I95.9
Conditions
Interventions
Group 1: We will include adult patients scheduled for elective non-cardiac surgery under general anesthesia and planned postoperative treatment on the normal ward.
We monitor and record blood pressur
Sponsors
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: We will include adult patients (=18 years) with an American Society of Anesthesiologists physical status classification of II, III, or IV scheduled for elective non-cardiac surgery under general anesthesia that is expected to last =60 minutes and planned postoperative treatment on the normal ward.
Exclusion criteria
Exclusion criteria: We will not include patients with contraindications to the use of the Biobeat wrist-sensor (e.g. localized infections, ulcerations, or skin lesions, known allergy to metals, plastic and silicone). Also, we will not include patients participating in interventional trials, pregnant patients, or patients unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of monitoring time patients have any abnormal vital sign (peripheral oxygen saturation =91%, respiratory rate =8 breaths per min or =25 breaths per min, systolic arterial pressure =90 mmHg or =220 mmHg, or heart rate =40 beats per min or =131 beats per min) within the first five postoperative days in patients treated on the normal ward after non-cardiac surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint #1: Cumulative time patients have any abnormal vital sign. Secondary endpoint #2: Number of patients who have any abnormal vital sign for at least 5, 15, or 30 continuous minutes. Secondary endpoint #3: Cumulative time patients have each single abnormal vital sign. Secondary endpoint #4: Number of patients who have each single abnormal vital sign for at least 5, 15, or 30 continuous minutes. Secondary endpoint #5: Areas below or above the respective vital sign thresholds. Secondary endpoint #6: Time-weighted averages below or above the respective vital sign thresholds (i.e., areas below or above the respective vital sign thresholds divided by the monitoring time). Exploratory aims: - To investigate the association between the cumulative time patients had any abnormal vital sign and the collapsed composite of postoperative complications within 7 days after surgery. - To investigate the associations between areas below or above each respective vital sign threshold and postoperative complications. All variables for the endpoints will be continuously recorded using the wrist-monitor for 5 days after noncardiac surgery. | — |
Countries
Germany
Contacts
Public ContactMoritz Flick
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed