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Hypothermia clinical trials

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NCT ID: NCT06370624 Active, not recruiting - Clinical trials for Encephalopathy, Hypoxic-Ischemic

PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.

PEDI-REAVASC
Start date: January 17, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores. The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours. A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned.

NCT ID: NCT06141252 Active, not recruiting - Clinical trials for Out-Of-Hospital Cardiac Arrest

Benefit of Hypothermia in OHCA Complicating AMI

Hypothermia
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.

NCT ID: NCT04761224 Active, not recruiting - Clinical trials for Prostatic Hypertrophy

Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser

THERMHOLEP
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

For the treatment of benign prostatic hyperplasia (BPH), 2 types of endoscopic surgery are currently performed: transurethral prostate resection (TPR), the reference surgery, and laser prostatic enucleation (LPE). These procedures can be performed under general anesthesia, or local anesthesia, such as spinal anesthesia. The EPL or RTUP procedure requires the instillation of continuous intra-vesical fluids throughout the procedure. These 3L bags are often kept at the ambient temperature of the operating room (around 17°C): the temperature of the instilled solution is therefore much lower than the average body temperature of the patient (37°C). Thus, and by heat exchange, it often results in per and postoperative hypothermia, which is all the more frequent and profound the longer the duration of the operation. In spite of the usual procedures of warming by heating blanket, the prevalence of hypothermia, defined as a body temperature < 36°C, is 53.5% during surgical procedures. This hypothermia is all the more frequent and profound the older the patient is and the longer the duration of anesthesia. Several studies have shown that hypothermia is particularly frequent during abdomino-pelvic surgery, notably due to pathophysiological phenomena induced by anesthetic procedures. Indeed, general anesthesia, or major locoregional anesthesia, disrupts the thermoregulation center upon anesthetic induction, with alteration of peripheral vasoconstriction and tremor capacity, leading to a rapid redistribution of body heat from the center to the periphery. Through exchanges with the environment, this results in a rapid linear decrease in central body temperature that exceeds the metabolic energy produced. However, anesthetic procedures are not the only cause of hypothermic intraoperative phenomena. It has been shown that the decrease in body temperature associated with most genitourinary endoscopic procedures is multifactorial, taking into account the patient's body mass, the volume of fluids instilled, and the type and duration of the operation.

NCT ID: NCT04667000 Active, not recruiting - Clinical trials for Cesarean Section Complications

The Effect of Forced Air Warming During Caseraen Section on Maternal Hypothermia: Randomized Controlled Trial

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

During the cesarean section; Hypothermia can be seen due to reasons such as anesthesia, premedication drugs, cold operating room environment, exposure of tissues and organs, and use of cold intravenous fluids. Hypothermia associated with cesarean may affect maternal and fetal health negatively. As a result of hypothermia, coagulopathy, infection, undesirable cardiac events that cause an increase in oxygen consumption, delay in postoperative recovery and wound healing, postoperative nausea and vomiting, chills and relief may be observed in the mother. Newborns born from hypothermic mothers have lower body temperature, pH and Apgar scores. It is important to evaluate all women in terms of risk factors in the preoperative period in the prevention of hypothermia and complications related to hypothermia. Prevention of hypothermia, which has negative effects on maternal and newborn health, is one of the risks that the nurse can address independently. Therefore, this research; In order to determine the effect of heating different body areas using compressed air heating technique during cesarean section on hypothermia, tremor, thermal comfort, postpartum comfort and maternal satisfaction, a parallel group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Adult Hospital Gynecology and Obstetrics Department delivery room and obstetrics service. Research data, Introductory Information Form (Appendix 1), Obstetric and Postpartum Features Form (Appendix 2), Patient Monitoring Form (Appendix 3), Termal Comfort Perception Scale (Appendix 4), Shivering Level Diagnostic Form (Appendix 5), LATCH Breastfeeding The Diagnostic and Measurement Tool (Appendix 6) will be collected using the Visual Analogue Scale (Appendix 7) and the Thermal Comfort Scale that will be developed by the researchers. Pregnant women who meet the inclusion criteria will be included in the research. Women will be divided into 4 groups as the lower extremities are heated, the upper extremities are heated, the whole body is heated, and the control group. According to the group of women; It will be heated 30 minutes before surgery and 30 minutes after surgery with lower limb, upper limb or whole body. Women in the control group will not be heated.

NCT ID: NCT04283877 Active, not recruiting - Hypothermia Clinical Trials

The Role of Methylphenidate on Performance in the Cold

Start date: December 15, 2019
Phase: Phase 4
Study type: Interventional

The purpose is to study the effects of dopamine activity, using methylphenidate ingestion, on exercise and cognitive function over the course of a progressive cooling protocol. The investigators hypothesize that methylphenidate will minimize the previously reported impairment in exercise performance and cognitive function with mild hypothermia and cold stress (air temperature: 0˚C) compared to placebo, suggesting that dopamine activity preserves exercise and cognitive capacity with mild hypothermia.

NCT ID: NCT04011462 Active, not recruiting - Hypothermia Clinical Trials

Perioperative Normothermia: Temperature and Prewarming Methods

Normothermia
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).

NCT ID: NCT03890211 Active, not recruiting - Clinical trials for Hypothermia Neonatal

Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo Mother Care (KMC) is a safe and effective method of warming; however, it is not always feasible, for example in settings such as resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not reliable in settings without stable electricity. After two encouraging pilot studies totaling 204 uses in 2 district hospitals and 4 health centers in rural Rwanda, the investigators aim to further study the warmer in a stepped wedge prospective controlled trial in hospital setting to assess safety and efficacy of the Infant Warmer based on clinical observation and feasibility based on observer audits.

NCT ID: NCT03581721 Active, not recruiting - Clinical trials for Postoperative Hypothermia

Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming

CESAR-RESOL2
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Maternal hypothermia is very frequent after caesarean delivery under spinal anaesthesia and should be prevented, as it induces discomfort and increases the risk of postoperative complications. Several modalities of active warming have been explored, with contrasting results. Small IV Fluid warming systems offer effective and safe IV fluid warming without discomfort, and are very easy to use. The investigators hypothesize that such devices can efficiently prevent hypothermia after caesarean section even with high flow rates of infusion. The purpose of this study is to determine whether active fluid warming reduces the occurrence of maternal hypothermia after scheduled caesarean section, as compared with no active warming. The investigators plane to conduce a double-blinded randomized controlled trial. Seventy women undergoing scheduled caesarean section under spinal anaesthesia in 3 different maternity units will be included. The primary outcome is the occurrence of maternal hypothermia (<36.0°C) on admission to the post anaesthesia care unit. The secondary outcomes are perioperative maternal hypothermia, maternal thermal discomfort, maternal recovery and neonatal well-being

NCT ID: NCT03409770 Active, not recruiting - Clinical trials for Neonatal Encephalopathy

Optimising the Duration of Cooling in Mild Encephalopathy

COMET
Start date: October 10, 2019
Phase: N/A
Study type: Interventional

Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.

NCT ID: NCT03345706 Active, not recruiting - Clinical trials for Out-Of-Hospital Cardiac Arrest

Selective Cerebral Hypothermia Trial - Under Extracorporeal Cardiopulmonary Resuscitation (SHOT-ECPR)

Start date: October 11, 2017
Phase: N/A
Study type: Interventional

The study is designed as a pilot, open-label study to investigate the feasibility and safety of selective cerebral hypothermia in OHCA patients receiving ECPR.