UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012130 |
|---|---|
| Receipt number | R000014183 |
| Scientific Title | Safety of nasotracheal intubation of the infants with difficult airway |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2015/04/30 14:23:47 |
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Basic information
Public title
Safety of nasotracheal intubation of the infants with difficult airway
Acronym
Nasotracheal intubation of the infants with difficult airway
Scientific Title
Safety of nasotracheal intubation of the infants with difficult airway
Scientific Title:Acronym
Nasotracheal intubation of the infants with difficult airway
Region
| Japan |
Condition
Condition
difficult airway
Classification by specialty
| Anesthesiology | Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When the infants with difficult airway were underwent anesthesia induction, safety of airway management methods and efficacy of the devices were evaluated.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety of airway management methods
Key secondary outcomes
Efficacy of the devices for airway management
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
| 0 | years-old | <= |
Age-upper limit
| 2 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants with difficult airway
Key exclusion criteria
Infants without difficult airway
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinari MORIMOTO |
Organization
Osaka University Dental Hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamada-oka, Suita, 565-0871, Japan
TEL
06-6879-2972
ysn-mori@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinari MORIMOTO |
Organization
Osaka University Dental Hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamada-oka, Suita, 565-0871, Japan
TEL
06-6879-2972
Homepage URL
https://hospital.dent.osaka-u.ac.jp/
ysn-mori@dent.osaka-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology, Osaka University Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Dental Anesthesiology, Osaka University Dental Hospital
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
| 2013 | Year | 11 | 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 | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 19 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 26 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 26 | Day |
Other
Other related information
The patient's records were retrospectively surveyed, the following items were examined: patient age, gender, height, weight, size of tracheal tube, operation and anesthesia time. Furthermore, method of anesthesia induction and airway management, used devices (intubation mask, video laryngoscope, etc), necessity of postoperative airway support, and airway management at the next operation.
Management information
Registered date
| 2013 | Year | 10 | Month | 26 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014183
