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Trial record 27 of 6395 for:    zero

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

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ClinicalTrials.gov Identifier: NCT02031159
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
PD Dr. Jan Hoecker, University of Schleswig-Holstein

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.

Condition or disease
Hypothermia

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..

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia




Primary Outcome Measures :
  1. body core temperature (°C) [ Time Frame: body core temperature taken at 15 min after induction of anesthesia ]

Secondary Outcome Measures :
  1. body core temperature (°C) [ Time Frame: body core temperature taken at 45 min after induction of anesthesia ]

Other Outcome Measures:
  1. body core temperature (°C) [ Time Frame: body core temperature taken at 75 min after induction of anesthesia ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 16 years undergoing elective surgery in either gynecology or trauma surgery with a planned surgery time > 60 min.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031159


Locations
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Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
3M
Investigators
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Study Director: Jan Hoecker, MD Klinik fur Anästhesiologie und Operative Intensivmedizin

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. Jan Hoecker, PD Dr. Jan Höcker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02031159     History of Changes
Other Study ID Numbers: THER-ZeroHeatFlux
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by PD Dr. Jan Hoecker, University of Schleswig-Holstein:
perioperative hypothermia
zero heat flux
non-invasive measurement of body core temperature
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms