UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019578 |
|---|---|
| Receipt number | R000022635 |
| Scientific Title | Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2017/05/01 10:34:20 |
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Basic information
Public title
Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea
Acronym
Influences of muscle paralysis and lung volume on hyoid bone position
Scientific Title
Influences of general anesthesia and lung volume change on upper airway configuration: impact of obesity and obstructive sleep apnea
Scientific Title:Acronym
Influences of muscle paralysis and lung volume on hyoid bone position
Region
| Japan |
Condition
Condition
Adult Patients undergoing general anesthesia
Classification by specialty
| Pneumology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test hypotheses that 1) induction of general anesthesia results in cranial shift of the hyoid bone particularly in patients with obstructive sleep apnea, 2)lung volume increase during general anesthesia results in cranial shift of the hyoid bone particularly in obese obstructive sleep apnea patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
hyoid bone position
Key secondary outcomes
craniofacial dimensions, patient characteristics, severity of obstructive sleep apnea, obesity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
head and neck radiography and lung volume increase
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
1. General anesthesia is scheduled for the surgery.
2. Adult male who is older than or equal to 40 years old and younger than or equal to 70 years old.
Key exclusion criteria
1. Patients American Society of Anesthesiologists Physical Status greater than 3
2. Patients with upper airway abnormalities.
3. Patients with severe COPD.
4. Patients with uncontrolled asthma.
5. Patients with aonea hypopnea index between 10 and 15
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL
+81432262155
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL
+81432262155
Homepage URL
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japanese Grants-in-Aid for Scientific Research (Kakenhi)
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
Chiba University Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 04 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022635
