Temporal Artery Thermometer in Patient Transport: Reliability and Validity.

Not Applicable

Withdrawn

• Conditions: Body Temperature
• Interventions: Other: Measurement of temperature using non-invasive means

• Registration Number: NCT03920943
• Lead Sponsor: Ornge Transport Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Study Start: 2019-09-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Core and TAT measurements	Measurement of temperature using non-invasive means	As part of the standard of care, flight paramedics will insert an esophageal or rectal temperature probe in patients meeting including criteria to enable continuous temperature monitoring. Paramedics will measure core temperature on at least two occasions, the first measurements made at least 5 minutes after insertion of the temperature probe, and also prior to departure from the sending facility.

Primary Outcome Measures

Name	Time	Method
Inter-method reliability	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.	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.

Trial Locations

Locations (1)

Ornge Transport Medicine; 🇨🇦 Mississauga, Ontario, Canada