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Trial record 27 of 6496 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

Tracking Information
First Submitted Date January 1, 2014
First Posted Date January 9, 2014
Last Update Posted Date May 16, 2014
Study Start Date October 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2014)
body core temperature (°C) [ Time Frame: body core temperature taken at 15 min after induction of anesthesia ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02031159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 7, 2014)
body core temperature (°C) [ Time Frame: body core temperature taken at 45 min after induction of anesthesia ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 7, 2014)
body core temperature (°C) [ Time Frame: body core temperature taken at 75 min after induction of anesthesia ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring
Official Title Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement
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..
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hypothermia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 7, 2014)
120
Original Actual Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02031159
Other Study ID Numbers THER-ZeroHeatFlux
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PD Dr. Jan Hoecker, University of Schleswig-Holstein
Study Sponsor University of Schleswig-Holstein
Collaborators 3M
Investigators
Study Director: Jan Hoecker, MD Klinik fur Anästhesiologie und Operative Intensivmedizin
PRS Account University of Schleswig-Holstein
Verification Date May 2014