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CompletedNCT05542732ACW2Updated Sep 15, 2022

Accuracy of CardioWatch 287-2 During Profound Hypoxia

An interventional study of CardioWatch 287-2 in Hypoxia, sponsored by Corsano Health B.V.. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by Corsano Health B.V. · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

In an individual's SpO2 range from 100 to 73 %, this study calibrates and evaluates the accuracy of SpO2 measurement by CW2 in comparison to reference pulse oximeter (Nellcor PM10) or CO-oximetry, Pulse rate (PR) and respiratory rate (RR) were calibrated based on the same Nellcor equipment and the frequency of end-tidal CO2 respectively.

Read the detailed description

The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 80601-2-61:2017, Corrected version 2018-02 and ISO 80601-2-55.

SpO2: Testing to confirm the accuracy of the SpO2 monitoring according to ISO 80601-2-61 Clause 201.12.1.101 201.12.1.101

RR Testing: Testing to confirm the accuracy of the respiration rate monitoring according to ISO 80601-2-55. Volunteers respirated spontaneously, no efforts were made to include all ranges of respiration during the study.

PR Testing: Testing to confirm the accuracy of the PR monitoring according to ISO 80601-2-61 Clause 201.12.1.104. No efforts were made to influence PRs of volunteers.

An accelerometer and PPG filters are built in CW2 in order to form the basis to exclude non-eligible test results.

02

Conditions studied

  • Hypoxia

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Keywords

  • oxygen saturation
  • heart rate
  • respiratory rate
  • SpO2
  • wrist wearable
  • PPG
  • Corsano
  • CardioWatch 287-2
  • accuracy
03

In context

Hypoxia

1,246 studies on the registry are indexed under Hypoxia; 239 are open to participants now.

This study's enrollment of 12 is below the median of 45 across 864 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Corsano Health B.V. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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. Healthy non-disabled subjects with American Society of Anesthesiologists health score (ASA) of 1 or 2.
  2. The subject is aged ≥18 and ≤ 65 years.
  3. The subject is not intellectual disabled, and has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Heavy smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
  2. Individuals subject to conditions that result in elevated levels of methemoglobin
  3. Individuals with hypoxia (SpO2 \< 95 % at 21 % of oxygen)
  4. Severe claustrophobia
  5. Subject is known with altitude disease
  6. The subject is obese (BMI ≥ 31 kg/m2).
  7. The subject has a known history of moderate to severe heart disease, lung disease, kidney or liver disease.
  8. The subject is diagnosed with moderate to severe asthma.
  9. The subject is known with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, ... who, in the opinion of the investigator, would make them unsuitable for study participation.
  10. The subject has any other serious systemic illness.
  11. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
  12. The subject has a history of fainting or vasovagal response.
  13. The subject has a history of sensitivity or allergy to local anesthetics or disinfectants.
  14. The subject has a diagnosis of Raynaud's disease.
  15. The subject has unacceptable collateral circulation based on exam by the investigator.
  16. The subject is pregnant, lactating or trying to get pregnant.
  17. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
  18. The subject has any other condition, which in the opinion of the investigators would make the subject unsuitable for the study.
  19. The subject refuses to remove nail-vanish.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Single group

    Each participant wore one CW2 sensor attached to the back of the wrist with a wrist band. Additionally, each participant wore a reference pulse oximeter (Nellcor PM10) attached to the middle finger of the ipsilateral hand. This enabled the comparison of the paired results of the CW2 sensor and reference pulse oximeter equipment for SpO2 measurements at different oxygen saturation levels. Twelve subjects of the 24 participants received an arterial catheter in the contralateral radial artery for exvivo SaO2 determination by CO-oximetry and in order to define the final accuracy of CW2 for SpO2 measurement.

    Device: CardioWatch 287-2

Interventions

  • DeviceCardioWatch 287-2

    CardioWatch 287-2 (CW2 Test Device or CW2). This medical device is based on the precursor CardioWatch 287-1 approved by EU-MDR under number 20M00011CRT01, CW2 has two red, two infrared and two green LEDs, and two photosensors compared to its precursor.

06

What researchers measure

Primary outcomes

  1. Pulse Oximetry

    SpO2

    Time frame: 1 hour

  2. Pulse rate

    Heart rate in beats per minutes

    Time frame: 1 hour

  3. Respiratory rate

    In breaths per minutes

    Time frame: 1 hour

07

Study locations

1 site
  • Complementair Medisch Centrum (CMC) Europe
    Genk, 3600, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Jun 2022, 0 months.

Of 32 industry-sponsored interventional studies with no phase under Hypoxia, half reached primary completion within 0 months of starting (the median), counting those still running; a quarter within 0 and three quarters within 5.

Counting every sponsor, half of 406 studies reached it within 13 months; a quarter within 4 and three quarters within 29.

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

Registered
Sep 9, 2022
First posted
Sep 15, 2022
StartActual
Jun 4, 2022
Primary completionActual
Jun 18, 2022
CompletionActual
Jun 27, 2022
Last update
Sep 15, 2022
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.
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05542732
Lead sponsor
Corsano Health B.V.
Collaborators
Ziekenhuis Oost-Limburg
Responsible party
Sponsor
First posted
Sep 15, 2022
Start date
Jun 4, 2022
Primary completion
Jun 18, 2022
Completion
Jun 27, 2022
Last update
Sep 15, 2022

Study contacts

Raf de Jongh, MD, PhD
principal investigator · Ziekenhuis Oost-Limburg

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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