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Completed

NCT Number: NCT03923127

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.

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Key information

Conditions

Surgery--Complications

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Hospital

Eindhoven, 5623EJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Elan and HealthDot

Other

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).

Primary outcomes

  1. Sensitivity and specificity

    Time frame: 3 weeks

    Evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data from both devices.

Secondary outcomes

  1. Accuracy HealthDot

    Time frame: 2 weeks

    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. Comfort of wearing measured by questionnaire

    Time frame: at week 2

    Comfort of wearing the HealthDot will be assessed by VAS scale 1-10 while 1 beeing very comfortable, and 10 very uncomfortable

  3. Accuracy Elan

    Time frame: 3 weeks

    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

Sponsors and collaborators

Lead sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization

Industry

Registry information

Official study title

PJ-013483 FLAGSHIP Transitional Care Study 3

Acronym: TRICA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2019
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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