Accuracy of CardioWatch 287-2 During Profound Hypoxia

NCT05542732 | Completed

• 1 other identifier: CIV-21-12-038447
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Pulse Oximetry

  SpO2

  1 hour

• Pulse rate

  Heart rate in beats per minutes

  1 hour

• Respiratory rate

  In breaths per minutes

  1 hour

Study Arms (1)

Single group

EXPERIMENTAL

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

CardioWatch 287-2 DEVICE

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.

Single group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corsano Health B.V.: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Complementair Medisch Centrum (CMC) Europe

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raf de Jongh, MD, PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 15, 2022
• Study Start: June 4, 2022
• Primary Completion: June 18, 2022
• Study Completion: June 27, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)