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Completed

NCT Number: NCT02031159

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

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. body core temperature (°C)

    Time frame: body core temperature taken at 15 min after induction of anesthesia

Secondary outcomes

  1. body core temperature (°C)

    Time frame: body core temperature taken at 45 min after induction of anesthesia

Other outcomes

  1. body core temperature (°C)

    Time frame: body core temperature taken at 75 min after induction of anesthesia

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2014
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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