Confirmatory clinical trial for evaluating the effectiveness and safety of respiration monitoring using AirTom-RM

Multi-center clinical trials of BiLab’s AirTom-RM100 to validate its equivalence with a diagnostic spirometer in terms of tidal volume, respiration rate and minute ventilation measurements

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005972

Enrollment

Registered

2021-03-08

Start date

2021-03-02

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : After attaching AirTOM-RM to subjects who are suspected of having respiratory abnormalities from 21 years of age or older to under 99 years of age, they are simultaneously measured us

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Volunteers aged 21 to under 99 Volunteers with or without respiratory disease(asthma, COPD,obstructive sleep apnea) Patients recovering after surgical anesthesia or taking opioid analesics

Exclusion criteria

Exclusion criteria: Patients with electronic medical devices such as pacemakers and implantable defibrillators Patients with skin damage Highly obese patients with a body obesity index of 40 or higher Those who are pregnant or lactating After thoracic surgery Within 1 month after myocardial infarction Nonspecific hypersensitivity of the bronchi

Design outcomes

Primary

Measure	Time frame
relative errors of tidal volume, respiration rate, and minute ventilation	—

Secondary

Measure	Time frame
Bias, precision, accuracy	—

Countries

Korea, Republic of

Contacts

Public ContactSung Wan Kim

Kyung Hee University

Outcome results