UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012494 |
|---|---|
| Receipt number | R000014629 |
| Scientific Title | Mask ventilation under general anesthesia: Influences of obstructive sleep apnea |
| Date of disclosure of the study information | 2013/12/05 |
| Last modified on | 2016/01/05 12:10:46 |
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Basic information
Public title
Mask ventilation under general anesthesia: Influences of obstructive sleep apnea
Acronym
obstructive sleep apnea and mask ventilation difficulty
Scientific Title
Mask ventilation under general anesthesia: Influences of obstructive sleep apnea
Scientific Title:Acronym
obstructive sleep apnea and mask ventilation difficulty
Region
| Japan |
Condition
Condition
Patients shceduled for elective surgeries under general anesthesia
Classification by specialty
| Pneumology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test an hypothesis that presence of obstructive sleep apnea increases difficulty of mask ventilation during anesthesia induction
Basic objectives2
Others
Basic objectives -Others
To explore pathophysiology of difficult mask ventilation during anesthesia induction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of breathes first achieving normal capnogram wave form during mask ventilation under general anesthesia
Key secondary outcomes
tidal volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
obstructive sleep apnea
Interventions/Control_2
non-obstructive sleep apnea
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective surgeries under general anesthesia
Key exclusion criteria
Patients who are eligible for awake intubation, patients with full stomach, patients with severe co-morbidities, and patients with allergy for rocuronium or propofol are excluded.
Target sample size
80
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
Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL
043222-7171
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, Chuo-ku, Chiba Japan
TEL
043-222-7171
Homepage URL
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Grant from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 12 | Month | 05 | 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 | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014629
| 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 |
