Temporal Artery Thermometer in Patient Transport: Reliability and Validity.

Body Temperature Clinical Trial

— TAT  

Official title:

Temporal Artery Thermometer in Patient Transport: a Study of Reliability and Validity.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03920943
• Other study ID #: Ornge 2018-01
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2021
• Source: Ornge Transport Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the reliability and validity of temperature measurements using an existing, Health Canada-approved, non-invasive temporal artery thermometer, and comparing results to an established, invasive gold standard (esophageal probe), in order to assess reliability of this non-invasive method to measure core body temperature in the setting of patients undergoing inter-facility patient transport by land, rotor-wing, and fixed-wing transport vehicles.

Description:

Interfacility patient transport can put the patient at risk a drop in body temperature. This drop can harmful to patients with particular illnesses (trauma, stroke, post cardiac arrest), and the very young or old. Measuring temperature and preventing temperature drops are challenging in the transport setting. The temporal artery thermometer (TAT) is widely available, easy to use, non-invasive way to measure body temperature. TAT is believed to be a good tool for paramedics to measure body temperature in the transport setting. However, the evidence on reliability and validity of TAT-derived temperature measurements is lacking because the TAT has not been evaluated in the transport setting. The goal of this study is to evaluate the reliability of the TAT device and compare measures of temperature with an established standard in a broad range of patients undergoing interfacility transport by land ambulance, and rotor- and fixed-wing aircraft.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The study will include patients who meet all of the following criteria:

• intubated
• mechanically ventilated
• transported for emergent or urgent indications
• transported between January 1 and December 31, 2019. Exclusion Criteria:

The study will exclude patients with any one of the following:

• transports non-urgent conditions
• scheduled transports (for appointment, repatriations, or similar)
• patients who are not intubated and mechanically ventilated
• patients with contraindications to temperature probe insertion (esophageal stricture, varices or perforation; upper or lower gastrointestinal bleeding; congenital tracheo-esophageal abnormalities; post-operative patients with ear, nose, and throat or upper airway surgery; facial trauma or anatomic abnormalities; coagulopathy; anticoagulant use)
• scene responses
• patients transported posthumously
• patients in whom an invasive temperature monitoring probe was not inserted

Related Conditions & MeSH terms

• Body Temperature

Intervention

Other:
• Measurement of temperature using non-invasive means
The study intervention will involve paramedics using the TAT device to measure temperature non-invasively,the first measurements made at least 5 minutes after insertion of the temperature probe (control measurement #1), and also prior to departure from the sending facility (control measurement #2). Once the patient is in the transport vehicle and the vehicle in motion for at least 10 minutes, the paramedics will measure the patient's temperature non-invasively using the TAT. If the transport time exceeds 1 hour, additional measurements taken at 1 hour intervals for the duration of transport (up to a total of 8 hours).

Locations

Country	Name	City	State
Canada	Ornge Transport Medicine	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ornge Transport Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-method reliability	Paramedics will measure core temperature at least 5 minutes after invasive monitoring device insertion, prior to departure from the sending facility, once the transport vehicle in is motion for at least 10 minutes, and at 1 hour intervals thereafter (if transport time exceeds 1 hour). The invasive device will be placed by one paramedic, with the result recorded by the transport monitor. The other paramedic will simultaneously use the TAT to take the temperatures, documenting the results in the electronic patient care record.	Time frame 1: 5 minutes post insertion of invasive temperature probe. Time frame 2: 10 minutes after transport begins. Time frame 3: every hour until transport ends, up to 8 hours.