UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026805 |
|---|---|
| Receipt number | R000030770 |
| Scientific Title | Study on the usefullness of Oxygen Reserve Index (ORI) in nasotracheal intubation using broncho-fiber scope |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/06/16 12:22:42 |
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Basic information
Public title
Study on the usefullness of Oxygen Reserve Index (ORI) in nasotracheal intubation using broncho-fiber scope
Acronym
Study on the usefullness of Oxygen Reserve Index (ORI) in nasotracheal intubation using broncho-fiber scope
Scientific Title
Study on the usefullness of Oxygen Reserve Index (ORI) in nasotracheal intubation using broncho-fiber scope
Scientific Title:Acronym
Study on the usefullness of Oxygen Reserve Index (ORI) in nasotracheal intubation using broncho-fiber scope
Region
| Japan |
Condition
Condition
intraoral lesion
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on the usefulness of Oxygen Reserve Index (ORI) in operation of nasal fiberoptic intubation in general anesthesia for oral surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time from beginning to decline the ORI level to begginig to decline SpO2 level
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
ASA-PS class 1 or 2.
Key exclusion criteria
Patients with respiratory disease, anemia gravis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yokoyama |
Organization
kyushu university
Division name
dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
yokoyama@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hirokawa |
Organization
kyushu university
Division name
dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
Homepage URL
hj8823@dent.kyushu-u.ac.jp
Sponsor or person
Institute
department of dental anesthesiology, kyushu university
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recoring the ORI level in operation of nasal fiberoptic intubation
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030770
