NCT02009059

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

November 11, 2013

Last Update Submit

October 28, 2015

Conditions

Hypothermia

Keywords

hypothermiaTemperatureepitympanicpre-hospital

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Non-invasive temperature in hypothermia

Adult patients undergoing elective thoracic surgery in deep hypothermia

Device: Non-invasive temperature in hypothermia

Interventions

Non-invasive temperature in hypothermiaDEVICE

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

Also known as: metraux epitympanic, nasopharyngeal, 3M spotOn
Non-invasive temperature in hypothermia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective thoracic surgery in deep hypothermia

You may qualify if:

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

You may not qualify if:

  • Pathology in ear canal
  • non-consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0372, Norway

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leiv Arne Rosseland, MD, Phd

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

December 11, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

October 29, 2015

Record last verified: 2015-01

Locations

NO(1)