Patients, scheduled for surgery e.g. bariatric and major surgery such as cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC), complex rectal surgery, esophagectomy and pancreatectomy.
Conditions
Interventions
None listed
Sponsors
Philips Electronics Nederland B.V., acting through Research, Eindhoven, NL
Eligibility
Inclusion criteria
Inclusion criteria: • Adult • Willing and able to sign informed consent form • Willingness to abstain from visiting a sauna during the study period • Willingness to dry area where the HealthDot is applied in a dipping fashion after washing • Willingness to abstain from flying during the study period of time • Elective surgery • General anesthesia required for surgery
Exclusion criteria
Exclusion criteria: • General inmates of psychiatric wards, prisons, or other state institutions • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study • Any skin condition, for example prior rash, discoloration, scars or open wounds at the area of investigation of both devices • Pregnant, or breastfeeding • Known to be allergic for the tissue adhesive used in the HealthDot. • Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions) • Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker • Unable to understand instructions • Expected participation less than 2 weeks • Left lower rib (place where HealthDot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed. • Area on arm where the Elan device is applied is involved in the surgical procedure. • Patients with antibiotic resistant infections (e.g. MRSA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data calculated based on accelerometer and/or PPG measurements. The deterioration is primarily defined as complication according to Clavien Dindo classification grade II or higher. Complications are further assessed by the following events: · Unplanned ICU admission · Rapid Response Team (RRT) visit to patient · Start of antibiotics · Re-surgery · Radiologic intervention such as abscess drainage · Suppletion of erythrocytes, thrombocytes and Fresh Frozen Plasma · Increase in early warning scores · Readmission after discharge · Death | — |
Secondary
| Measure | Time frame |
|---|---|
| • Agreement of the calculated heart rate and respiratory rate compared to the gold standard. • Description of the extent of hampering in daily activities by both devices as assessed by the patients. | — |
Contacts
Public ContactJoerg Liebmann
Philips Electronics Nederland BV, acting through Research, Eindhoven, NL
Outcome results
None listed