Temporal Artery Thermometer in Patient Transport: Reliability and Validity.

NCT ID: NCT03920943

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-06-30

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.

Conditions

Body Temperature

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Core and TAT measurements

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.

Group Type: OTHER

Measurement of temperature using non-invasive means

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ornge Transport Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fuad Alnaji, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Ornge Transport Medicine

Locations

Ornge Transport Medicine

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

Ornge 2018-01

Identifier Type: -

Identifier Source: org_study_id