Validation of the Measurement Accuracy of the Tcore Therm... | NCT04489927

Studies
Validation of the Measurement Accuracy of the Tcore Thermometer

NCT04489927

Sponsor

Drägerwerk AG & Co. KGaA

Status

Terminated

Last Update Posted

Aug 22, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Temperature Change, Body

Interventions

Tcore

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patients couldn't be recruited (no patients with fewer available)

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Apr 11, 2023Actual

Completion Date

Apr 17, 2023Actual

First Submitted Date

Jul 24, 2020

First Submission Date that Met QC Criteria

Jul 27, 2020

First Posted Date

Jul 28, 2020Actual

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

Aug 17, 2023

Last Update Posted Date

Aug 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

Detailed Description

Patients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.

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

75Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tcore	Device	Temperature Measurement of standard care versus the Tcore measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Temperature	Temperature measurements with reference thermometer Tcore®	within 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body temperature > 34 °C
Signed consent
Bladder catheter with temperature sensor

Exclusion Criteria:

Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)
Skin irritation to the adhesive or other materials used
medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)
Taking antipyretics in the last 120 minutes before measurement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients in the ICU of the University Hospital Schleswig-Holstein

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Graf, Dr.	University Schleswig-Holstein Lübeck	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Schleswig-Holstein		Lübeck		23538	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001832	Body Temperature Changes

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided