UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease.
Title of the study (Brief title)	Clinical usefulness of pulse oxi-capnometer, CapnoEye.
Region	Japan

Condition
Condition	Respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical usefulness of pulse oxi-capnometer, CapnoEye, in patients with respiratory disease by calculating correlation coefficient between PaCO2 and EtCO2.
Basic objectives2	Others
Basic objectives -Others	Correlation of PaCO2 and EtCO2
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the performance of CapnoEye by calculating correlation coefficient between PaCO2 measured with arterial blood gas and EtCO2 measured by CapnoEye.
Key secondary outcomes	- 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).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	60

Research contact person
Name of lead principal investigator	Toshio Ichiwata
Organization	Tokyo Medical University, Hachioji Medical Center
Division name	Respiratory Medicine
Address	1163 Tatemachi, Hachioji, Tokyo
TEL	042-665-5611
Email	ichiwata@tokyo-med.ac.jp

Public contact
Name of contact person	Toshio Ichiwata
Organization	Tokyo Medical University, Hachioji Medical Center
Division name	Respiratory Medicine
Address	1163 Tatemachi, Hachioji, Tokyo
TEL	042-665-5611
Homepage URL
Email	ichiwata@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University, Hachioji Medical Center Respiratory Medicine
Institute
Department

Funding Source
Organization	Japan Precision Instruments Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	・東京医科大学八王子療センター（東京都/Tokyo Medical University, Hachioji Medical Center ・東北大学病院（宮城県）/Tohoku University Hospital ・八尾徳洲会総合病院（大阪府）/Yao Tokushukai general hospital

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 15 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2017 Year 08 Month 25 Day
Date of closure to data entry	2017 Year 08 Month 25 Day
Date trial data considered complete	2017 Year 09 Month 08 Day
Date analysis concluded	2017 Year 09 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	- The correlation between PaCO2 measured by arterial blood gas analyzer invasively and EtCO2 measured by pulse oxi-capnometer, CapnoEye, which was investigational device was studied. - Sixty patients in total were enrolled, with age 67.4+/-14.1 (mean+/-SD), 37 (61.7%) males and 23 (38.3%) females. - Their primary diseases are COPD for 21 cases (35.0%), asthma 5 (8.3%), idiopathic interstitial pneumonia 13 (8.3%), and others 26 (43.3%). - Correlation coefficient between PaCO2 and EtCO2 for patients of per protocol set (PPS, n=59) was r=0.815 and its regression line formula was y=1.065x - 4.783 (95% CI 0.864 - 1.266) (p<0.001). - Sub-analysis for PPS showed that high level of correlation coefficient between PaCO2 and EtCO2 was observed in groups of gender, age, inpatient or outpatient, and various type of respiratory diseases. - The study also suggested that correlation between respiration rate and EtCO2 was not clear, and an appropriate pattern of breathing rhythm for each individual patient could effect the accuracy of CapnoEye. - No adverse event and malfunction was observed. - Usefulness of CapnoEye in various respiratory disease care would be expected not only for inpatient but also outpatient as home-care equipment.
Other related information	The inpatient or outpatient of the institute is regarded as a candidate for the subject. Parameters recorded by CapnoEye are EtCO2, SpO2, respiratory rate and pulse rate.

Management information
Registered date	2017 Year 03 Month 29 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030724