocks to the heart, and injections of adrenaline. In more than 50% of cases, paramedics are unable to start the heart and the patient is declared dead at the scene. Patients with OHCA who do not respond to paramedic resuscitation are not routinely transported to hospital because it is hazardous for paramedics to undertake rapid transport whilst administering chest compressions and there is currently no additional therapy available at the hospital that would assist in starting the heart. However, a number of recent developments suggest that there may be a new approach to the resuscitation of this group of patients who would otherwise die. Firstly, Ambulance Victoria have recently introduced portable battery powered machines that allow chest compressions to be safely and effectively delivered during emergency ambulance transport. Second, The Alfred ICU will shortly be implementing a new protocol whereby the patient in cardiac arrest can immediately be placed on a heart-lung machine. This is known as extra-corporeal membrane oxygenation (ECMO). Third, the brain can now be much better protected against damage due to lack of blood flow using therapeutic hypothermia which is the controlled lowering of body temperature from 37°C to 33°C. Clinical trials have demonstrated that this significantly decreases brain damage after OHCA. Finally, The Alfred Cardiology service has an emergency service for reopening the blocked artery of the heart in patients who present with a sudden blockage of the heart arteries. This is currently not used in patients without a heart beat because of the technical difficulty of undertaking this procedure with chest compressions being undertaken. This study proposes for the first time to implement all the above interventions when patients have failed standard resuscitation after OHCA. When standard resuscitation has proved futile, the patient will be transported to The Alfred with the mechanical chest compression device, cooled to 33°C, placed on ECMO, and then transported to the interventional cardiac catheter laboratory. The patient will then receive therapeutic hypothermia for 24 hours. Subsequent management will follow the standard treatment guidelines of The Alfred Intensive Care Unit.

The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease. While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established. To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.

This study is a single-center, randomized, controlled, double-blind clinical trial. The main purpose of this study is to evaluate if hemoperfusion is sufficient to improve the prognosis of acute type A aortic dissection patients undergoing cardiopulmonary bypass and deep hypothermia circulatory arrest.

This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage. The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.

Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage (IPH) is common and associated with neurological deterioration and poor clinical outcome. Temperature modulation to hypothermia (Temperature, 32-34°C) has been associated with reduction or improvement of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. In this sense, we believe that the initiation of an ultra-early protocol of active temperature modulation or Targeted Temperature Management (TTM) to mild induced hypothermia (MIH, 32-34°C) may be associated with good safety and tolerability profile, less HG and cerebral edema after IPH by modulation of systemic and local inflammatory responses, so we hypothesize that TTM to MIH will be a safe/tolerable and effective therapy to limit HG and cerebral edema after IPH.