AzTrials
AzTrials

HypoxiaACW2NCT05542732

Accuracy of CardioWatch 287-2 During Profound Hypoxia

A study testing CardioWatch 287-2 in people with Hypoxia, run by Corsano Health B.V. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia
What is being tested?
CardioWatch 287-2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBelgium
Study dates
4 Jun 2022to 27 Jun 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Heavy smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
  • Individuals subject to conditions that result in elevated levels of methemoglobin
  • Individuals with hypoxia (SpO2 < 95 % at 21 % of oxygen)
  • Severe claustrophobia
  • Subject is known with altitude disease
  • The subject is obese (BMI ≥ 31 kg/m2).
Show all 19Show fewer
  • The subject has a known history of moderate to severe heart disease, lung disease, kidney or liver disease.
  • The subject is diagnosed with moderate to severe asthma.
  • 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.
  • The subject has any other serious systemic illness.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity or allergy to local anesthetics or disinfectants.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator.
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
  • The subject has any other condition, which in the opinion of the investigators would make the subject unsuitable for the study.
  • The subject refuses to remove nail-vanish.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Complementair Medisch Centrum (CMC) Europe

    Genk, 3600

Other trials in Belgium

About this study

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.

Conditions
Hypoxia
Being tested
CardioWatch 287-2
Keywords
oxygen saturation, heart rate, respiratory rate, SpO2, wrist wearable, PPG, Corsano, CardioWatch 287-2, accuracy
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioWatch 287-2Device

    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.

Study groups in NCT05542732
Study groupRoleWhat they receive
Single groupExperimentalEach 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.
Receives: Device: CardioWatch 287-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulse Oximetry

    SpO2

    Measured: 1 hour

  2. Pulse rate

    Heart rate in beats per minutes

    Measured: 1 hour

  3. Respiratory rate

    In breaths per minutes

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2022
  2. Study start4 Jun 2022
  3. Primary completion18 Jun 2022
  4. Study completion27 Jun 2022

Resources

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
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
A sample size of twelve subjects was planned in both the non-invasive study and invasive study, as recommended by the FDA Guidance for Industry and FDA Staff Pulse Oximeters - Premarket Notification Submissions \[510(k)s\]. Of these subjects, at least a minimum of 2 subjects or 15% of the analyzed population needed to have a dark skin pigmentation and at least 30 % of one gender is preferred.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05542732
Sponsor's protocol ID
CIV-21-12-038447
Acronym
ACW2
Status last verified
Sep 2022
First submitted
9 Sep 2022
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CardioWatch 287-2 in people with Hypoxia, run by Corsano Health B.V. at 1 site in Belgium.

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 3 inclusion and 19 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 15 Sep 2022. 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 Belgium. 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?

Pulse Oximetry (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 NCT05542732.

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 15 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in