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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023633
Receipt No. R000027216
Scientific Title Assessment of usefulness of capnographic monitoring during bronchoscopy under sedation.
Date of disclosure of the study information 2016/08/16
Last modified on 2018/08/18

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Basic information
Public title Assessment of usefulness of capnographic monitoring during bronchoscopy under sedation.
Acronym Assessment of usefulness of capnographic monitoring during bronchoscopy under sedation.
Scientific Title Assessment of usefulness of capnographic monitoring during bronchoscopy under sedation.
Scientific Title:Acronym Assessment of usefulness of capnographic monitoring during bronchoscopy under sedation.
Region
Japan

Condition
Condition Pulmonary diseases
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of capnography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of total duration time under 90% in SpO2.
Key secondary outcomes Comparison of median values in lowest levels of SpO2

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Smart CapnoLine Guardian(Medtronic), Capnostream 20P (Medtronic)
During bronchoscopy
Interventions/Control_2 Normal cannula tube
During bronchoscopy
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 1. Patients age is more than 20 years old.
2. Patient to perform bronchoscopy
3. Informed consent for using sedatives.
Key exclusion criteria 1. Patients undergo therapeutic bronchoscopy.
2. Patients without sedatives.
3. Patients who cannot be attached to oral device.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsukasa Ishiwata
Organization Chiba university
Division name Department of respirology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Email tatsumi@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukasa Ishiwata
Organization Chiba university
Division name Department of respirology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Homepage URL
Email ishiwatat@chiba-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Departments of Respirology
Institute
Department

Funding Source
Organization Graduate School of Medicine, Chiba University
Departments of Respirology
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 08 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.karger.com/Article/FullText/489888
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 Completed
Date of protocol fixation
2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 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 08 Month 15 Day
Last modified on
2018 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027216

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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