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

Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02031159
Enrollment
120
Registered
2014-01-09
Start date
2013-10-31
Completion date
2013-12-31
Last updated
2014-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Keywords

perioperative hypothermia, zero heat flux, non-invasive measurement of body core temperature

Brief summary

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

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..

Interventions

None listed

Sponsors

3M
CollaboratorINDUSTRY
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
body core temperature (°C)body core temperature taken at 15 min after induction of anesthesia

Secondary

MeasureTime frame
body core temperature (°C)body core temperature taken at 45 min after induction of anesthesia

Other

MeasureTime frame
body core temperature (°C)body core temperature taken at 75 min after induction of anesthesia

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026