Transitional Care Study 3

NCT03923127 | Completed

• 1 other identifier: ICBE-2-27377
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

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

  3 weeks

Secondary Outcomes (3)

• Accuracy HealthDot

  2 weeks

• Comfort of wearing measured by questionnaire

  at week 2

• Accuracy Elan

  3 weeks

Study Arms (1)

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).

Other: Elan and HealthDot

Interventions

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).

Elan and HealthDot

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead

Study Sites (1)

Catharina Hospital

Eindhoven, 5623EJ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36804173 DERIVED

Study Officials

• Eveline Mestrom

  Catharina Hospital, Eindhoven, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: April 16, 2019
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)