Surgery--ComplicationsTRICANCT03923127
Transitional Care Study 3
A study testing Elan and HealthDot in people with Surgery--Complications, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Elan and HealthDot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Apr 2019to 17 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery--Complications
- Being tested
- Elan and HealthDot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elan and HealthDotOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Elan and HealthDot | Experimental | 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). Receives: Other: Elan and HealthDot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
Evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data from both devices.
Measured: 3 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start16 Apr 2019
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eveline Mestrom, Principal investigator, Catharina Hospital, Eindhoven, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923127
- Sponsor's protocol ID
- ICBE-2-27377
- Acronym
- TRICA
- Status last verified
- Aug 2020
- First submitted
- 17 Apr 2019
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Stam JA, Mestrom EHJ, Scheerhoorn J, Jacobs FENB, Nienhuijs S, Boer AK, van Riel NAW, de Morree HM, Bonomi AG, Scharnhorst V, Bouwman RA. The Accuracy of Wrist-Worn Photoplethysmogram-Measured Heart and Respiratory Rates in Abdominal Surgery Patients: Observational Prospective Clinical Validation Study. JMIR Perioper Med. 2023 Feb 20;6:e40474. doi: 10.2196/40474.
PubMed 36804173
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PJ-013483 FLAGSHIP Transitional Care Study 3
- ClinicalTrials.gov ID
- NCT03923127
- Acronym / sponsor ID
- TRICA / ICBE-2-27377
- Conditions
- Surgery--Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elan and HealthDot | Experimental | Other: Elan and HealthDotPatients 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elan and HealthDotPatients 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 |
Primary outcome
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.
3 secondary outcomes
Accuracy HealthDot
Time frame: 2 weeks
Comfort of wearing measured by questionnaire
Time frame: at week 2
Accuracy Elan
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Derived from this study: PubMed 36804173van der Stam JA, Mestrom EHJ, Scheerhoorn J, Jacobs FENB, Nienhuijs S, Boer AK, van Riel NAW, de Morree HM, Bonomi AG, Scharnhorst V, Bouwman RA. The Accuracy of Wrist-Worn Photoplethysmogram-Measured Heart and Respiratory Rates in Abdominal Surgery Patients: Observational Prospective Clinical Validation Study. JMIR Perioper Med. 2023 Feb 20;6:e40474. doi: 10.2196/40474.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eveline Mestrom principal investigator
Catharina Hospital, Eindhoven, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elan and HealthDot in people with Surgery--Complications, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.