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Hypothermia clinical trials

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NCT ID: NCT06256354 Not yet recruiting - Delirium Clinical Trials

Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival

Start date: April 2024
Phase: N/A
Study type: Interventional

Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor. Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium, which is associated with worse early and long-term outcomes. Furthermore, perioperative hypothermia increases stress responses and provokes immune suppression, which might promote cancer recurrence and metastasis. In a recent trial, targeted temperature management reduced intraoperative hypothermia and emergence delirium. There was also a trend of reduced postoperative delirium, although not statistically significant. This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major cancer surgery.

NCT ID: NCT06250374 Recruiting - Clinical trials for Pulmonary Hypertension

Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery.

HYPO-TEP
Start date: August 24, 2023
Phase: N/A
Study type: Interventional

Cardiopulmonary bypass (CPB) surgery present risk of acute postoperative neurological complications. These complications are most often postoperative cognitive dysfunction (confusion, cognitive disorders, executive disorders) with a prevalence of up to 40% at 5 years, and ischemic (stroke) with an incidence of between 0.4 and 14%. The causes are usually multifactorial, but altered cerebral perfusion during CPB surgery is an important prognostic factor. Data regarding the effect of deep hypothermia on cerebral perfusion during CPB in adult are scarce. Currently, aortic arch replacement following aortic dissection or aneurysm, and pulmonary artery endarterectomy (PAE) in the treatment of pulmonary hypertension of post embolic origin are performed under deep hypothermia. In this latter indication, the need to obtain a completely bloodless operating field necessitates complete circulatory arrest during short period of time to enable the surgeon to optimally remove the clot materials located into the pulmonary arteries. To protect the brain and avoid irreversible brain injury during circulatory arrest(s), body temperature is lowered at 18-20°C. Deep hypothermia can lead to significant arterial vasoconstriction, which can reduce the blood supply to the brai. It also increases the solubility of CO2 in the blood, leading to respiratory alkalosis, which can also lead to vasoconstriction of cerebral vessels, increasing the risk of ischemic lesions. In adult there is no consistent data on the cerebral perfusion during PAE surgery under deep hypothermia at 18-20°C. Animal studies showed that cerebral regulation seems to be preserved under these conditions. A better understanding of the effect of deep hypothermia on cerebral perfusion during PAE surgery is essential to adapt our management to limit the occurrence of postoperative neurological complications.

NCT ID: NCT06245148 Completed - Clinical trials for Ephedrine Usage and Hypothermia Incidence

The Effect of Intraoperative Ephedrine Use on the Incidence of Hypothermia After Major Surgery

Start date: January 2, 2019
Phase:
Study type: Observational [Patient Registry]

Intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. The consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. Therefore, strategies aimed at preventing hypothermia are of paramount importance in modern surgical practice. However, despite all the measures taken, some patients may still become hypothermic at the end of surgery. Understanding these factors can enhance the quality of daily practice. Medications used intraoperatively can decrease the threshold for vasoconstriction, and some of them have been reported to influence thermoregulation. For example, ephedrine is a sympathomimetic amine used to maintain hemodynamic stability, but there is a report about its thermogenic effect. One study found that patients who received an intraoperative infusion of ephedrine had a significantly lower decrease in core temperature and these patients had a more stable hemodynamic profile. It was employed in obese patients for its thermogenic and appetite-suppressing effects until its adverse effects prevented its use. Ephedrine has an unintended yet significant effect on body temperature regulation, which has raised questions about its role in contributing to the incidence of hypothermia in the postoperative period. The purpose of this study is to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery.

NCT ID: NCT06238739 Completed - Postoperative Pain Clinical Trials

Optimal Temperature Control in Body Contouring Procedures

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

The goal of this clinical trial is to compare different strategies for normothermia prevention in patients undergoing body contouring and other Aesthetic Plastic Surgery procedures. The main question(s) it aims to answer are: - Do active measures have an impact on preventing hypothermia in patients undergoing cosmetic procedures? - Does an active normothermia prevention protocol have any impact in the clinical setting? Four different protocols will be used for patient peroperative preparation for normothermia.

NCT ID: NCT06230172 Recruiting - Clinical trials for Body Temperature Changes

Early Weaning From Incubator To Crib

Start date: July 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams. Our hypothesis is that early weaning from the incubator to a crib/bassinet is safe and may result in a decrease in length of hospital stay while maintaining appropriate growth velocity. Specific outcomes the investigators will evaluate are the length of hospital stay and growth velocity at early weaning.

NCT ID: NCT06200285 Recruiting - Clinical trials for Accidental Hypothermia

International Registry of Accidental Hypothermia

IHR
Start date: October 1, 2008
Phase:
Study type: Observational [Patient Registry]

Transient mild hypothermia (core body temperature 35-32°C) is common and usually without consequences for the brain or other organs. However, prolonged severe accidental hypothermia (core body temperature below 28°C) due to accidents is rare, and usually fatal in more than 50% of cases. Little is known on its physiopathology, on prognostic factors for rewarming decision or ideal rewarming techniques for better survival. Furthermore, complications after successful rewarming are extremely frequent and very often severe or fatal. Accidental hypothermia is a frequent problem during the winter months and can be caused by snow sport accidents, near drowning and urban cold exposure. The International Hypothermia Registry's principle goal is to increase knowledge on accidental hypothermia by creating the largest database on accidental hypothermia which will comprise enough patient data to give a statistical power since the causes of accidental hypothermia and its treatment varies greatly. The International Hypothermia Registry (IHR) will enable improvement of pre- and in-hospital treatment and rewarming methods, study survival predictors and prevention of post-rewarming complications. By this way, the IHR will permit the establishment of evidence-based diagnosis and treatment guidelines.

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: NCT06131892 Completed - Clinical trials for Hypothermia, Accidental

Defibrillation in Accidental Hypothermia

Start date: April 1, 2023
Phase:
Study type: Observational

Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature <30°C. Also, below <30°C after successful defibrillation, a perfusing rhythm often degenerates to ventricular fibrillation (VF) again. Repeated defibrillation can induce myocardial injury. Thus, the guidelines of the European Resuscitation Council (ERC) suggest delaying further defibrillation attempts until the core temperature is >30°C if VF persists after 3 shocks. Epinephrine should be withheld if core temperature is <30°C. Advanced Life Support (ALS) guidelines of the American Heart Association (AHA) state that it may be reasonable to perform further defibrillation attempts according to the standard algorithm and to consider administration of a vasopressor during cardiac arrest (Table 1). This discrepancy between ERC and AHA guidelines can be explained by the different interpretations of mainly animal data, which show that vasopressors increase the chances of successful defibrillation <30°C, defined as return of spontaneous circulation (ROSC) for at least 30 seconds. The guidelines of the Wilderness and Environmental Medicine Society (WMS) state that a single shock at a maximum power can be given for patients with a temperature <30°C. The aim of this study is to evaluate clinical course of hypothermic patients(<30°C) undergoing defibrillation. The primary aim is to evaluate the success ratio of defibrillation, defined as ROSC for at least 30 seconds. Secondary aims are the recurrence rate of ventricular fibrillation, the number of defibrillation attempts per patient, the presence of cardiac dysfunction after defibrillation and the cerebral performance category (CPC) score at the end of hospitalization.

NCT ID: NCT06129825 Not yet recruiting - Hypoxia Clinical Trials

Pharmacologic Induction of Tolerance for Hypoxia & Hypothermia

PhITHy-Ho
Start date: December 1, 2024
Phase:
Study type: Observational

Warfighter Performance Optimization in Extreme Environments remains an area of important and intense investigation, with the following goals: (1) Optimize, sustain and augment medical readiness and physiological/ psychological performance in extreme and hazardous military operational environments and (2) develop joint DoD countermeasures and guidance to sustain performance, assess physiological status, and reduce injury risk in extreme and hazardous operational environments. Successful and safe outcomes in extreme and hazardous operational environments require that warfighters maintain optimum cognitive and exercise performance during physiologic stress. Extreme environmental conditions encountered in such environments include warfighter exposure to hypoxia and hypothermia, alone or in combination. Both hypoxia and hypothermia undermine O2 delivery system homeostasis, imposing dangerous constraints upon warfighter cognitive and exercise capacity. While red blood cells (RBCs) are commonly recognized as O2 transport agents, their function as a key signaling and control node in O2 system delivery homeostasis is newly appreciated. Through O2 content-responsive modulation of RBC energetics, biomechanics, O2 affinity and control of vasoactive effectors in plasma - RBCs coordinate stabilizing responses of the lung, heart, vascular tree and autonomic nervous system - in a fashion that maintains O2 delivery system homeostasis in the setting of either reduced O2 availability (hypobaric hypoxia) or increased O2 demand (hypothermia). Human RBCs demonstrate adaptive responses to exercise, hypoxia and hypothermia - these changes are commonly appreciated as a key element enabling high altitude adaptation. However, under conditions of hypoxia and hypothermia, without prior adaptation, RBC performance is adversely impacted and limits the dynamic range of stress adaptation for O2 delivery homeostasis - therefore limiting warfighter exercise capacity and cognitive performance in extreme environments, such as during acute mountain sickness.

NCT ID: NCT06109376 Not yet recruiting - Clinical trials for Stroke, Acute Ischemic

Role of Hypothermia in Endovascular Stroke Thrombectomy

COOLING
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach. In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear. The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.