Treatment Trials

11 Clinical Trials for Various Conditions

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COMPLETED
Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
Description

Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining Normothermia During the Peri-operative Period

Conditions
COMPLETED
Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Description

Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.

UNKNOWN
Normothermia Protocol for Traumatic Brain Injury Patients
Description

Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU) 2. Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)

RECRUITING
Transnasal Induction of Normothermia for Neurogenic Fever
Description

The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

COMPLETED
Transnasal Induction of Normothermia in Febrile Stroke Patients
Description

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

COMPLETED
Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest
Description

ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.

COMPLETED
Thermal Compression Device for Maintenance of Perioperative Normothermia
Description

Getting cold (not maintaining normothermia) around surgery (perioperative period) leads to many negative outcomes for patients including increased wound complications, abnormal heart rhythms and increased blood loss. These all lead to increased length of hospital stay and higher requirements for post operative monitoring. These add to around $3500 of extra costs per patient. The investigators aim to study the effects of a warming device, placed around the patient's legs and/or feet, to determine it's safety, efficacy and eventually compare to the current gold standard of a forced air warming blanket. Forced air warming has been associated with the spread of germs over the surgical field. Hence the need for warming equipment that won't do that.

Conditions
COMPLETED
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Description

When fever is present in patients with stroke, traumatic brain injury (TBI), or brain hemorrhage, it has been associated with worse outcomes including larger areas of tissue death, increased length of stay, worse degree of coma, lower ability to function, and higher mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal body temperature should be a standard of care. However, no further standards or options are presented to specifically guide practice. The current ischemic stroke guidelines state that fever should be treated with fever-reducing agents and offer "cooling devices" as an option but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of their stay. With elevated temperatures the body consumes more oxygen than if the temperature was normal, causing less oxygen to be available to the brain. This may lead to injury of the brain cells and a diminished capacity for healing. Thus, temperature management in neurologically vulnerable patients is both a prevalent and problematic challenge. Based on this information the goal of the present proposal is to evaluate if 1) A standardized, step-wise approach to temperature management using a Normothermia Protocol is successful in achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If maintenance of normal temperature will be associated with fewer episodes of diminished responsiveness in their neurological exams as evidenced by a measure of depth of coma, as measured by the Glasgow Coma Score (GCS) compared to a control group treated according to usual care.

NOT_YET_RECRUITING
Intraoperative Warming: Comparison of Two Temperature Management Systems
Description

The goal of this clinical trial is to compare two temperature management systems, the warmUP (WU-20) and the Bair Hugger®, in preventing perioperative hypothermia during surgeries. The study aims to determine whether the warmUP system is as effective as the Bair Hugger® in maintaining core body temperature. The main questions this trial aims to answer are: Does the warmUP system maintain intraoperative body temperatures as effectively as the Bair Hugger® during abdominal surgeries? Does the warmUP system offer additional benefits, such as reduced bacterial dispersion compared to the Bair Hugger®? Participants will: Use either the warmUP or Bair Hugger® system during surgery Undergo abdominal surgeries lasting approximately 2.5 hours Have their core temperatures monitored to assess the effectiveness of the warming device The study will evaluate whether the warmUP system provides equivalent temperature management with a smaller body surface area exposed, potentially offering advantages in surgical infection control.

TERMINATED
Perioperative Active Warming Techniques in Colorectal Surgeries
Description

We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.

Conditions
UNKNOWN
Safety and Feasibility Study of Targeted Temperature Management After ICH
Description

Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis for future larger clinical trials.