UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019913 |
|---|---|
| Receipt number | R000008413 |
| Scientific Title | Assessment of airway changes after general anesthesia |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2024/11/30 09:10:04 |
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Basic information
Public title
Assessment of airway changes after general anesthesia
Acronym
Effects of general anesthesia on airway
Scientific Title
Assessment of airway changes after general anesthesia
Scientific Title:Acronym
Effects of general anesthesia on airway
Region
| Japan |
Condition
Condition
Surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether airway changes can occur during general anesthesia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Airway changes
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Surgical patients under general anesthesia
Key exclusion criteria
Patients who are pregnant or have upper airway pathology, cervical spine fractures, full stomach, or a history of difficult laryngoscopy or intubation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoki |
| Middle name | |
| Last name | Inoue |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
seninoue@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoki i |
| Middle name | |
| Last name | Inoue |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
Homepage URL
seninoue@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
IRB, Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara, 634-8521, Japan Nara Medical University
Tel
+81744223051
seninoue@naramed-u.ac.jp
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
| 2015 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Airway is evaluated with acoustic reflection, ultrasound quantification, neck circumference, and Modified Mallampati Score before and after general anesthesia.
Management information
Registered date
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008413
