Back to resultsAccuracy of CardioWatch 287-2 During Profound Hypoxia (ACW2)
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CardioWatch 287-2
Sponsored by
About this trial
This is an interventional screening trial for Hypoxia focused on measuring oxygen saturation, heart rate, respiratory rate, SpO2, wrist wearable, PPG, Corsano, CardioWatch 287-2, accuracy
Eligibility Criteria
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.
Sites / Locations
- Complementair Medisch Centrum (CMC) Europe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single group
Arm Description
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.
Outcomes
Primary Outcome Measures
Pulse Oximetry
SpO2
Pulse rate
Heart rate in beats per minutes
Respiratory rate
In breaths per minutes
Secondary Outcome Measures
Full Information
NCT ID
NCT05542732
First Posted
September 9, 2022
Last Updated
September 13, 2022
Sponsor
Corsano Health B.V.
Collaborators
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT05542732
Brief Title
Accuracy of CardioWatch 287-2 During Profound Hypoxia
Acronym
ACW2
Official Title
Accuracy of CardioWatch 287-2 During Profound Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2022 (Actual)
Primary Completion Date
June 18, 2022 (Actual)
Study Completion Date
June 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corsano Health B.V.
Collaborators
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
oxygen saturation, heart rate, respiratory rate, SpO2, wrist wearable, PPG, Corsano, CardioWatch 287-2, accuracy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CardioWatch 287-2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulse Oximetry
Description
SpO2
Time Frame
1 hour
Title
Pulse rate
Description
Heart rate in beats per minutes
Time Frame
1 hour
Title
Respiratory rate
Description
In breaths per minutes
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raf de Jongh, MD, PhD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complementair Medisch Centrum (CMC) Europe
City
Genk
ZIP/Postal Code
3600
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Accuracy of CardioWatch 287-2 During Profound Hypoxia
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