PJ-013483 FLAGSHIP Transitional Care Study 3
- Conditions
- Patients, scheduled for surgery e.g. bariatric and major surgery such as cyto reductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC), complex rectal surgery, esophagectomy and pancreatectomypatients after surgery
- Registration Number
- NL-OMON48030
- Lead Sponsor
- Philips Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
- 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
- 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).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is to evaluate the sensitivity and specificity for the<br /><br>prediction of deterioration after surgery using the data calculated based on<br /><br>accelerometer and/or PPG measurements. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Agreement of the calculated heart rate and respiratory rate compared to the<br /><br>gold standard.<br /><br>* Description of the extent of hampering in daily activities by both devices as<br /><br>assessed by the patients.</p><br>