Transitional Care Study 3 (TRICA)

PJ-013483 FLAGSHIP Transitional Care Study 3

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.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: Elan and HealthDot

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands, 5623EJ
    • Catharina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elan and HealthDot; 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).	Other: Elan and HealthDot; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity	Evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data from both devices.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy HealthDot	Evaluate if the calculated heart rate and respiratory rate data collected by HealthDot are accurate compared to a gold standard as used in the hospital	2 weeks
Comfort of wearing measured by questionnaire	Comfort of wearing the HealthDot will be assessed by VAS scale 1-10 while 1 beeing very comfortable, and 10 very uncomfortable	at week 2
Accuracy Elan	Evaluate if the calculated heart rate and respiratory rate data collected by Elan are accurate compared to a gold standard as used in the hospital	3 weeks

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Investigators: Principal Investigator: Eveline Mestrom, Catharina Hospital, Eindhoven, the Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): August 17, 2020
• Study Completion (Actual): August 17, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ICBE-2-27377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No