Title
Accuracy of Respiratory Rate measurement by CardioWatch287-2 in patients (ACW2-PAT)

Background
The aim of the present study is to compute the accuracy of CW2 in terms of respiratory rate (RR) in patients at habitual breathing rates. Study device is CW2, and benchmark device for RR is physician confirmed respiratory rate defined on basis of the behavior of CO2 measured at the entrance of the nose/mouth of the participants for all volunteers.

Study Design
RR will be obtained by FDA cleared Reference Device General Electric® Carescape B850 cleared under K131414 with an oxygen mask Oxymask OM-1125-8 with an anesthesia gas sampling line of 2 m. Based on the capnographic CO2, a physician will note/affirm the RR value twice a minute as reference value for computation of CW2 accuracy in patients. One hour measurement of RR by CW2 and Reference Device will be performed on 18 adult patients suffering cardiac, neurologic or respiratory diseases and Arms will be computed. RR measurement by the physician based on CO2 expiration will include 120 measurements at the TPI during a one-hour period. As such, a total of more than 2000 synchronized benchmark and test device measurements will be included in the statistical analysis. The study will be non-interventional. The study will be executed at OLV-Ziekenhuis-Aalst under supervision of Dr. N. De Neve.

Inclusion criteria for the ACW2-PAT study
1. Patients admitted to the hospital
2. The subject is aged ≥18 years.
3. Stable condition as measured by vital signs monitoring or clinical symptoms
4. Patient fulfill one of the following criteria before inclusion
    - patient suffer proven cardiac pathologies
    - patient suffer respiratory problems,
    - patient suffer neurological problems.
5. The subject is not intellectually disabled, has provided informed consent and is willing to comply with the study procedures including wearing a (extra) nasal tube for air aspiration.

Exclusion criteria for the ACW2-PAT study
1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
2. Patient has an ASA score of I or V.
3. Patient is not able to stay in a supine position during 1 hour.
4. Patient ≤ 18 years.
5. Patient has a BMI > 32.
6. The patient has any other condition which, in the opinion of the medical investigators, would make the patient unsuitable for the study, such as, but not limited to, ataxia, Parkinson, severe anemia, severe depression, ECMO, low perfusion
7. The patient does not breathe spontaneously or is in need of any mechanical assistance for respiration.
8. Any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigators, would interfere with correct measurements.

Study center
OLV Ziekenhuis in Aalst, Belgium

Start time, Duration
January 2024, 2 months