UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036120 |
|---|---|
| Receipt number | R000041148 |
| Scientific Title | Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation |
| Date of disclosure of the study information | 2019/03/07 |
| Last modified on | 2019/03/07 21:24:22 |
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Basic information
Public title
Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Acronym
Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Scientific Title
Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Scientific Title:Acronym
Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Region
| Japan |
Condition
Condition
Patients scheduled to undergo elective surgery requireing asleep nasotracheal intubation
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performing different methods of nasal intubation, we will compare whether there will be a difference in nasal bleeding or postoperative sore throat.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of nasal bleeding
Degree of sore throat
Degree of resistance in nasal passage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Rhinoscope-guided nasotracheal intubation
Interventions/Control_2
Blind nasal passage without any device.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia
Key exclusion criteria
bleeding disorder
abnormal nasal cavity
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiaki Nemoto |
Organization
Ohara general hospital
Division name
Department of anesthesiology
Zip code
Address
6-1 Uwamachi Fukushima-city Fukushima
TEL
024-526-0300
hippo_hipp0@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Mogami |
Organization
Ohara general hospital
Division name
Department of anesthesiology
Zip code
Address
6-1 Uwamachi Fukushima-city Fukushima
TEL
024-526-0300
Homepage URL
contralt.inutaro@gmail.com
Sponsor or person
Institute
Ohara general hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2019 | Year | 03 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 07 | 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
| 2019 | Year | 03 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041148
