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Validation of a non-invasive in-ear sensor for oxygen saturation, heart rate and body core temperature measurement

Validation of a non-invasive in-ear sensor for oxygen saturation, heart rate and body core temperature measurement - PhyLDS-0

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012848
Enrollment
10
Registered
2017-08-09
Start date
2017-08-29
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

Validation measurement accuracy of a non-invasive in-ear sensor for body temperature, heart rate and oxygen saturation

Interventions

Group 1: The sensor is placed in the patients ear before surgery. Body temperature, heart rate and oxygen saturation are then measured during operation. The data are then compared with the records of

Sponsors

Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • = 18 years • Citizen of the European Union • Open thoracic surgery

Exclusion criteria

Exclusion criteria: • Limitation to consent • ear anomaly

Design outcomes

Primary

MeasureTime frame
Is the non-invasive in-ear sensor able to measure heart rate, oxygen saturation, and body core temperature over a long-term period accurately compared to standard intraoperative measurement instruments (electrocardiography, bladder temperature measurement and pulse oximetry)?

Secondary

MeasureTime frame
Do kinematics of non-invasive in-ear sensor and standard intraoperative temperature measurement differ with regard to a change in the body temperature?

Countries

Germany

Contacts

Public ContactDavid Ellebrecht

Universitätsklinikum Schleswig-Holstein, Campus LübeckKlinik für Chirurgie

David.Ellenrecht@uksh.de0451 500 40101

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026