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RecruitingNCT07893405Updated Oct 26, 2026

Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable

An observational study in Monitoring, ECG and Electrocardiogram, sponsored by GE Healthcare. Recruiting at 1 site in Finland. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by GE Healthcare · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 26, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study summary

This study aims to evaluate the performance and usability of a new physiological monitoring technology by collecting data from subjects across different age groups to support device development and clinical evaluation.

Read the detailed description

The purpose of this study is to assess the performance, usability, and safety of an investigational physiological monitoring technology in neonates, children, adults, and elderly subjects. The study will collect electrocardiogram (ECG) and respiration-related data, including assessment of performance under specific clinical conditions. The data generated will be used to improve measurement technologies, support product development, and provide clinical evidence for safety, performance, and regulatory compliance.

02

Conditions studied

  • Monitoring
  • ECG
  • Electrocardiogram

Keywords

  • monitoring
  • ECG
  • Electrocardiogram
03

In context

Lead sponsor

GE Healthcare is the lead sponsor of 176 studies on the registry; 21 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Browse GE Healthcare studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults, elderly, neonates and pediatric patients treated in Helsinki University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
  2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
  3. ECG can be collected

Exclusion criteria

Exclusion Criteria:

  1. Are known to be pregnant*
  2. Are breastfeeding; OR,
  3. Are suffering from infection(s) or immunocompromised patients that require isolation.
  4. PI or caring physician decision due to subject health condition
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Primary Outcome

    ECG performance and user-reported usability of the new ECG device

    Time frame: Up to 24 hours after time of enrollment

Secondary outcomes

  1. Secondary Outcome

    Parameter raw data recorded by the ECG device

    Time frame: Up to 24 hours after time of enrollment

Other outcomes

  1. Safety Outcome

    Number and type of adverse events, serious adverse events, and device deficiencies

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Helsinki University Hospital
    Espoo, 02740, Finland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 26, 2026
StartActual
Apr 9, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893405
Lead sponsor
GE Healthcare
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Apr 9, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 26, 2026

Study contacts

Tero Varpula Principal Investigator
Contact
tero.varpula@hus.fi
+35894711

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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