UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036541 |
|---|---|
| Receipt number | R000041634 |
| Scientific Title | Dose-dependent effects of head down tilt on cerebral circulation |
| Date of disclosure of the study information | 2019/04/18 |
| Last modified on | 2021/02/19 10:02:44 |
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Basic information
Public title
Effects of head down tilt on cerebral circulation
Acronym
Effects of head down tilt on cerebral circulation
Scientific Title
Dose-dependent effects of head down tilt on cerebral circulation
Scientific Title:Acronym
Dose-dependent effects of head down tilt on cerebral circulation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate dose-dependent effects of head down tilt on cerebral circulation.
Basic objectives2
Others
Basic objectives -Others
Physiological changes
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Gain, coherence and phase between arterial blood pressure and cerebral blood flow variabilities in the spine position, and head down tilt position (-10, -30 degrees)
Key secondary outcomes
Cerebral blood flow velocity, pulsatility index, blood pressure variability, respiratory indexes, intracranial pressure, baroreflex function, heart rate variability, skin blood flow
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Head-down tilt (-30 degrees) position for 10 min
Interventions/Control_2
Head-down tilt (-10 degrees) position for 10 min
Interventions/Control_3
Horizontal position, (0 degree) for 10 min
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults consented to participate in the study
Cerebral blood flow velocity signals in the middle cerebral artery can be obtained by transcranial Doppler ultrasonography.
Key exclusion criteria
Not satisfy selection criteria noted above
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | IWASAKI |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
TEL
03-3972-8111
iwasaki.kenichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kato |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
TEL
03-3972-8111
Homepage URL
kato.tomokazu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
Tel
03-3972-8111
med.kenjim@nihon-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
日本大学医学部
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 18 | 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
17
Results
Although nICP_BB increased during HDT30 compared to HDT0 (P<0.001), steady-state mean CBF velocity did not change (P=0.467). Transfer function gain in the low frequency did not change at any levels of head-down tilt (P=0.766), indicating unchanged dynamic cerebral autoregulation.
Conclusion: Contrary to our hypothesis, the present study suggests that steady-state CBF and dynamic cerebral autoregulation may not be altered by significant increases in intracranial pressure during 30 degrees head-down tilt.
Results date posted
| 2020 | Year | 10 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seventeen healthy people,(12 men, 5 women), age 24(2)yr
Participant flow
After explanation of this study to candidates by recruitment with the poster, all participants provided written informed consent as well as a medical history regarding circulation and were screened based on a physical examination including electrocardiography and blood pressure measurements. Exclusion criteria comprised failure to obtain CBF velocity signals in the right middle cerebral artery by transcranial Doppler ultrasonography.
Adverse events
None
Outcome measures
Arterial blood pressure waveforms obtained using a finger plethysmography
CBF velocity waveforms in the middle cerebral artery (MCA) obtained using transcranial Doppler ultrasonography
Non-invasive intracranial pressure estimated using black-box model (nICP_BB, ICM+)
Dynamic cerebral autoregulation evaluated by spectral and transfer function analysis between MAP oscillation and mean CBF velocity fluctuation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 21 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 21 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041634
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