Hypothermia

9

Review clinical trials related to Hypothermia. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon

This research was planned to determine the effect of acupressure on hypothermia and shivering after cesarean section. H01: There is no difference in hypothermia findings between women who received acupressure and women in the control group. H02: There is no difference in shivering findings between women who received acupressure and women in the control group. Women who present to the hospital for cesarean delivery and who meet the inclusion criteria and volunteer to participate in the study will be informed, and their verbal and written consent will be obtained. Before the acupressure application, the women will be interviewed face-to-face, and a pregnancy information form will be recorded by the researcher. Subsequently, a vital signs monitoring form, a temperature comfort perception scale, and a shivering level assessment form will be completed. Acupressure group: Half an hour prior to cesarean delivery, pressure was applied to the Yong Quan point (Kd1), the Chongyang point (ST42) on both feet, and the Zu San Li point (ST36) located under the patella. The application involved applying pressure to both feet simultaneously, first to ST42 and Kd1, then to ST36, for 3 minutes each time using the index finger, followed by a 3-minute rest period. This was repeated three times. Control group: Women who underwent cesarean section received routine postpartum care procedures.

Participants needed: 57
Trial details
Age: 18-35Biological sex: FemaleType: InterventionalSponsor: Ondokuz Mayıs UniversityUpdated: Oct 7, 2026Locations: 1
Eligibility criteria

who underwent elective cesarean section, [+5]

Women diagnosed with high-risk pregnancies, [+7]

Status: Not yet recruiting

Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries

Shivering is a common and distressing complication following spinal anesthesia, affecting up to 70% of patients. It significantly increases oxygen consumption, places stress on the cardiovascular system, and interferes with postoperative monitoring. While intravenous paracetamol has been shown to reduce post-spinal shivering without the sedation or respiratory side effects associated with other medications, existing trials have only investigated a standard 1-gram dose. This study aims to evaluate whether a higher dose of intravenous paracetamol (2 grams) provides superior prevention of post-spinal shivering compared to the standard 1-gram dose and an inactive placebo. Adult patients scheduled for elective lower-limb orthopedic surgery under spinal anesthesia will be randomly allocated to one of three study groups: * High-dose group: intravenous paracetamol 2 g * Standard-dose group: intravenous paracetamol 1 g * Control group: intravenous normal saline placebo Each infusion will be administered over 15 minutes immediately prior to spinal anesthesia. Participants will be observed intraoperatively and for at least 60 minutes in the post-anesthesia care unit (PACU) to measure the incidence and severity of shivering, core body temperature changes, the need for rescue medication, and any adverse events.

Participants needed: 150
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Oct 2, 2026
Eligibility criteria

Age 18 to 65 years [+4]

Patient refusal or inability to provide informed consent [+11]

Status: Not yet recruiting

Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia

Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical monitoring. While intravenous meperidine remains a widely used pharmacological agent for shivering prophylaxis, it carries dose-dependent adverse effects such as nausea, vomiting, sedation, and potential neonatal depression. Intranasal dexmedetomidine provides an alternative needle-free method of administration that rapidly absorbs through the nasal mucosa and reduces shivering without suppressing respiratory drive. The primary purpose of this randomized controlled trial is to evaluate the efficacy of preoperative intranasal dexmedetomidine in reducing the incidence of intraoperative shivering compared with intravenous meperidine and placebo in women undergoing elective cesarean section under spinal anesthesia. A total of 99 parturients will be randomly allocated to one of three parallel groups (33 patients per group) using a double-dummy design: * Group D: Receives intranasal dexmedetomidine (1 mcg/kg) 30 minutes before spinal anesthesia, plus an intravenous saline placebo at spinal induction. * Group M: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous meperidine (0.5 mg/kg) at spinal induction. * Group C: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous saline placebo at spinal induction. Participants will be monitored throughout the surgical procedure to determine the occurrence of shivering, maternal hemodynamic parameters (heart rate, blood pressure, oxygen saturation), sedation levels using the Richmond Agitation-Sedation Scale (RASS), need for rescue anti-shivering medication, side effects, and neonatal outcomes (Apgar scores and birth weight).

Participants needed: 99
Trial details
Phase: Phase 4Age: 18-40Biological sex: FemaleType: InterventionalSponsor: Assiut UniversityUpdated: Oct 2, 2026
Eligibility criteria

Female patients aged 18 to 40 years. [+3]

Refusal to participate. [+8]

Status: Not yet recruiting

Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section

Spinal anesthesia is the preferred anesthetic method for elective cesarean deliveries, but it frequently causes post-spinal shivering. Shivering causes marked maternal discomfort, interferes with clinical monitoring, and increases oxygen consumption and metabolic workload. This study aims to assess whether a prophylactic intravenous combination of low-dose midazolam and low-dose ketamine reduces the occurrence and severity of shivering compared with a placebo in women undergoing elective cesarean delivery under spinal anesthesia. A total of 120 parturients will be randomly assigned into two equal groups: * Combination Group: Receives intravenous midazolam (0.0375 mg/kg) combined with ketamine (0.25 mg/kg) diluted in 20 mL of 0.9% normal saline. * Control Group: Receives 20 mL of 0.9% normal saline intravenously as a placebo. In both groups, the intravenous infusion is administered over 10 minutes immediately following delivery of the infant and clamping of the umbilical cord, ensuring no transplacental transfer of the study medications to the newborn. The primary objective is to evaluate the proportion of patients who develop shivering during the first 60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary objectives include shivering severity, the requirement for rescue anti-shivering medication, intraoperative and postoperative sedation levels, hemodynamic stability, body temperature course, potential medication side effects, and maternal satisfaction.

Participants needed: 120
Trial details
Phase: Phase 4Age: 18-40Biological sex: FemaleType: InterventionalSponsor: Assiut UniversityUpdated: Oct 2, 2026
Eligibility criteria

Pregnant women aged 18 to 40 years old. [+4]

Patient refusal. [+8]

Status: Recruiting

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).

Participants needed: 1,022
Trial details
Age: 18-79Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Sep 16, 2026Locations: 17
Eligibility criteria

Adult out-of-hospital cardiac arrest patients with initial shockable rhythm [+2]

Age ≥ 80 years [+6]

Status: Recruiting

ESOTIP-TEE: Defining an Easy Landmark to Guide Correct Esophageal Probe Placement With Transesophageal Echocardiography

This prospective observational study aims to identify simple external anatomical landmarks that allow reliable prediction of correct esophageal probe insertion depth. Accurate placement in the lower third of the esophagus is essential for reliable core temperature monitoring. Transesophageal echocardiography (TEE) will be used as the reference standard to confirm correct probe position. The study will evaluate the agreement between landmark-based insertion depth and TEE-confirmed placement in adult ICU patients undergoing clinically indicated TEE.

Participants needed: 30
Trial details
Biological sex: AllType: ObservationalSponsor: Institute of Mountain Emergency MedicineUpdated: May 8, 2026Locations: 1
Eligibility criteria

Adult (≥18 years) patients admitted to the ICU [+1]

<18 years

Status: Recruiting

Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection

The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 306 participants diagnosed with acute type A aortic dissection (ATAAD) from 7 hospitals in China. All patients receive total arch replacement (TAR) combined with frozen elephant trunk (FET) implantation and are randomized to Group 1 (arch-clamping technique under mild hypothermia), Group 2 (arch-clamping technique under moderate hypothermia) and Group 3 (Sun's procedure using bilateral antegrade cerebral perfusion) in the ratio of 1:1:1. After a 1-year follow-up, the validity and safety of the mild hypothermic arch-clamping technique for ATAAD was evaluated via the incidence of major adverse events including death, renal replacement therapy, stroke, and paraplegia, as well as times of circulatory arrest, cardiopulmonary bypass, and mechanical ventilation, and length of ICU stay.

Participants needed: 306
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Beijing Anzhen HospitalUpdated: Apr 6, 2026Locations: 1
Eligibility criteria

Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Di... [+4]

History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency; [+11]

Status: Not yet recruiting

The Effect of Warmed Socks Developed as Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering

In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. 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 analysis as further analy

Participants needed: 70
Trial details
Biological sex: AllType: InterventionalSponsor: Tarsus UniversityUpdated: Sep 9, 2025
Eligibility criteria

-Written and verbal permission to participate in the study was obtained, [+8]

Written and verbal permission to participate in the research could not be obtain... [+8]

Status: Recruiting

Blood Warming in Preterm Infants to Decrease Hypothermia

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.

Participants needed: 140
Trial details
Age: 24-32Biological sex: AllType: InterventionalSponsor: University of South CarolinaUpdated: Dec 11, 2024Locations: 1
Eligibility criteria

Any infant born at PRISMA Health Richland hospital [+2]

Infants having neurological anatomical abnormalities or major brain hemorrhage (...