UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031152 |
|---|---|
| Receipt number | R000035475 |
| Scientific Title | Comparative strength of noxious stimuli estimated by skin vasomotor reflex during laryngoscopy using Macintosh- or video-layngoscope |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2019/05/22 20:32:27 |
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Basic information
Public title
Comparative strength of noxious stimuli estimated by skin vasomotor reflex during laryngoscopy using Macintosh- or video-layngoscope
Acronym
Comparative strength of noxious stimuli during laryngoscopy using Macintosh- or video-layngoscope.
Scientific Title
Comparative strength of noxious stimuli estimated by skin vasomotor reflex during laryngoscopy using Macintosh- or video-layngoscope
Scientific Title:Acronym
Comparative strength of noxious stimuli during laryngoscopy using Macintosh- or video-layngoscope.
Region
| Japan |
Condition
Condition
surgical patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare strength of the skin vasomotor reflex during laryngoscopy using Macintosh- or video-laryngoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin blood flow before and after laryngoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
laryngoscopy with Macintosh laryngoscope
Interventions/Control_2
laryngoscopy with videolaryngocsopy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ASA classification 1-3
Patients consented to attend in this study
Key exclusion criteria
Patients with ASA classification 4-6
Patients predicted difficult airway
Patients with cardiovascular diseases
Patients with autonomic neuropathy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Kitajima |
Organization
Nihon University Itabashi Hospital
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL
0339728111
kitajima.osamu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Kitajima |
Organization
Nihon University Itabashi Hospital
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL
0339728111
Homepage URL
kitajima.osamu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Nihon University Itabashi Hospital
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
Tel
0339728111
med.itabashi.chiken@nihon-u.ac.jp
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
| 2018 | Year | 02 | Month | 05 | 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
20
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
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035475
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/05/22 | 喉頭鏡実施計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
