Transitional Care Study 3 (TRICA)

Philips

Status: Completed

Conditions: Surgery--Complications

Treatments: Other: Elan and HealthDot

Study type: Interventional

Funder types: Industry

Identifiers

NCT03923127

ICBE-2-27377

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

Elan and HealthDot

Experimental group

Description:

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).

Treatment:

Other: Elan and HealthDot