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Temporal Artery Thermometer in Patient Transport: Reliability and Validity. (TAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920943
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Body Temperature Other: Measurement of temperature using non-invasive means Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Temporal Artery Thermometer in Patient Transport: a Study of Reliability and Validity.
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
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.
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).




Primary Outcome Measures :
  1. Inter-method reliability [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920943


Contacts
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Contact: Russell MacDonald, MD MPH FRCPC (+1) 647 428 2034 rmacdonald@ornge.ca

Locations
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Canada, Ontario
Ornge Transport Medicine
Mississauga, Ontario, Canada, L4W5H8
Sponsors and Collaborators
Ornge Transport Medicine
Investigators
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Principal Investigator: Fuad Alnaji, MD FRCPC Ornge Transport Medicine
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Responsible Party: Ornge Transport Medicine
ClinicalTrials.gov Identifier: NCT03920943    
Other Study ID Numbers: Ornge 2018-01
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ornge Transport Medicine:
patient transfer