Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever

NCT01503294 | Completed

• 1 other identifier: TAT-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Fever

Keywords

Temporal artery thermometer; Pulmonary artery thermistor

Outcome Measures

Primary Outcomes (1)

• accuracy and precision of the TAT as compared to the PAT

  Recorded temperature from the PAT and then collected TAT temperature.

  1 minute

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may qualify if:

• Pulmonary artery catheter in place for a clinical indication,
• fever \> 100.4oF

You may not qualify if:

• significant carotid or cerebrovascular disease,
• PA catheter is not in proper position as confirmed by chest x-ray

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diane L Carroll, PhD, RN

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 4, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

US (1)