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Hypothermia clinical trials

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NCT ID: NCT05887518 Withdrawn - Clinical trials for Venous Thromboembolism

The Effect of Sock Developed With Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism

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

The aim of this study is to examine the effect of the sock to be developed with wearable technology for patients who will undergo TUR surgery on the development of hypothermia and VTE. The population of the study will consist of patients who will undergo TUR surgery between 01 October 2023 and 01 October 2024. patients will be included in the study. The study was planned as a prospective, two-arm (1:1), randomised controlled, double-blind clinical trial. The data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form". The hypothermia follow-up form includes "Shivering Level Diagnosis Form" and "Temperature Comfort Perception Scale" The descriptive variables of the patients included in the study will be expressed as mean ± standard deviation and median (maximum-minimum), percentage and frequency. In data analysis; dependent and independent t test will be used when parametric test preconditions are met. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analyses as further analysis. Post hoc power analysis will be performed after the sample size reaches 70.

NCT ID: NCT05581927 Withdrawn - Brain Injury Clinical Trials

Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)

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

Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

NCT ID: NCT05295784 Withdrawn - Acute Kidney Injury Clinical Trials

PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia

Start date: May 8, 2024
Phase: Phase 1
Study type: Interventional

A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.

NCT ID: NCT04570462 Withdrawn - COVID19 ARDS Clinical Trials

Mild Hypothermia for COVID-19 ARDS

Start date: May 18, 2020
Phase: N/A
Study type: Interventional

Some patients with COVID have abnormally high carbon dioxide and low oxygen levels despite being on the ventilator. The hypothesis of the study is that the application of mild hypothermia to patients with COVID will decrease their metabolic rate and improve their oxygenation and carbon dioxide levels.

NCT ID: NCT03376854 Withdrawn - Sars-CoV2 Clinical Trials

Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS

CHILL-pilot
Start date: May 1, 2018
Phase: Phase 2
Study type: Interventional

Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the investigators sought to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. The investigators are scheduled to begin enrolling in a Department of Defense-funded Phase IIb multicenter RCT of TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients with ARDS with time on ventilator as the primary outcome. Since COVID-19 is now the most common cause of ARDS, we are conducting a pilot study to examine the safety and feasibility of including patients with COVID-19-associated ARDS in our upcoming trial. In this pilot, we will randomize 20 patients with COVID-19 and ARDS to either TH+NMBA for 48h or usual temperature management. The primary outcome is achieving and maintaining the target temperature. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected on days 0, 1, 2, 3, 4, and 7.

NCT ID: NCT03351036 Withdrawn - Hypothermia Clinical Trials

Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?

Start date: April 2015
Phase: N/A
Study type: Observational

Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia concerning it´s implementation in the clinical routine.

NCT ID: NCT03344991 Withdrawn - Infant, Premature Clinical Trials

Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

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

Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.

NCT ID: NCT03344978 Withdrawn - Infant, Premature Clinical Trials

Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial

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

This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.

NCT ID: NCT03313258 Withdrawn - Trauma Clinical Trials

Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)

RUZIT
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.

NCT ID: NCT03141736 Withdrawn - Preterm Birth Clinical Trials

Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

Start date: November 19, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.