Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04489927
Status:
TERMINATED
Last Update Posted:
2023-08-22
First Post:
2020-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the Measurement Accuracy of the Tcore Thermometer
Sponsor:
Drägerwerk AG & Co. KGaA
Organization:
Study Overview
Official Title:
Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients couldn't be recruited (no patients with fewer available)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T-CORE-PMCF
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:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: