Comparing the accuracy of non-invasive sensors for measuring the core body temperature with the gold standard pulmonary catheter in cardiac surgery patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027003

Enrollment

Registered

2021-10-28

Start date

2020-11-12

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

Perioperative hypothermia

Interventions

Group 1: We conduct a comparative prospective observational study between three temperature measurement methods. After a patient has been included in the study, a pumonal artery catheter is placed dur

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Medical indication for the installation of a pulmonary artery catheter for perioperative monitoring

Exclusion criteria

Exclusion criteria: Impossibility of inserting a pulmonary artery catheter or contraindications to its application.

Design outcomes

Primary

Measure	Time frame
Deviation of the temperature (in degrees Celsius) of the sensors compared to the core body temperature measurements from the pulmonary catheter. This is defined as the “limits of agreement” of the Bland-Altman analysis, which should not exceed +/- 0.5 ° C.	—

Secondary

Measure	Time frame
Sensitivity and specificity for hypo- and hyperthermia, the deviation of the ZHF and DS sensors from one another, as well as the measurement accuracy in different subgroups of the patient collective.	—

Countries

Germany

Contacts

Public ContactGeorg Engelbart

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Anästhesiologie und Intensivmedizin

georg.engelbart@uksh.de045150040701

Outcome results

None listed

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