UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014849 |
|---|---|
| Receipt number | R000017256 |
| Scientific Title | Reduction in intensity of postoperative sore throat after nasotracheal intubation using a fiberoptic laryngoscope than Macintosh laryngoscopes: a double-blinded, randomized controlled study. |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2014/08/12 18:15:56 |
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Basic information
Public title
Reduction in intensity of postoperative sore throat after nasotracheal intubation using a fiberoptic laryngoscope than Macintosh laryngoscopes: a double-blinded, randomized controlled study.
Acronym
Reduction in intensity of postoperative sore throat after nasotracheal intubation using a fiberoptic laryngoscope.
Scientific Title
Reduction in intensity of postoperative sore throat after nasotracheal intubation using a fiberoptic laryngoscope than Macintosh laryngoscopes: a double-blinded, randomized controlled study.
Scientific Title:Acronym
Reduction in intensity of postoperative sore throat after nasotracheal intubation using a fiberoptic laryngoscope.
Region
| Japan |
Condition
Condition
Patients scheduled for elective general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether nasotracheal intubation using fiberoptic laryngoscope reduce postoperative sore throat compared with Macintosh laryngoscopes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative sore throat
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients scheduled for nasotracheal intubation using fiberoptic laryngoscope
Interventions/Control_2
Patients scheduled for nasotracheal intubation using Macintosh laryngoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ASA physical status I-II
Key exclusion criteria
Patients who had cardiac,hepatic or neurologic impairment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1W16, chu-o-ku, Sapporo
TEL
011-611-2111
niiyama@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuko Tachibana |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1W16, chu-o-ku, Sapporo
TEL
011-611-2111
Homepage URL
n.tachibana@sapmed.ac.jp
Sponsor or person
Institute
sapporo medical university school of medicine, department of anesthesiology
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
| 2014 | Year | 08 | Month | 20 | 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
| 2012 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 19 | 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
| 2014 | Year | 08 | Month | 12 | Day |
Last modified on
| 2014 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017256
