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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015650
Receipt No. 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

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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
Email 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
Email joto@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018195

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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