UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002362 |
|---|---|
| Receipt number | R000002900 |
| Scientific Title | Effect of daily sedative interruption on sleep stages in mechanically ventilated patients. |
| Date of disclosure of the study information | 2009/08/24 |
| Last modified on | 2011/01/17 10:29:31 |
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Basic information
Public title
Effect of daily sedative interruption on sleep stages in mechanically ventilated patients.
Acronym
Daily sedative interruption and sleep characteristics.
Scientific Title
Effect of daily sedative interruption on sleep stages in mechanically ventilated patients.
Scientific Title:Acronym
Daily sedative interruption and sleep characteristics.
Region
| Japan |
Condition
Condition
Mechanically ventilated patient
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of daily sedative interruption on sleep quality in mechanically ventilated patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep characteristics in night time period.
Key secondary outcomes
dosage of sedatives and analgesics in nighttime period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Daily sedative interruption
Interventions/Control_2
Continuous sedation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were intubated and expected to receive mechanical ventilation at least 48 h.
Key exclusion criteria
Patients who were the psychiatric illness, anoxic brain injury, suspected encephalopathy (drug overdose, hepatic failure), seizure disorder, and severe hemodynamic instability in whom systolic blood pressure was < 90mmHg despite vasopressor support
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Oto |
Organization
Tokushimma University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
Address
3-18-15 Kuramoto-cho Tokushima-city Tokushima Japan
TEL
088-633-9347
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Oto |
Organization
Tokushimma University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
Address
3-18-15 Kuramoto-cho Tokushima-city Tokushima Japan
TEL
088-633-9347
Homepage URL
joto@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Emergency and Critical Care Medicine Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Emergency and Critical Care Medicine Tokushima University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Patients in daily sedative interruption group showed increasing amount of stage 3 and 4 non rapid eye movement (NREM) sleep (6 min vs. 0 min, P = 0.04) and rapid eye movement (REM) sleep (54 min vs. 0 min, P = 0.02) compared with patients in continuous sedation group. In continuous sedation group, total sleep time during nighttime was longer (8.7 h vs. 7.3 h, P = 0.047) and frequency of arousal was lower (2.2 event/h vs. 4.4 event/h, P = 0.03) than those in daily sedative interruption group.
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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 21 | Day |
Last modified on
| 2011 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002900
| 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 |
