Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia

Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia; a Prospective Cohort Study

In pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia.

Study Overview

• Status: Unknown
• Conditions: Hypothermia
• Intervention / Treatment: Device: Non-invasive temperature in hypothermia

Detailed Description

The study is a prospective cohort study on patients undergoing elective thoracic surgery in deep hypothermia. The goal is to assess the accuracy of non-invasive temperature devices compared to a gold standard representing core temperature.

At the study hospital, Oslo University Hospital Rikshospitalet, patients undergoing thoracic surgery will already have several routes of temperature monitoring as part of standard procedure. Before cardiopulmonary bypass bladder temperature is normally used as a reference for core temperature. After cardiopulmonary bypass is established, temperature is monitored directly in the circulating blood, hence reflecting core temperature.

For measuring the epitympanic temperature we will use the Metraux Epitympanic Thermometer (Walpoth, Galdikas et al. 1994), a nasopharyngeal temperature probe (Mon-a-Therm, General Purpose Temperature Probe 12Fr/Ch, Covidien) and a new transcutaneous device (SpotOn 3M). The temperature will be measured in degrees Celsius. The first reading will be noted just after induction of anaesthesia and compared to the bladder temperature. After cardiopulmonary bypass (CPB) is established and therapeutic hypothermia is induced, the values for both non-invasive and blood temperature will be recorded every minute. After reaching the target temperature according to the blood temperature, we will continue recording the non-invasive temperature until relative similarity is established. The process will be repeated during re-warming.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital, Rikshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective thoracic surgery in deep hypothermia

Description

Inclusion Criteria:

• Adult >18 years
• Elektive cardiac surgery in deep hypothermia
• No pathology in ear canal on otoscopy

Exclusion Criteria:

• Pathology in ear canal
• non-consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-invasive temperature in hypothermia; Adult patients undergoing elective thoracic surgery in deep hypothermia	Device: Non-invasive temperature in hypothermia; accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature; Other Names: metraux epitympanic, nasopharyngeal, 3M spotOn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature in degrees celsius	The temperature reading from the epitympanic thermometer will be recorded every two minutes during deep hypothermia and compared to the temperature measured in the cardiopulmonary bypass circuit.	The patients will be followed during the induced per-operative hypothermia, an expected average of 1,5 hours.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Leiv Arne Rosseland, MD, Phd, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2015
• Study Completion (ANTICIPATED): March 1, 2016

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (ESTIMATE): December 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Temperature; hypothermia; pre-hospital; epitympanic
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: scs-2013