ACW2: Accuracy of CardioWatch 287-2 During Profound Hypoxia

Sponsor

Corsano Health B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT05542732

Collaborator

Ziekenhuis Oost-Limburg (Other)

Enrollment

Location

Arm

Actual Duration (Days)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia	Device: CardioWatch 287-2	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Screening

Official Title:

Accuracy of CardioWatch 287-2 During Profound Hypoxia

Actual Study Start Date :

Jun 4, 2022

Actual Primary Completion Date :

Jun 18, 2022

Actual Study Completion Date :

Jun 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Pulse Oximetry [1 hour]
SpO2
Pulse rate [1 hour]
Heart rate in beats per minutes
Respiratory rate [1 hour]
In breaths per minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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).
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.