Clinical trial NCT03923127: Transitional Care Study 3
Official title: PJ-013483 FLAGSHIP Transitional Care Study 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan). The HealthDot will measure heart rate, posture, activity and respiratory rate which are stored on the device as well as sent to Philips. The Elan device will measure PPG and accelerometer data which is transferred to Philips. The data collected will be used for algorithm development. Data will be analysed retrospectively and compared to readmission and adverse events to see if the events could have been predicted due to the collected data by the devices. No clinical decisions will be based on the measurements done during the study.


Eligibility 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:

* 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 resitant infections (e.g. MRSA).

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 3 weeks
Secondary outcomes:
measure: Accuracy HealthDot
timeFrame: 2 weeks
measure: Comfort of wearing measured by questionnaire
timeFrame: at week 2
measure: Accuracy Elan
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
affiliation: Catharina Hospital, Eindhoven, The Netherlands
name: Eveline Mestrom
role: PRINCIPAL_INVESTIGATOR
References: