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Hypothermia clinical trials

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NCT ID: NCT04923971 Completed - Hypothermia Clinical Trials

Safety and Performance Monitoring During Occupational Work II

COBRAII
Start date: May 28, 2021
Phase: N/A
Study type: Interventional

BHSAI is developing a computational system that provides early alerts of a rise and fall in core body temperature to help reduce the risk of thermal injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and cold. Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest and exercise in different cold environments. Multiple cold ambient temperatures will be validated.

NCT ID: NCT04867993 Recruiting - Asphyxia Neonatorum Clinical Trials

Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia

Amicool
Start date: August 28, 2018
Phase: N/A
Study type: Interventional

As a part of a project on perinatal clinical pharmacology, the primary aim of the present project is to study amikacin pharmacokinetics (PK) and physiology in asphyxiated neonates treated with therapeutic hypothermia and to provide amikacin dosing recommendations, which will be validated prospectively. For this purpose, we aim to first collect retrospective data on amikacin available in neonates treated with hypothermia in the neonatal intensive care unit (NICU)s in Leuven and Amsterdam, and consequently to propose the dosing regimen to be used in the prospective amikacin PK study at our NICU in University Clinical Center (UCC) Sarajevo. At our NICU we aim to collect amikacin PK observations and other covariates in at least 40 neonates while treated with hypothermia and after re-warming period (a paired analysis), and in asphyxiated neonates not treated with hypothermia (control group). We hereby will use a stepwise approach, as initially used to develop and to validate an amikacin dosing regimen in preterm and term neonates (De Cock RFW et al., 2012, Smits A et al, 2015). A 3-step approach will be used, of which different parts will be conducted in different contributing hospitals: 1. Retrospective evaluation of amikacin therapeutic drug monitoring (TDM) in asphyxiated neonates treated with hypothermia (University hospital Leuven, VUmc Amsterdam) 2. Development of population PK model derived amikacin dosing recommendation 3. Prospective PK study with validation of the new dosing regimen (UCC Sarajevo, UCC Tuzla)

NCT ID: NCT04827394 Completed - Hypothermia Clinical Trials

Neonatal Warming to Prevent Hypothermia

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of c-section in babies born between 32 and 36 weeks to determine if it reduces the risk of hypothermia.

NCT ID: NCT04825418 Not yet recruiting - Hypothermia Clinical Trials

Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

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

To study safety and feasibility of mild therapeutic hypothermia after decompressive hemicraniectomy compared with hemicraniectomy alone in patients with malignant cerebral infarction

NCT ID: NCT04817280 Completed - Covid19 Clinical Trials

COVID-19 in Polish Ice Swimmers.

ICE
Start date: December 1, 2020
Phase:
Study type: Observational

Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. In the face of the current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic causing Coronavirus Disease 2019 (COVID-19), researchers decided to use a survey to check the incidence of COVID-19 among Polish ice swimmers, as well as recent ailments. Then, the researchers will compare the obtained results with epidemiological data for Poland.Researchers will also investigate the relationship between susceptibility to SARS-CoV-2 infection and the blood group and Rh factor among ice swimmers.

NCT ID: NCT04761484 Recruiting - Clinical trials for Preterm Birth Complication

Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU

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

Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission. The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

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: NCT04744389 Recruiting - Clinical trials for End Stage Liver DIsease

Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.

DCDNet
Start date: December 15, 2020
Phase: N/A
Study type: Interventional

Study groups: The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors). Once a DCD or a DBD with extended criteria (ECD-DBD) meets the inclusion criteria, they are randomized as follow: 1. 20 liver grafts from DCD after normothermic regional perfusion (NRP) matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted. 2. 40 liver grafts from ECD-DBD matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted

NCT ID: NCT04741815 Completed - Clinical trials for Inadvertent Perioperative Hypothermia

Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

Start date: January 22, 2019
Phase: N/A
Study type: Interventional

Cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. However, even surgery alone is an 80% important cause of hypothermia. Inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. In most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. Despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. In the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.

NCT ID: NCT04709627 Completed - Clinical trials for Hypothermia; Anesthesia

enFlow IV Fluid and Blood Warming System

Start date: July 6, 2021
Phase:
Study type: Observational

This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.