UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023633 |
|---|---|
| Receipt number | 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 02:13:30 |
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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
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
ishiwatat@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Departments of Respirology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027216
