UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040496 |
|---|---|
| Receipt number | R000046019 |
| Scientific Title | Effect of a barrier enclosure on tracheal intubation difficulty |
| Date of disclosure of the study information | 2020/05/25 |
| Last modified on | 2020/10/05 14:16:39 |
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Basic information
Public title
Effect of a barrier enclosure on tracheal intubation difficulty
Acronym
Effect of a barrier enclosure on tracheal intubation difficulty
Scientific Title
Effect of a barrier enclosure on tracheal intubation difficulty
Scientific Title:Acronym
Effect of a barrier enclosure on tracheal intubation difficulty
Region
| Japan |
Condition
Condition
An airway management simulator manikin
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study was to determine how the barrier enclosure affects tracheal intubation difficulty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes were the first-pass intubation success rate, time to successful tracheal intubation, Cormack-Lehane grade, percentage of glottic opening (POGO) score, peak force to maxillary incisors that was measured by force sensors attached to the manikin.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Tracheal intubation with an aerosol box using a direct laryngoscope
Interventions/Control_2
Tracheal intubation without an aerosol box using a direct laryngoscope
Interventions/Control_3
Tracheal intubation with an aerosol box using a McGRATH MAC videolaryngoscope
Interventions/Control_4
Tracheal intubation without an aerosol box using a McGRATH MAC videolaryngoscope
Interventions/Control_5
Tracheal intubation with an aerosol box using an airway scope AWS-S200NK videolaryngoscope
Interventions/Control_6
Tracheal intubation without an aerosol box using an airway scope AWS-S200NK videolaryngoscope
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
1. Experienced anesthetists who had performed more than 50 tracheal intubations using both a direct laryngoscope and a videolaryngoscope
2. Normal or corrected-to-normal eyesight
Key exclusion criteria
1. Who do not wish to participate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
+81263372670
waka0924@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
+81263372670
Homepage URL
waka0924@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee for Medical Ethics of Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
+81263372572
mdrinri@shinshu-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
| 2020 | Year | 05 | Month | 25 | 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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 22 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046019
