Patients undergoing elective or urgent cardiac surgery in whom continuous monitoring of body temperature, heart rate, and oxygenation is required.
Conditions
Interventions
Group 1: In all enrolled patients undergoing cardiac surgery, continuous recording of vital parameters is performed using a multimodal, non-invasive in-ear sensor (c-med° alpha). Core body temperature
Sponsors
Universitätsmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (=18 years). Planned cardiac surgery, with or without the use of a heart–lung machine. Requirement for extended perioperative monitoring, including: invasive arterial temperature measurement (PiCCO catheter), monitoring of cerebral oxygenation using optical sensors. Normal findings of the external ear canal, allowing safe placement of the in-ear sensor. Written informed consent prior to study participation.
Exclusion criteria
Exclusion criteria: Lack of written informed consent or withdrawal of consent at any point. Pathological findings of the external ear canal, including pain or discomfort during placement of the in-ear sensor, preventing safe or reliable use. Patients under 18 years of age. Inability to participate due to short-notice changes in the surgical schedule (e.g., cancellation or rescheduling of the operation). Patient request to discontinue participation after data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Temperature WHAT: Agreement between in-ear sensor temperature and arterial reference temperature (PiCCO®). WHEN: From induction of anesthesia until the morning of postoperative day 1. HOW: Bland–Altman analysis (bias, 95% limits of agreement), ICC, MAPE. 2. Oxygen Saturation WHAT: Agreement between in-ear SpO2 and simultaneously measured cerebral oxygenation (rSO2) via NIRS. WHEN: Intraoperatively. HOW: Bland–Altman analysis (bias, 95% limits of agreement), Pearson correlation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Heart Rate WHAT: Agreement between in-ear heart rate and ECG-derived heart rate. WHEN: From start of surgery until the morning of postoperative day 1. HOW: Bland–Altman analysis, ICC, Pearson correlation, MAPE (only data points with quality index QI > 70). 2. Detection of Hypothermia/Hyperthermia WHAT: Sensitivity and specificity of in-ear temperature to detect hypothermia ( 38 °C). WHEN: Entire perioperative monitoring period. HOW: Contingency tables, PPV, NPV. 3. Data Quality WHAT: Proportion of usable in-ear measurements (temperature, SpO2, heart rate). WHEN: Entire observation period. HOW: Quantification of data loss in relation to predefined quality thresholds (QI, perfusion index). 4. Patient Acceptance and Tolerability WHAT: Patient-reported acceptance and tolerability of the in-ear sensor. WHEN: Postoperative day 1. HOW: Standardized questionnaire (Likert-scale assessment). | — |
Countries
Germany
Contacts
Public ContactMartin Friedrich
Universitätsmedizin Göttingen
Outcome results
None listed