Hypothermia Clinical Trial
Official title:
WarmSmart Warming Protocol
NCT number | NCT02812069 |
Other study ID # | 15-942 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | July 17, 2017 |
Verified date | October 2018 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypothermia during surgery and in the postoperative period is associated with adverse
outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune
function, coagulopathy, and increased use of hospital resources. Several clinical studies
have demonstrated that maintenance of normothermia during the perioperative period
significantly reduces morbidity.
Mercury Biomed has developed a patient-warming system, WarmSmart, that potentially transfers
adequate heat through hands and feet based on the physiological principle of peripheral
arterio-venous shunt vaso-dilation. The technology works as a two-step process by selective
thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts
and triggering arterio-venous shunt vasodilation and by applying circulating water heat
exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that
area.
General anesthesia reduces the vasoconstriction threshold (triggering core temperature) by
1-2°C, thus promoting arteriovenous shunt dilation. It remains unknown, though, whether
cervical spine warming further augments arterio-venous shunt dilation during general
anesthesia. If spine heating proves unnecessary under anesthesia, Mercury Biomed's WarmSmart
warming could be simpler and less expensive. Investigators therefore propose to test the
hypothesis that cutaneous heating near the cervical spine does not further augment
arterio-venous flow in fingers during general anesthesia.
Investigators propose to enroll ten patients. The patients will be pre-warmed and warmed
intraoperatively with forced-air to maintain a core temperature near 36°C.
A ThermaZone® Device capable of heating the cervical spine area will be positioned behind the
patient's neck upon arrival in the operating rooms. Additionally a forced-air warmer will be
positioned appropriately and activated as soon as practical, usually after prepping and
draping. Ambient temperature will be maintained near 20°C.
After about one hour of anesthesia when temperature and other factors are stable,
investigators will start a 30-minute observation period. Thereafter investigators will
activate the cervical spine warming system for 30 minutes (warming measurement period) and
thereafter have a 30 minutes control period again.
Measurements will be recorded such as mean-skin temperature, distal esophageal temperature,
MAC fraction, mean-arterial pressure and finger blood flow.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 17, 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Body-mass index 20-33 kg/m2; 2. Age 18-70 yrs; 3. ASA Physical Status 1-3. Exclusion Criteria: 1. Serious skin lesions on the hands or arms; 2. History of serious vascular disease in the arms, including Raynaud's Syndrome; 3. Pre-operative fever or infection; 4. Surgery expected to be supine and in neutral position. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | volume plethysmography | Recorded from the time the ThermaZone® Device is placed for 30 minutes to thirty minutes after it's removal at 10-minute intervals from the beginning of the initial observation period until the end of the post-warming recovery period. | ||
Primary | mean-skin temperature | Recorded from the time the ThermaZone® Device is placed for 30 minutes to thirty minutes after it's removal at 10-minute intervals from the beginning of the initial observation period until the end of the post-warming recovery period. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Not yet recruiting |
NCT05306392 -
Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation
|
N/A | |
Completed |
NCT02685176 -
Head and Torso Rewarming Using a Human Model for Severe Hypothermia
|
N/A | |
Completed |
NCT02586974 -
Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
|
N/A | |
Not yet recruiting |
NCT02211703 -
National Epidemiologic Survey on the Incidence of Perioperative Hypothermia
|
N/A | |
Completed |
NCT02177903 -
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
|
N/A | |
Completed |
NCT02742818 -
Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
|
N/A | |
Completed |
NCT02121574 -
Accuracy of Zero-flux and Ingestible Thermometers
|
N/A | |
Recruiting |
NCT01866384 -
Targeted Temperature Management After Intracerebral Hemorrhage
|
Phase 2 | |
Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
Completed |
NCT01793337 -
Core Body Temperature Measurement During Hot and Cold Environmental Exposure
|
N/A | |
Completed |
NCT01722955 -
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
|
N/A | |
Completed |
NCT01559675 -
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
|
N/A | |
Terminated |
NCT01018576 -
Delayed Cord Clamping in Premature Infants
|
N/A | |
Completed |
NCT00904228 -
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
|
N/A | |
Terminated |
NCT00822796 -
Thermogard™ Efficacy Trial
|
N/A | |
Completed |
NCT00334360 -
Dexmed/Buspirone Synergism on Shivering
|
Phase 4 | |
Not yet recruiting |
NCT06283771 -
The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering
|
N/A | |
Completed |
NCT04399902 -
Study to Actively Warm Trauma Patients
|
N/A | |
Completed |
NCT03450668 -
mOm Incubator Pilot Study
|
N/A |