FeverNCT01503294
Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever
An observational study of Fever, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fever
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- Pulmonary artery catheter in place for a clinical indication,
- fever > 100.4oF
Who cannot join
- significant carotid or cerebrovascular disease,
- PA catheter is not in proper position as confirmed by chest x-ray
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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 100.4oF. 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 100.4oF.
Read the 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 37.8oC (100.0oF) with some methodological criticism, compared the TAT to PAT in adults (n=15). There were poor correlations (r=0.3) among the adult measurements with a difference of 1.3+0.6o 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 100.4oF is defined as a fever and a temperature of 100.9oF 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.
- Conditions
- Fever
- Keywords
- Temporal artery thermometer, Pulmonary artery thermistor
- Medical subject headings
- Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy and precision of the TAT as compared to the PAT
Recorded temperature from the PAT and then collected TAT temperature.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane L. Carroll, Massachusetts General Hospital
- Investigators
- Diane L Carroll, PhD, RN, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503294
- Sponsor's protocol ID
- TAT-1
- Status last verified
- Jun 2014
- First submitted
- 30 Dec 2011
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever
- ClinicalTrials.gov ID
- NCT01503294
- Acronym / sponsor ID
- TAT-1
- Conditions
- Fever
- Keywords
- Temporal artery thermometer, Pulmonary artery thermistor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 100.4oF. 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 100.4oF.
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 37.8oC (100.0oF) with some methodological criticism, compared the TAT to PAT in adults (n=15). There were poor correlations (r=0.3) among the adult measurements with a difference of 1.3+0.6o 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 100.4oF is defined as a fever and a temperature of 100.9oF 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (2 listed)
- Pulmonary artery catheter in place for a clinical indication,
- fever > 100.4oF
Key exclusion criteria (2 listed)
- significant carotid or cerebrovascular disease,
- PA catheter is not in proper position as confirmed by chest x-ray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy and precision of the TAT as compared to the PAT
Time frame: 1 minute
Recorded temperature from the PAT and then collected TAT temperature.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane L Carroll, PhD, RN principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy and precision of the TAT as compared to the PAT (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.