UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011821 |
|---|---|
| Receipt number | R000012344 |
| Scientific Title | Dynamic behavior of the soft palate during mask ventilation |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2016/01/08 19:36:10 |
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Basic information
Public title
Dynamic behavior of the soft palate during mask ventilation
Acronym
Mask ventilation and soft palate
Scientific Title
Dynamic behavior of the soft palate during mask ventilation
Scientific Title:Acronym
Mask ventilation and soft palate
Region
| Japan |
Condition
Condition
Adult patients undergoing surgeries under general anesthesia
Classification by specialty
| Pneumology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test a hypothesis that incidence of expiratory obstruction at the soft palate during mask ventilation is higher in patients with sleep disordered breathing
Basic objectives2
Others
Basic objectives -Others
To explore differences between dynamic and static closing pressures of the velopharyngeal airway
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of velopharyngeal obstruction during expiration
Key secondary outcomes
velopharyngeal closing pressure during mask ventilation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
mask ventilation
Interventions/Control_2
sleep disordered breathing
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
adult patients scheduled for surgeries general anesthesia
Key exclusion criteria
Patients with severe cormobidities, high risk of aspiration,allergies for muscle relaxants and propofol, apparent upper airway structural abnormalities, difficult mask fit, full dentures
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Isono |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
Address
1-8-1,Inohana,Chuo-ku,Chiba-shi,Chiba
TEL
043-222-7171
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Isono |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
Address
1-8-1,Inohana,Chuo-ku,Chiba-shi,Chiba
TEL
043-222-7171
Homepage URL
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba university
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 20 | 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
| 2013 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2016 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012344
