UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022183 |
|---|---|
| Receipt number | R000024919 |
| Scientific Title | Evaluation of mask ventilation efficacy by cricoid pressure |
| Date of disclosure of the study information | 2016/05/03 |
| Last modified on | 2016/06/16 10:38:18 |
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Basic information
Public title
Evaluation of mask ventilation efficacy by cricoid pressure
Acronym
Mask ventilation efficacy bt cricoid pressure.
Scientific Title
Evaluation of mask ventilation efficacy by cricoid pressure
Scientific Title:Acronym
Mask ventilation efficacy bt cricoid pressure.
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia with rapid induction.
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the mask ventilation efficacy by cricoid pressure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mask ventilation efficacy for ventilation volume or intratracheal pressure
Key secondary outcomes
Subhective difficult of anesthesiologists
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
1Mask ventilation with cricoid pressure
2Mask Ventilation without cricoid pressure
Interventions/Control_2
1Mask Ventilation without cricoid pressure
2Mask ventilation with cricoid pressure
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia with rapid induction.
Key exclusion criteria
Patients with anticipated mask ventilation difficulty or GER.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Anesgthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 05 | Month | 03 | 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
Ventilation volume by pressure controlled ventilation was reduced by cricoid pressure at 10, 15, 20 cmH2O.
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 | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjective difficuty of manual ventilation did not significantly differ.
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2016 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024919
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
