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NCT03923127: TRICA

Transitional Care Study 3

Completed NA Last updated 28 August 2020
What this trial tests

NA trial testing Elan and HealthDot in Surgery--Complications in 350 participants. Completed in 17 August 2020.

Timeline
16 April 2019
Primary endpoint
17 August 2020
17 August 2020

Quick facts

Lead sponsorPhilips Electronics Nederland B.V. acting through Philips CTO organization
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment350
Start date16 April 2019
Primary completion17 August 2020
Estimated completion17 August 2020
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 18 to 85, any sex, with Surgery--Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Reliability of heart rate and respiration rate measurements with a wireless accelerometer in postbariatric recovery.
    Jacobs F, Scheerhoorn J, Mestrom E, van der Stam J, et al · · 2021 · cited 30× · PMID 33909642 · DOI 10.1371/journal.pone.0247903
  2. The Accuracy of Wrist-Worn Photoplethysmogram-Measured Heart and Respiratory Rates in Abdominal Surgery Patients: Observational Prospective Clinical Validation Study.
    van der Stam JA, Mestrom EHJ, Scheerhoorn J, Jacobs FENB, et al · · 2023 · cited 10× · PMID 36804173 · DOI 10.2196/40474
  3. Machine Learning for Postoperative Continuous Recovery Scores of Oncology Patients in Perioperative Care with Data from Wearables.
    van den Eijnden MAC, van der Stam JA, Bouwman RA, Mestrom EHJ, et al · · 2023 · cited 8× · PMID 37177659 · DOI 10.3390/s23094455
  4. Postoperative circadian patterns in wearable sensor measured heart rate: a prospective observational study.
    Mestrom EHJ, van der Stam JA, Nienhuijs SW, de Hingh IHJT, et al · · 2024 · cited 3× · PMID 37864755 · DOI 10.1007/s10877-023-01089-z

Verify or expand the search:

Other recruiting trials for Surgery--Complications

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03923127.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing