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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024975
Receipt No. R000028739
Scientific Title Effectiveness of respiratory rate monitoring using non-invasive methods
Date of disclosure of the study information 2016/11/24
Last modified on 2016/11/24

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Basic information
Public title Effectiveness of respiratory rate monitoring using non-invasive methods
Acronym Effectiveness of respiratory rate monitoring using non-invasive methods
Scientific Title Effectiveness of respiratory rate monitoring using non-invasive methods
Scientific Title:Acronym Effectiveness of respiratory rate monitoring using non-invasive methods
Region
Japan

Condition
Condition patients who undergo surgeries at Gifu university hospital
Classification by specialty
Surgery in general Gastrointestinal surgery Vascular surgery
Obsterics and gynecology Dermatology Orthopedics
Urology Cardiovascular surgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We assess respiration rate using clinical respiratory rate monitoring (capnometry and plethysmography) and compare with auscultation of throat breathing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes respiratory rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 a oxygen mask with capnometry
Interventions/Control_2 a nasal oxygen cannula with capnometry
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA physical status 1-2
20 years old or older
agreed to participate in the study and signed informed consent form
Key exclusion criteria Patients with severe cerebra-vascular disease,coronary heart disease or respiratory failure
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Yamada
Organization Gifu University Graduate School of Medicine
Division name Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu City, Gifu
TEL 058-230-6404
Email y-comet@wg7.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Yamada
Organization Gifu University Graduate School of Medicine
Division name Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu City, Gifu
TEL 058-230-6404
Homepage URL
Email y-comet@wg7.so-net.ne.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 24 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 24 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028739

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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