Efficacy of a Novel Intraoral Cooling Device (2024)

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Cancer Chemotherapy and Pharmacology

Innovative intraoral cooling device better tolerated and equally effective as ice cooling

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Therapeutic Hypothermia and Temperature Management

Efficacy and Safety of Transnasal CoolStat Cooling Device to Induce and Maintain Hypothermia

2019 •

Aravindan Kolandaivelu

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Journal of Medical Devices

A Head and Neck Support Device for Inducing Local Hypothermia

2013 •

Paul Iaizzo

The present work describes the design of a device/system intended to induce local mild hypothermia by simultaneously cooling a patient's head and neck. The therapeutic goal is to lower the head and neck temperatures to 33–35 °C, while leaving the core body temperature unchanged. The device works by circulating a cold fluid around the exterior of the head and neck. The head surface area is separated into five different cooling zones. Each zone has a cooling coil and can be independently controlled. The cooling coils are tightly wrapped concentric circles of tubing. This design allows for a dense packing of tubes in a limited space, while preventing crimping of the tubing and minimizing the fluid pressure head loss. The design in the neck region also has multiple tubes wrapping around the circumference of the patient's neck in a helix. Preliminary testing indicates that this approach is capable of achieving the design goal of cooling the brain tissue (at a depth of 2.5 cm from...

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Local Brain Temperature Reduction Through Intranasal Cooling With the RhinoChill Device: Preliminary Safety Data in Brain-Injured Patients

2011 •

Denise Barbut

Background and Purpose— Hypothermia is neuroprotectant but currently available cooling methods are laborious, invasive, and require whole-body cooling. There is a need for less invasive cooling of the brain. This study was conducted to assess the safety and efficacy of temperature reduction of the RhinoChill transnasal cooling device. Methods— We conducted a prospective single-arm safety and feasibility study of intubated patients for whom temperature reduction was indicated. After rhinoscopy, the device was activated for 1 hour. Brain, tympanic, and core temperatures along with vital signs and laboratory studies were recorded. All general and device-related adverse events were collected for the entire hypothermia treatment. Results— A total of 15 patients (mean age, 50.3±17.1 years) were enrolled. Brain injury was caused by intracerebral hemorrhage, trauma, and ischemic stroke in equal numbers. Hypothermia was induced for fever control in 9 patients and for neuroprotection/intracra...

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Journal of Neurosurgical Anesthesiology

Effectiveness of an Intravascular Cooling Method Compared With a Conventional Cooling Technique in Neurologic Patients

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Onnen Moerer

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Medical Oncology

Randomized cross-over study investigating the tolerability and side effects of an intra-oral air-cooling device compared to ice in healthy volunteers

Peter Frykholm

Oral cryotherapy (OC) is a common preventive treatment of oral mucositis (OM) and is recommended in international guidelines. Ice and air OC have previously been shown to result in temperature reductions of 8.1–12.9 °C, and 14.5 °C, respectively, in healthy volunteers. However, no direct comparison between these two modalities has been performed. The primary aim was to investigate the tolerability and side effects of air OC using an intra-oral air-cooling (IOAC) device compared with ice OC. The secondary aim was to evaluate the temperature reduction in the mouth for the two respective methods. Cross-over study with randomization to order of treatment, in 15 healthy volunteers. We evaluated the self-reported intensity, frequency, and discomfort for 13 pre-defined side effects used in previous studies. All participants were able to complete both OC sessions, although one participant required reduced airflow in the air OC arm. The subjects reported more discomfort from being cold, havi...

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Circulation

Intra-Arrest Transnasal Evaporative Cooling: A Randomized, Prehospital, Multicenter Study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness)

2010 •

A. Pesenti

Background— Transnasal evaporative cooling has sufficient heat transfer capacity for effective intra-arrest cooling and improves survival in swine. The aim of this study was to determine the safety, feasibility, and cooling efficacy of prehospital transnasal cooling in humans and to explore its effects on neurologically intact survival to hospital discharge. Methods and Results— Witnessed cardiac arrest patients with a treatment interval ≤20 minutes were randomized to intra-arrest cooling with a RhinoChill device (treatment group, n=96) versus standard care (control group, n=104). The final analysis included 93 versus 101 patients, respectively. Both groups were cooled after hospital arrival. The patients had similar demographics, initial rhythms, rates of bystander cardiopulmonary resuscitation, and intervals to cardiopulmonary resuscitation and arrival of advanced life support personnel. Eighteen device-related adverse events (1 periorbital emphysema, 3 epistaxis, 1 perioral bleed...

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International Journal of Heat and Mass Transfer

Targeted brain hypothermia induced by an interstitial cooling device in the rat neck: Experimental study and model validation

2008 •

Yunjian Wang

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Anesthesia & Analgesia

Rapid Core-to-Peripheral Tissue Heat Transfer During Cutaneous Cooling

1996 •

Daniel Sessler

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Efficacy of a Novel Intraoral Cooling Device (2024)
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