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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000017790 |
Receipt No. | R000020604 |
Scientific Title | Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation. |
Date of disclosure of the study information | 2015/06/03 |
Last modified on | 2018/06/05 |
Basic information | ||
Public title | Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation.
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Acronym | Incidence and Predictors of DMV and DLS, A Study of Preoperative Airway Evaluation.
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Scientific Title | Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation.
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Scientific Title:Acronym | Incidence and Predictors of DMV and DLS, A Study of Preoperative Airway Evaluation.
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Region |
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Condition | ||
Condition | Airway Management of General Anesthesia Induction | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The techniques of mask ventilation and intubation complement each other. Airway evaluation has been focused on difficult intubation.In 2013 multicenter study has been published in US.We tried to verify the validity of the 12 preoperative evaluation items to target the Japanese patients. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Incidence and Predictors of Difficult Mask Ventilation combined with Difficult Laryngoscopy |
Key secondary outcomes | Incidence and Predictors of DMV,
Incidence and Predictors of DLS, Rescue airway management techniques, Incidence and Airway Management of JSA-AMA Yellow zone |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Adult patients who had undergone surgery under general anesthesia started by rapid introduction at our hospital. | |||
Key exclusion criteria | Patients who had'nt been undergone mask ventilation during anesthesia induction, patients who had been planned awake intubation from the beginning, patients who had been planned to use supraglottic device from the beginning. | |||
Target sample size | 12000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe city medical center general hospital | ||||||
Division name | Department of anesthesiology | ||||||
Zip code | |||||||
Address | Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan | ||||||
TEL | 078-302-4321 | ||||||
cantateveritas@kcho.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe city medical center general hospital | ||||||
Division name | Department of anesthesiology | ||||||
Zip code | |||||||
Address | Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan | ||||||
TEL | 078-302-4321 | ||||||
Homepage URL | |||||||
cantateveritas@kcho.jp |
Sponsor | |
Institute | Kobe city medical center general hospital, Department of anesthesiology |
Institute | |
Department |
Funding Source | |
Organization | no fund |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 | 神戸市立医療センター中央市民病院(兵庫県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | risk factors of difficult mask ventilation and difficult intubation were identified: male,age>51,bmi>25,snoring,osas,receding mandibular,neck flexion restricted. |
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 | Main results already published | ||||||
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Other | |
Other related information | Main results were presented at Japan Society of Anesthesiology annual meeting, 2015. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020604 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |