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

NCT05516771 | Completed FDA Device

• 1 other identifier: DHF-TaSC
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Accuracy of Tcore core temperature measurements

  A scatterplot of differences between Tcore and standard measurements of body temperature,limits of agreement will be calculated using the method by Zou (2013).(23)

  For the duration of Anesthesia and a maximum of 12 hours

Secondary Outcomes (1)

• sensitivity and specificity

  For the duration of Anesthesia and a maximum of 12 hours

Study Arms (1)

group 1

toddlers and small children undergoing surgery at a tertiary referral, university-affiliated hospital

Device: Tcore™ system

Interventions

Tcore™ system DEVICE

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.

group 1

Eligibility Criteria

• Age: 0 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study population: toddlers and small children undergoing surgery at a tertiary referral, university-affiliated hospital

You may qualify if:

• years
• elective surgical procedures with a procedure time of more than 30 min
• operations for which insertion of a rectal temperature probe is clinically indicated as a routine method, (e.g., operations in regional anaesthesia)

You may not qualify if:

• rash or infection that prevents the application of the Heat flux thermometers.
• Fragile forehead skin state;
• known allergy to the probe adhesive or any constituent components
• maxillofacial trauma or lesions
• procedures impeding proper placement of the Tcore™ sensor
• neurologically impaired children with abnormal thermoregulation;
• hemodynamic instability; need for vasoactive medication;
• procedures associated with extended use of abdomino/thoracic rinsing fluids;
• thoracoscopic/thoracotomy procedures;
• malignant hyperthermia or family history of malignant hyperthermia
• patient with fever or infection;
• all conditions that might be judged to abnormally alter skin perfusion
• patients or their legal guardian are not willing to participate in the trial.

Sponsors & Collaborators

• Oliver Kimberger: lead

Study Sites (1)

Medical Univercity Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 26, 2022
• Study Start: October 1, 2022
• Primary Completion: February 26, 2023
• Study Completion: February 26, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)