Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia

NCT ID: NCT02009059

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypothermia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-invasive temperature in hypothermia

Adult patients undergoing elective thoracic surgery in deep hypothermia

Non-invasive temperature in hypothermia

Intervention Type DEVICE

accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature

Interventions

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Non-invasive temperature in hypothermia

accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature

Intervention Type DEVICE

Other Intervention Names

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metraux epitympanic, nasopharyngeal, 3M spotOn

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leiv Arne Rosseland, MD, Phd

Role: STUDY_DIRECTOR

Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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scs-2013

Identifier Type: -

Identifier Source: org_study_id

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