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Evaluation of a Licensed Double-sensor-heat-flux (DHF) Non-invasive Core Temperature Sensor in Small Children and Toddlers Undergoing Surgery

NCT05516771 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2023-03-20

No results posted yet for this study

Summary

Title: Evaluation of a licensed double-sensor-heat-flux (DHF) non-invasive core temperature sensor in small children and toddlers undergoing surgery.

CI/PS identification code: DHF-TaSC Device Name: Tcore™ system (Tcore-Adapter MP00999 \& Tcore-Sensor MP 00989) Manufacturer: Drägerwerk AG \& CO KGaA Study design: Prospective, single arm, clinical study

Patients:

* Number: 72
* Age / gender: females and males between 0 and 7 years
* Patients of a tertiary referral, university-affiliated hospital undergoing surgery

Exclusion Criterions:

* Operation site, rash or infection that prevents the application of the heat flux thermometers.
* Patients and/or legal guardians not willing to participate in the trial.
* Patients older than 7 years Setting: ORs of a tertiary referral, university-affiliated hospital. Study variables: measurement triplets measured via two double-sensor-heat-flux (DHF) thermometer the Tcore™ (Dräger, Drägerwerk AG \& Co KG, 23558 Lübeck, Germany) one placed on the forehead and one on the upper belly and temperature measured by a rectally placed temperature probe.

Conditions

  • Hypothermia; Anesthesia

Interventions

DEVICE

Tcore™ system

The Tcore sensor is a double-sensor-heat-flux (DHF) thermometer and consist of two sensors separated by a known thermal resistance. One side is placed directly at the patient's skin and the other is facing the environment. After some equilibration time the core temperature can then be calculated. The sensors are placed above the eye and the sinus frontalis. Intended use The Tcore system is a thermometer intended for non-invasive, continuous measurement of the core body temperature of children from 5 years of age, adolescents, and adults. The Tcore system consists of a sensor and an adapter. The adapter is reusable. The sensor is intended for single use. The Tcore system works in adjusted mode, i.e., the core body temperature is determined by a dual sensor. Off-Label/Investigational Use In context of this clinical study the Tcore-system will be investigated outside its approved and intended use, namely in children below the age of five and toddlers.

Sponsors & Collaborators

  • Oliver Kimberger

    lead OTHER

Eligibility

Min Age
0 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-02-26
Completion
2023-02-26
FDA Device
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516771 on ClinicalTrials.gov