Correlation, Accuracy, Precision and Practicability of Ze... | NCT02031159

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

NCT02031159

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

May 16, 2014Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Hypothermia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 1, 2014

First Submission Date that Met QC Criteria

Jan 7, 2014

First Posted Date

Jan 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2014

Last Update Posted Date

May 16, 2014Estimated

Name	Class
3M	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
body core temperature (°C)		body core temperature taken at 15 min after induction of anesthesia

Secondary Outcomes

Measure	Description	Time Frame
body core temperature (°C)		body core temperature taken at 45 min after induction of anesthesia

Other Outcomes

Measure	Description	Time Frame
body core temperature (°C)		body core temperature taken at 75 min after induction of anesthesia

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients older than 16 years undergoing elective surgery in either gynecology or trauma surgery with a planned surgery time > 60 min.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Hoecker, MD	Klinik fur Anästhesiologie und Operative Intensivmedizin	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin		Kiel	Schleswig-Holstein	24105	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21444968	Background	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.
25693138	Derived	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.

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms