UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038676 |
|---|---|
| Receipt number | R000044064 |
| Scientific Title | Detection of esophageal intubation after intubation attempts with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study |
| Date of disclosure of the study information | 2019/11/26 |
| Last modified on | 2021/11/29 19:39:03 |
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Basic information
Public title
Detection of esophageal intubation with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study
Acronym
Detection of esophageal intubation after intubation attempts with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study
Scientific Title
Detection of esophageal intubation after intubation attempts with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study
Scientific Title:Acronym
Detection of esophageal intubation with the Macintosh laryngoscope and the video laryngoscope
Region
| Japan |
Condition
Condition
a standard and difficult airway manikin
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of the McGrath MAC video lar yngoscope and the Macintosh laryngoscope to distinguish between tracheal and esophageal placement of the tube in a standard and difficult airway manikin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
time for detection of the tube position
Key secondary outcomes
success rate of detection of true position,
frequency of dental damage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Macintosh laryngoscope
Interventions/Control_2
McGrath MAC video laryngoscope
Interventions/Control_3
a normal manikin
Interventions/Control_4
a difficult airway manikin
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
primary residents who had experienced more than 30 cases of tracheal intubation
Key exclusion criteria
without consent
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Aoyama |
Organization
Kitakyushu General Hospital
Division name
Department of Anesthesia
Zip code
802-8517
Address
1-1 Higashijono-machi, Kokurakit a-ku, Kitakyushu
TEL
093-921-0560
kazuyoshi.aoyama@kitakyu-hp.or.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Aoyama |
Organization
Kitakyushu General Hospital
Division name
Department of Anesthesia
Zip code
802-8517
Address
1-1 Higashijono-machi, Kokurakit a-ku, Kitakyushu
TEL
093-921-0560
Homepage URL
kazuyoshi.aoyama@kitakyu-hp.or.jp
Sponsor or person
Institute
Department of Anesthesia, Kitakyushu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia, Kitakyushu General Hospital
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
Ethics committee of Kitakyushu General H ospital
Address
1-1 Higashijono-machi, Kokurakita- ku, Kitakyushu
Tel
093-921-0560
yoshifumi.nakayama@kitakyu-hp.or.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
北九州総合病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 26 | 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
| 2019 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044064
