UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010644 |
|---|---|
| Receipt number | R000012443 |
| Scientific Title | Comparison of usefulness of Airway scope guided nasotracheal intubation with conventional Macintosh laryngoscope in clinical study |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2015/05/13 09:15:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study
Acronym
Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study
Scientific Title
Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study
Scientific Title:Acronym
Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study
Region
| Japan |
Condition
Condition
oral surgery
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the usefulness of Airway scope during nasotracheal intubation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the time to nasotracheal intubation, the number of nasotracheal intubation, hemodynamic change during nasotracheal intubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Machintosh laryngoscope
Interventions/Control_2
Airway scope
Interventions/Control_3
McGRATH-MAC
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients with ASA physical status 1 and 2, aged 20 to 80 years old, who were scheduled to undergo oral surgery and general anesthesia by nasotracheal intubation
Key exclusion criteria
the patients who rejected for the administration of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of anesthesiology
Zip code
Address
South-1 West-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of anesthesiology
Zip code
Address
South 1, East 16, chuoku, Sapporo
TEL
011-611-2111
Homepage URL
edanaka@sapmed.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Sapporo Medical University School of Medicine
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 | 05 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | 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 | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012443
