UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015394 |
|---|---|
| Receipt number | R000017905 |
| Scientific Title | Research on the respiration status in cancer patients with sedatives and analgesics |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2014/10/09 19:59:01 |
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Basic information
Public title
Research on the respiration status in cancer patients with sedatives and analgesics
Acronym
Research on the respiration status in cancer patients with sedatives and analgesics
Scientific Title
Research on the respiration status in cancer patients with sedatives and analgesics
Scientific Title:Acronym
Research on the respiration status in cancer patients with sedatives and analgesics
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the problematic respiratory status in cancer patients with sedatives and analgesics.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of respiratory event with SpO2<=90 per hour
Key secondary outcomes
Highest ETCO2
Respiratory rate per minute
Number of apnea per minute
Number of hypopnea per minute
Conscious level
Assessment of patient's respiratory status by medical staff
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Cancer patients who are expected to need sedatives and analgesics
2.Age>=20
3. Written informed consent
4.Fluent in Japanese
5.Hospitalized
Key exclusion criteria
1.Difficulty with attaching monitors
2.Within 7 days of operation
3.With respirator
4.Considered ineligible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Natsuko Taguchi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohanacho, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2155
nnoztag@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuko Taguchi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohanacho, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2155
Homepage URL
nnoztag@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Anesthesiology, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Sosiety for thr Promotion of science(JSPS)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
| 2014 | Year | 10 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017905
