UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026011 |
|---|---|
| Receipt number | R000029373 |
| Scientific Title | Effect of keeping mouth open on mask ventilation in induction of general anesthesia |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2018/08/09 11:07:34 |
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Basic information
Public title
Effect of keeping mouth open on mask ventilation in induction of general anesthesia
Acronym
Effect of keeping mouth open on mask ventilation in induction of general anesthesia
Scientific Title
Effect of keeping mouth open on mask ventilation in induction of general anesthesia
Scientific Title:Acronym
Effect of keeping mouth open on mask ventilation in induction of general anesthesia
Region
| Japan |
Condition
Condition
Patients sheceduled for surgeries under genera anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the effect of keeping mouth open on mask ventilation in induction of general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of ventilation on mask ventilation in induction of general anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Not keeping mouth open on mask ventilation
Interventions/Control_2
keeping mouth open with both hands on mask ventilation
Interventions/Control_3
keeping mouth open with bite block on mask ventilation
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for surgeries under general anesthesia
Key exclusion criteria
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 | Ayano Tai |
Organization
Toyooka hospital
Division name
Department of Anesthesiology
Zip code
Address
1094, Tobera, Toyooka-shi, Hyogo
TEL
0796226111
amssisters@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayano Tai |
Organization
Toyooka hospital
Division name
Department of Anesthesiology
Zip code
Address
1094, Tobera, Toyooka-shi, Hyogo
TEL
0796226111
Homepage URL
amssisters@yahoo.co.jp
Sponsor or person
Institute
Toyooka hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2017 | Year | 02 | Month | 20 | 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
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
| 2016 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029373
