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Transitional Care Study 3 (TRICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03923127
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Electronics Nederland BV

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.

Condition or disease Intervention/treatment Phase
Surgery--Complications Other: Elan and HealthDot Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PJ-013483 FLAGSHIP Transitional Care Study 3
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923127


Contacts
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Contact: Joerg Liebmann, PhD +31-(0)628498405 joerg.liebmann@philips.com

Locations
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Netherlands
Catharina Hospital Recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Eveline Mestrom         
Sponsors and Collaborators
Philips Electronics Nederland BV
Investigators
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Principal Investigator: Eveline Mestrom Catharina Hospital, Eindhoven, The Netherlands

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Responsible Party: Philips Electronics Nederland BV
ClinicalTrials.gov Identifier: NCT03923127     History of Changes
Other Study ID Numbers: PJ-013483
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No