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Hypothermia clinical trials

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NCT ID: NCT02042625 Completed - Hypothermia Clinical Trials

Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study

Start date: April 2014
Phase: N/A
Study type: Interventional

Low body temperature (hypothermia) is often observed in anesthetized patients. Mild hypothermia increases complications such as surgical blood loss, postanesthesia recovery and the duration of hospitalization. To assess body temperature and minimize hypothermia-related complications, it is important to have accurate and reliable methods of measuring intraoperative core temperature. Common practice is to insert a nasopharyngeal (back of the throat from the nose) probe through one of the nostrils. However, there is no consensus or guideline regarding how deep the nasopharyngeal probe needs to be inserted. This study is being done to determine the insertion depth (or range of depths) that best approximates core temperature, which is temperature of the vital organs, e.g. heart, liver and lungs. Participation in the trial will occur on the day of surgery. The subject will be asked to breathe through one nostril and then the other before receiving anesthesia. The less congested nostril will be selected for study. If there is no difference, then the investigator will use the right nostril. Once under anesthesia, an esophageal temperature probe will be inserted to serve as a reference core temperature, which is used routinely in surgery. Then the nasopharyngeal probe will be inserted into the nostril. Both nasopharyngeal and esophageal temperatures will initially be recorded 45 minutes after anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time, until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal and esophageal temperatures obtained.

NCT ID: NCT02036034 Completed - Clinical trials for To Prevent Hypothermia During Opthalmology Surgery.

Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.

NCT ID: NCT02031159 Completed - Hypothermia Clinical Trials

Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring

Start date: October 2013
Phase: N/A
Study type: Observational

Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.

NCT ID: NCT02011568 Completed - Cardiac Arrest Clinical Trials

Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients

CAPITALCHILL
Start date: August 2013
Phase: N/A
Study type: Interventional

This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity. The primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.

NCT ID: NCT01994772 Completed - Cardiac Arrest Clinical Trials

Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm

HYPERION
Start date: January 26, 2014
Phase: N/A
Study type: Interventional

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock. There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

NCT ID: NCT01979848 Completed - Prostate Cancer Clinical Trials

MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

Start date: June 2013
Phase: N/A
Study type: Observational

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand: 1. How effectively the tissues for continence and sexual function are cooled within the pelvis. 2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and 3. Determine if the endorectal balloon can be re‐designed for improved QOL outcomes in men. This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non‐invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non‐invasive technique, and answer formidable questions of the effectiveness of hypothermic cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

NCT ID: NCT01965067 Completed - Clinical trials for Underdosing of Other General Anesthetics

Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex

Start date: October 2013
Phase: Phase 4
Study type: Interventional

The primary efficacy endpoint is the time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition. Secondary endpoints include time from the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, vital signs [heart rate and blood pressure] at pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of residual neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse events during mild hypothermia and the normal thermal condition. We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish the efficacy of sugammadex.

NCT ID: NCT01946802 Completed - Cardiac Arrest Clinical Trials

Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

Start date: December 2014
Phase:
Study type: Observational

Current guidelines recommend the use of sedatives and neuromuscular blocking agents to avoid shivering during therapeutic hypothermia in cardiac arrest victims. Therefore, it is difficult to detect seizure and the frequent or continuous EEG monitoring is recommended. However, it is difficult to follow this recommendation in most clinical situations due to the lack of specialized devices and persons. The purpose of this study is whether SEDline (frontal 4-channel EEG device) has a diagnostic value to detect seizure during therapeutic hypothermia in cardiac arrest victims.

NCT ID: NCT01913340 Completed - Clinical trials for Hypoxic-ischemic Encephalopathy

Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)

NEATO
Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.

NCT ID: NCT01913041 Completed - Hypothermia Clinical Trials

An Epidemiology Survey on the Incidence of Perioperative Hypothermia

Start date: August 2013
Phase: N/A
Study type: Observational

- The purpose of this study is to understand and grasp the incidence rate of hypothermia during perioperative period of elective operations under general anaesthesia in Beijing. - The purpose of this study is to carry out a subgroup analysis on the survey data and explore the high-risk factors for the incidence of hypothermia.