UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015650 |
|---|---|
| Receipt number | R000018195 |
| Scientific Title | Effects of dexmedetomidine on preventing sleep disturbance and delirium during high flow oxygen therapy in patients with acute respiratory failure. |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2019/11/14 09:40:29 |
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Basic information
Public title
Effects of dexmedetomidine on preventing sleep disturbance and delirium during high flow oxygen therapy in patients with acute respiratory failure.
Acronym
Dexmedetomidine for sleep disturbance and delirium during high flow oxygen therapy
Scientific Title
Effects of dexmedetomidine on preventing sleep disturbance and delirium during high flow oxygen therapy in patients with acute respiratory failure.
Scientific Title:Acronym
Dexmedetomidine for sleep disturbance and delirium during high flow oxygen therapy
Region
| Japan |
Condition
Condition
Adult patients with acute respiratory failure treated with high flow oxygen therapy
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of dexmedetomidine on preventing sleep disturbance and delirium during high flow oxygen therapy in adult patients with acute respiratory failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep quality and quantity (total sleep time, the rate of each sleep stage: non-REM sleep stage 1-3, REM sleep) and the incidence rate of delirium.
Key secondary outcomes
successful rate of liberation from high flow oxygen therapy, the length of ICU stay, and mortality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine 0.2-0.7mcg/kg/h for nocturnal sedation
Interventions/Control_2
No sedation or sedation without dexmedetomidine during night time.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients with acute respiratory failure equipped with high flow oxygen therapy in the intensive care units.
Key exclusion criteria
Major cardiovascular disease, shock, cerebrovascular disease, known sleep apnea syndrome, mental disorder.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Oto |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho Tokushima-city Tokushima, Japan
TEL
088-633-9347
joto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Oto |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho Tokushima-city Tokushima, Japan
TEL
088-633-9347
Homepage URL
joto@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Emergency and Critical Care Medicine, The University of Tokushima Graduate School
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
Clinical trial center for developmental of therapeutics
Address
2-50-1 Kuramoto-cho Tokushima
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2019 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018195
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
