Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01503294
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2011-12-30
Brief Title:
Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assessment and evaluation of body temperature is an important sign of health and disease Inferior thermometry increases the risk of morbidity and mortality and increases health care cost by delaying the diagnosis and treatment of fever-related disease The gold standard for measuring core body temperature is the pulmonary artery thermistor PAT The measurement of the PAT requires the insertion of the invasive pulmonary artery catheter a high risk procedure
An innovative thermometry technology the temporal artery thermometer TAT has been introduced into the clinical arena as a potential non-invasive proxy for the PAT The TAT reduces the risk and cost of pulmonary artery catheter insertion by non-invasively measuring core blood temperature by measuring temperature over the skin of the temporal artery
Research to demonstrate the precision and accuracy of the TAT in normothermic patients has been published but little to no data is available in those with temperatures greater than 1004oF The purpose of this study is to measure the precision and accuracy of 2standard of care temperature methods the thermistor from the PAT considered the gold standard and the TAT as measured in those patients with a PAT temperature greater than 1004oF
An innovative thermometry technology the temporal artery thermometer TAT has been introduced into the clinical arena as a potential non-invasive proxy for the PAT The TAT reduces the risk and cost of pulmonary artery catheter insertion by non-invasively measuring core blood temperature by measuring temperature over the skin of the temporal artery
Research to demonstrate the precision and accuracy of the TAT in normothermic patients has been published but little to no data is available in those with temperatures greater than 1004oF The purpose of this study is to measure the precision and accuracy of 2standard of care temperature methods the thermistor from the PAT considered the gold standard and the TAT as measured in those patients with a PAT temperature greater than 1004oF
Detailed Description:
The results from previous studies agree that direct comparisons of the PAT and TAT are clinically comparable in the normal temperature range in adults This was defined as a clinical significance difference of less than 5ºC 9ºF In the one study that assessed subjects with fevers temperatures greater than 378oC 1000oF with some methodological criticism compared the TAT to PAT in adults n15 There were poor correlations r03 among the adult measurements with a difference of 1306o C Eighty-nine percent of the TAT measurements were different than the PAT by more that 5ºC
With only one study that focused in those who had a PAT outside the normal temperature range to evaluate accuracy and precision there is a need for further research to assess the accuracy and precision of the TAT for detection of hyperthermia A new onset of temperature equal to or above 1004oF is defined as a fever and a temperature of 1009oF is considered a reasonable trigger for a clinical assessment according to the Society of Critical Care Medicine in their fever guidelines for adults Researchers synthesizing the literature on the TAT and other noninvasive temperature measurements indicate that noninvasive temperature measurements are accurate for normal temperatures but may fail to detect hyperthermia and hypothermia depending on the thermometer used The authors concluded that the TAT is clinically comparable to the PAT in only the normal temperature range
A repeated measures design will be used to describe the accuracy and precision of 2 temperature measurements the PAT and the TAT Study subjects will act as their own control in order to investigate the difference in PAT readings and the TAT readings in both the core and oral mode The PAT will also be compared to the TAT reading taken by the clinical staff
With only one study that focused in those who had a PAT outside the normal temperature range to evaluate accuracy and precision there is a need for further research to assess the accuracy and precision of the TAT for detection of hyperthermia A new onset of temperature equal to or above 1004oF is defined as a fever and a temperature of 1009oF is considered a reasonable trigger for a clinical assessment according to the Society of Critical Care Medicine in their fever guidelines for adults Researchers synthesizing the literature on the TAT and other noninvasive temperature measurements indicate that noninvasive temperature measurements are accurate for normal temperatures but may fail to detect hyperthermia and hypothermia depending on the thermometer used The authors concluded that the TAT is clinically comparable to the PAT in only the normal temperature range
A repeated measures design will be used to describe the accuracy and precision of 2 temperature measurements the PAT and the TAT Study subjects will act as their own control in order to investigate the difference in PAT readings and the TAT readings in both the core and oral mode The PAT will also be compared to the TAT reading taken by the clinical staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None