Temporal Artery Thermometer in Patient Transport: Reliability and Validity.

NCT03920943 | Withdrawn

• 1 other identifier: Ornge 2018-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature

Keywords

patient transfer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Core and TAT measurements

OTHER

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.

Other: Measurement of temperature using non-invasive means

Interventions

Measurement of temperature using non-invasive means 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).

Core and TAT measurements

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ornge Transport Medicine: lead

Study Sites (1)

Ornge Transport Medicine

Mississauga, Ontario, L4W5H8, Canada

Location

Study Officials

• Fuad Alnaji, MD FRCPC

  Ornge Transport Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a prospective cohort study of patients undergoing emergent or urgent interfacility patient transport by Ornge in Ontario, Canada. The study will include all patients, regardless of age, who are intubated and mechanically ventilated, and transported for emergent or urgent indications.

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: April 19, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)