Hypothermia Clinical Trial
Official title:
Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure
NCT number | NCT01793337 |
Other study ID # | V/31/10 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | February 13, 2013 |
Last updated | February 14, 2013 |
Start date | September 2012 |
Verified date | February 2013 |
Source | Institute of Mountain Emergency Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the Double Sensor device is a non-invasive device and is promising for prehospital use but has not been sufficiently verified under very cold and hot environmental conditions. Furthermore, comparisons of different non-invasive methods with oesophageal measurement in extreme conditions are lacking. The objective of these studies is to compare different techniques of core body temperature measurement with exposure to cold and hot environments.
Status | Completed |
Enrollment | 32 |
Est. completion date | |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 years old - ASA class 1 Exclusion Criteria: - <18 years old - American society of anesthesiologists class >1 - history of ear, nose, throat surgery - congenital malformation of head/throat/ear/nose - absence of informed consent |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | Eurac research | Bolzano | Provincia autonoma di Bolzano |
Lead Sponsor | Collaborator |
---|---|
Institute of Mountain Emergency Medicine | Medical University Innsbruck |
Italy,
Gunga HC, Werner A, Stahn A, Steinach M, Schlabs T, Koralewski E, Kunz D, Belavý DL, Felsenberg D, Sattler F, Koch J. The Double Sensor-A non-invasive device to continuously monitor core temperature in humans on earth and in space. Respir Physiol Neurobiol. 2009 Oct;169 Suppl 1:S63-8. doi: 10.1016/j.resp.2009.04.005. Epub 2009 Apr 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between oesophageal and epitympanic temperature | 10 min measurment at +20 °C followed by 10 min measurment at -20 °C | No |
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 | |
Withdrawn |
NCT02812069 -
WarmSmart Warming Protocol
|
N/A | |
Completed |
NCT02121574 -
Accuracy of Zero-flux and Ingestible Thermometers
|
N/A | |
Completed |
NCT02742818 -
Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
|
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 | |
Recruiting |
NCT01866384 -
Targeted Temperature Management After Intracerebral Hemorrhage
|
Phase 2 | |
Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
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 | |
Terminated |
NCT00822796 -
Thermogard™ Efficacy Trial
|
N/A | |
Completed |
NCT00904228 -
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
|
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 |