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Hypothermia clinical trials

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NCT ID: NCT05680246 Recruiting - Clinical trials for Liver Transplantation

Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)

DHOPEPROLONG
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.

NCT ID: NCT05574855 Recruiting - Perinatal Asphyxia Clinical Trials

Evaluation of Haemodynamic in Neonates Treated With Hypothermia"

Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in developing countries at 25 of 1000 neonates. Despite developments in medicine, increasing understanding of HIE pathophysiology and progress in neonatal intensive care as well as treatment of moderate or severe perinatal asphyxia, HIE continues to be associated with significant mortality and late neurological sequelae. Episodes of ischaemia-hypoxia in the perinatal period as well as the changes in the redistribution of blood may lead to decreased perfusion and ischaemia of the cardiac muscle. Additionally, there is a negative impact from the reduced contractility of the cardiac muscle secondary to acidosis and hypoxia. Therapeutic hypothermia (TH) improves the late effects in moderate and severe cases of hypoxia-ischaemia encephalopathy (HIE). The direct impact of TH on the cardiovascular system includes moderate bradycardia, increased pulmonary vascular resistance (PVR), inferior filling of the left ventricle (LV) and LV stroke volume. The above-mentioned consequences of TH and episodes of HI in the perinatal period are therefore exacerbation of respiratory and circulatory failure. The impact of the warming phase on the cardiovascular system is not well researched and currently few data has been published on this topic. Physiologically, warming increases heart rate, improves cardiac output and increases systemic pressure. The effect of TH and the warming phase on the cardiovascular values has a decisive impact on the metabolism of drugs, including vasopressors / inotropics, which in turn affects the choice of medication and fluid therapy

NCT ID: NCT05409937 Recruiting - Clinical trials for Low Body Temperatures

Influence of Wet Clothing on Thermal Protection

Start date: September 2, 2021
Phase: N/A
Study type: Interventional

The aim of this investigation is to provide guidance for assessing the influence of wet clothing, and its drying time, on body temperature responses during cold air exposure. Twelve healthy and fit adults (men and women aged 18-49) will complete this study. Four cold air exposures (41°F, 180 min) will be randomly conducted, each while wearing a different clothing ensemble that has been saturated by water. During each cold air exposure, you will be asked to rest for 60 min and perform weighted (38.5lbs) treadmill walking for up to 120 min.

NCT ID: NCT05376267 Recruiting - Clinical trials for Hypoxia-Ischemia, Brain

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Start date: August 5, 2022
Phase: N/A
Study type: Interventional

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.

NCT ID: NCT05349734 Recruiting - Clinical trials for Hypothermia; Anesthesia

Comparison of Underbody and Overbody Forced Air Blanket in Pediatric Patients Undergoing Cardiovascular Interventions

Start date: May 12, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.

NCT ID: NCT05333120 Recruiting - Clinical trials for Perioperative Hypothermia

Multi-center Validation of a Hypothermia Prediction Mobile Application (APP)

Start date: May 25, 2021
Phase:
Study type: Observational [Patient Registry]

There have been no fully validated tools for rapid screen of surgical patients at risk of intraoperative hypothermia. The aim of this study is to validate the performance of a previously established prediction model in estimating risk of intraoperative hypothermia using a prospective cohort before further implementation of the model. We hypothesize that the prediction model has helpful discrimination and adequate calibration [1] for clinical use.

NCT ID: NCT05269823 Recruiting - Clinical trials for Injection Site Irritation

Topical Ice-therapy for Intravitreal Injections

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.

NCT ID: NCT05170633 Recruiting - Preterm Birth Clinical Trials

Blood Warming in Preterm Infants to Decrease Hypothermia

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion. Researchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (<36.5°C) in very preterm infants during PRBC transfusions. Process: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit. Outcomes: Very preterm infants (<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures <36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care. Hypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide.

NCT ID: NCT05138172 Recruiting - Clinical trials for Temperature Management During Sedation for Endoscopic Retrograde Cholangiography

Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography

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

The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC).

NCT ID: NCT05127070 Recruiting - Prematurity Clinical Trials

Evaluating the NeoTree in Malawi and Zimbabwe

Start date: October 1, 2019
Phase:
Study type: Observational

Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings. Specific study objectives are as follows: 1. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe 2. To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice. 3. To collect outcome data for newborns from representative sites where NeoTree is not implemented. 4. To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses. 5. To add dashboards and data linkage to the functionality of the NeoTree 6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree 7. To initiate a multi-country network of newborn health care workers, policy makers and academics. 8. To estimate cost of implementing NeoTree at all sites and potential costs at scale