UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009862 |
|---|---|
| Receipt number | R000011556 |
| Scientific Title | The onset of nasal bleeding and intubation time by the laterality of the nasal cavity as the route of nasotracheal intubation. |
| Date of disclosure of the study information | 2013/01/25 |
| Last modified on | 2013/01/25 11:07:03 |
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Basic information
Public title
The onset of nasal bleeding and intubation time by the laterality of the nasal cavity as the route of nasotracheal intubation.
Acronym
Nasotracheal intubation and nasal blleding
Scientific Title
The onset of nasal bleeding and intubation time by the laterality of the nasal cavity as the route of nasotracheal intubation.
Scientific Title:Acronym
Nasotracheal intubation and nasal blleding
Region
| Japan |
Condition
Condition
Nasal bleeding
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When we perform nasotracheal intubation(NTI), it is necessary to insert a tracheal tube through the left or right nasal cavities. However, unless a clear stenosis of nasal cavity is found beforehand, it depends on an anesthesiologist whether to choose either left or right nasal cavity.
Therefore, we investigated the onset of nasal bleeding and intubation time by the laterality of the nasal cavity as the route of the NTI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the ratio of nasal bleeding
Key secondary outcomes
Evaluate the intubation time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Intubation through the right nasal cavity
Interventions/Control_2
Intubation through the left nasal cavity
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
| 16 | years-old | <= |
Age-upper limit
| 52 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Between the age 16 and 52 years old
American Society of Anesthesiologists Class 1 or 2
Key exclusion criteria
We ruled out the patients who had narrow nasal cavity previously and had medication likely to induce bleeding.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Boku Aiji |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamadaoka, Suita,Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamadaoka, Suita,Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Dentistry
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
| 2013 | Year | 01 | Month | 25 | 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
| 2011 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 08 | 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
| 2013 | Year | 01 | Month | 24 | Day |
Last modified on
| 2013 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011556
