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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026762
Receipt No. R000030724
Scientific Title Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease.
Date of disclosure of the study information 2017/03/30
Last modified on 2018/01/26

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Basic information
Public title Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease.
Acronym Clinical usefulness of pulse oxi-capnometer, CapnoEye.
Scientific Title Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease.
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshio Ichiwata
Organization Tokyo Medical University, Hachioji Medical Center
Division name Respiratory Medicine
Zip code
Address 1163 Tatemachi, Hachioji, Tokyo
TEL 042-665-5611
Email ichiwata@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Ichiwata
Organization Tokyo Medical University, Hachioji Medical Center
Division name Respiratory Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 02 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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