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Prospective Evaluation of the Temple Touch Pro Temperature Monitoring System compared to Esophageal Reference Temperature in Pediatric Anesthesia

Prospective Evaluation of the Temple Touch Pro Temperature Monitoring System compared to Esophageal Reference Temperature in Pediatric Anesthesia - PETER-PAN

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024703
Enrollment
100
Registered
2021-03-04
Start date
2021-04-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T88.5

Interventions

Group 1: Simultaneous temperature measurement using Temple Touch Pro Temperature Monitoring System sensors on the forehead and an esophageal temperature probe

Sponsors

Klinik für AnästhesiologieUniversitätsmedizin Göttingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children < 7 years who need continuous measurement of core body temperature under general anesthesia 2. Preoperative informed consent of parents / legal guardians

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in the investigation 2. Surgical interventions in which the positioning of the Temple Touch Pro temperature sensors (certain interventions on the head or known intolerance to the adhesive of the sensor) or the esophageal temperature probe are not possible (e.B. oral/neck interventions) 3. Patients with esophagus diseases in which a probe cannot be placed in the esophagus

Design outcomes

Primary

MeasureTime frame
Analysis of whether there are clinically relevant differences in the measurement accuracy of the Temple Touch Pro temperature monitoring system compared to the reference method (bias, that reflects the mean differences between the two methods = accuracy)

Secondary

MeasureTime frame
Calculation of how much % of the data differs from the reference temperature by more ±0.5°C. Analysis of other subgroups (age, possibly other patient factors, temperature range of the core body temperature, time course, room temperature, sonographically determined depth of the temporal artery)

Countries

Germany

Contacts

Public ContactMarcus Nemeth

Universitätsmedizin Göttingen Klinik für Anästhesiologie

marcus.nemeth@med.uni-goettingen.de+49551/39-67701

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026