Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring

NCT ID: NCT02031159

Last Updated: 2014-05-16

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

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-12-31

Brief Summary

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Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.

Detailed Description

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Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported such as bleeding, infection rate, cardiac complications, prolonged wound healing and patient discomfort. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring. Measurements are performed with the SpotOn® sensor by Arizant Healthcare, Inc..

Conditions

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Hypothermia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* elective surgery in gynecology or trauma surgery
* planned surgery time \> 60 min
* patients older than 16 years

Exclusion Criteria

* emergency surgery
* need for post-surgery ventilation
* patient's denial to take part in the study
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Jan Hoecker

PD Dr. Jan Höcker

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Hoecker, MD

Role: STUDY_DIRECTOR

Klinik fur Anästhesiologie und Operative Intensivmedizin

Locations

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Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

References

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Teunissen LP, Klewer J, de Haan A, de Koning JJ, Daanen HA. Non-invasive continuous core temperature measurement by zero heat flux. Physiol Meas. 2011 May;32(5):559-70. doi: 10.1088/0967-3334/32/5/005. Epub 2011 Mar 28.

Reference Type BACKGROUND
PMID: 21444968 (View on PubMed)

Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232.

Reference Type DERIVED
PMID: 25693138 (View on PubMed)

Other Identifiers

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THER-ZeroHeatFlux

Identifier Type: -

Identifier Source: org_study_id

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