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Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease.

Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease. - Clinical usefulness of pulse oxi-capnometer, CapnoEye.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000026762
Enrollment
60
Registered
2017-03-30
Start date
2017-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Respiratory disease

Interventions

None listed

Sponsors

Tokyo Medical University, Hachioji Medical Center Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients whose PaCO2 is to be monitored and who agree to measure their EtCO2 simultaneously. 2. Patients who can understand the clinical study and who agree to participate in the study with the written informed consent. 3. Patients aged between 20 years and 85 years old. Or patients aged 16 years or over and less than 20 years at the time of Informed Consent with consent by legal representatives. 4. Inpatients or outpatients with respiratory / ventilatory dysfunction that range from mild to severe, who are able to follow the investigator's instructions.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to take continuous mouth-breaths at least 8 cycles. 2. Patients who are unable to understand investigator's instructions, e.g. dementia and psychiatric disease. 3. Patients who undergo with Photo Dynamic Therapy and/or defibrillator as combination therapy. 4. Any other cases who are considered as inappropriate for the study by the investigators.

Design outcomes

Primary

MeasureTime frame
To evaluate the performance of CapnoEye by calculating correlation coefficient between PaCO2 measured with arterial blood gas and EtCO2 measured by CapnoEye.

Secondary

MeasureTime frame
- The explorative sub-group analysis for tendency (high vs low PaCO2, obstructive/restrictive/mixed disease, relationship with respiration rate) - Safety data (medical device malfunction, adverse events).

Countries

Japan

Contacts

Public ContactToshio Ichiwata

Tokyo Medical University, Hachioji Medical Center Respiratory Medicine

ichiwata@tokyo-med.ac.jp042-665-5611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026