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Hypothermia clinical trials

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NCT ID: NCT02467777 Completed - Hypothermia Clinical Trials

Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries

Start date: June 2015
Phase: N/A
Study type: Interventional

Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.

NCT ID: NCT02436382 Completed - Hypothermia Clinical Trials

Hypothermia and the Effect of Ambient Temperature

HEAT
Start date: February 2015
Phase: N/A
Study type: Interventional

Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.

NCT ID: NCT02422758 Active, not recruiting - Hypothermia Clinical Trials

Prewarming Effect in Preventing Perioperative Hypothermia

Start date: May 2015
Phase: Phase 3
Study type: Interventional

Perioperative hypothermia brings numerous and recognized postoperative complications. Active warming intraoperatively helps to maintain body temperature in the postoperative period, but there are few studies in Brazil, assessing the effect of prewarming in maintaining normothermia. It is believed that prewarming with forced air warming system keep the body temperature during intra and post-operative. This study aims to evaluate the effect on prewarming maintaining body temperature of patients undergoing elective surgery of Gynecology specialty using the forced air warming system. The study is experimental design, controlled type randomized clinical trial, with simple blinding for patients. Eighty adult patients undergoing gynecological surgery in the art, with a surgical time of at least an hour will be randomized and allocated into experimental groups - prewarming system with forced air warming system for 20 minutes, and control - Prewarming with sheet and blanket for 20 minutes. The patients will be kept warm during the anesthetic-surgical procedure. The measurement of temperature will be using a tympanic thermometer. Participants will be followed from receiving the surgical center to the end of surgery. Data will be recorded in validated instrument. Data analysis will be used the Model Linear Mixed Effects and the Structure Error Auto-Regressive.

NCT ID: NCT02414191 Completed - Hypothermia Clinical Trials

Feedback on Perioperative Temperature Management and Patient Outcomes: Three-arm Trial to Compare Feedback

Start date: February 2015
Phase: N/A
Study type: Interventional

The investigators aim to assess the impact of benchmarked and ranked feedback on anesthesiologists' perioperative temperature management and subsequent patient outcomes.

NCT ID: NCT02411877 Withdrawn - Ischemic Stroke Clinical Trials

REperfusion With Cooling in CerebraL Acute IscheMia II

RECCLAIM-II
Start date: February 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients who have undergone hypothermia to those who have not.

NCT ID: NCT02395276 Not yet recruiting - Child Clinical Trials

Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury

Coolheart
Start date: April 2015
Phase: N/A
Study type: Interventional

Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period. Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound. In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.

NCT ID: NCT02390999 Completed - Cardiac Arrest Clinical Trials

Neurological Prognostication of Patients in Therapeutic Hypothermia After Cardiac Arrest

Start date: March 2013
Phase: N/A
Study type: Interventional

3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest patients. The investigators are challenged in our attempt to predict outcome of these patients by both low body temperature in itself and the sedative and relaxing drugs used to keep the patient in a coma. This study is a substudy in a large international multicenter randomized trial that investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays standard of 24 hours. In this substudy the investigators will approach early prediction of neurological outcome using a combination of new examinations backed up by well established ones to engage this challenge from different angles and find a battery of combined examinations, that together will enable us to accurately predict outcome at an earlier stage. Our examinations have been chosen from the three fields of neurophysiology, biochemistry and neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP), biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic reliability.

NCT ID: NCT02388789 Completed - Clinical trials for Perpherial Hypothermia

Foot Skin Temperature and Balance Control

Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether mechanoreceptor sensitivity of the sole of the feet increases with increased foot temperature and how a heightened sensation may improve characteristics of balance control and gait. As an extension, the investigators also want to determine whether lower limb movement is an efficient activity of increasing foot temperature. There are several objectives of this study. The investigators want to determine the effect of active recovery (via lower limb movements) on increasing plantar temperature, determine the effect of increased plantar temperature on plantar sensation and determine the effect of increased plantar sensation on balance control and gait characteristics. Participants will be asked to complete various tasks under different conditions. Conditions include decreased feet temperature via ice bath emersion, baseline feet temperature (participant's normal temperature after a ten minute equilibration period), and increased feet temperature via active movement of the lower limb. Tasks include walking across the room, performing active movement of the lower limb and a 10 minute treadmill walk. Gait movement will be collected with a three-dimensional motion capture system (Optotrak) and force plates. Feet temperature and sensation information will be collected with a temperature probe (infrared) and monofilaments.

NCT ID: NCT02387398 Terminated - Cardiac Arrest Clinical Trials

Early Coronary Angiography Versus Delayed Coronary Angiography

PEARL
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories 1 or 2) at discharge.

NCT ID: NCT02387385 Completed - Clinical trials for Neonatal Encephalopathy

Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

HELIX
Start date: August 2015
Phase: N/A
Study type: Interventional

Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately one million babies die from neonatal encephalopathy in low and middle-income countries and a quarter of these deaths occur in India. In the past decade, a number of clinical trials in high-income countries has shown that cooling therapy along with optimal neonatal intensive care reduces death and neurodisability after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after neonatal encephalopathy in all high income countries, including the UK. Although the burden of neonatal encephalopathy is far higher in low and middle-income countries, the safety and efficacy data on cooling therapy from high income cooling trials cannot be extrapolated to these settings, due to the difference in population co-morbidities and sub-optimal neonatal intensive care. The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6 hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after neonatal encephalopathy in public sector neonatal units in India. A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from the participating centres in India over an 18 to 24 month period. The babies will be randomly allocated to whole body cooling or usual care. The cooling therapy will be achieved using an approved cooling device (Tecotherm) that is already in clinical use in the UK and in India. MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is death or moderate/severe neurodisability at 18 months.