Transitional Care Study 3

Surgery--Complications Clinical Trial

— TRICA  

Official title:

PJ-013483 FLAGSHIP Transitional Care Study 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923127
• Other study ID #: ICBE-2-27377
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: August 17, 2020

Study information

• Verified date: August 2020
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity	Evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data from both devices.	3 weeks
Secondary	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
Secondary	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
Secondary	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