Clinical trial NCT03920943: Temporal Artery Thermometer in Patient Transport: Reliability and Validity.
Official title: Temporal Artery Thermometer in Patient Transport: a Study of Reliability and Validity.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Body Temperature
Keywords: patient transfer
Lead sponsor: Ornge Transport Medicine
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Inter-method reliability
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Ornge Transport Medicine
state: Ontario
Study officials:
affiliation: Ornge Transport Medicine
name: Fuad Alnaji, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: