UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045033 |
|---|---|
| Receipt number | R000051424 |
| Scientific Title | A study of the ideal endotracheal tube insertion length in children using the distance between the vocal cords and the carina tracheae |
| Date of disclosure of the study information | 2021/08/03 |
| Last modified on | 2021/08/02 11:55:53 |
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Basic information
Public title
A study of the ideal endotracheal tube insertion length in children using the distance between the vocal cords and the carina tracheae
Acronym
A study of the ideal endotracheal tube insertion length in children using the distance between the vocal cords and the carina tracheae
Scientific Title
A study of the ideal endotracheal tube insertion length in children using the distance between the vocal cords and the carina tracheae
Scientific Title:Acronym
A study of the ideal endotracheal tube insertion length in children using the distance between the vocal cords and the carina tracheae
Region
| Japan | Europe |
Condition
Condition
cardiac disease and non-cardiac disease
Classification by specialty
| Surgery in general | Vascular surgery | Pediatrics |
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Numerous formulas to predict endotracheal intubation depth at the mouth corner or nasal wing of patients have been reported. However, the oral and nasal cavity anatomies differ among patients. Therefore, the purpose of this study was to derive a simple and reliable formula to predict the ideal endotracheal tube (ETT) insertion depth at the vocal-cord level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The Outcome of this study was to derive a simple and reliable formula to predict the ideal endotracheal tube (ETT) insertion depth at the vocal-cord level.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The first-stage retrospective observational study enrolled cardiac paediatric patients in Germany, and cardiac and non-cardiac paediatric patients in Japan. The second-stage study was performed in paediatric and adult patients in Japan to verify the results of the first-stage study.
Key exclusion criteria
Nothing special
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
yamatomo270@hotmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
Homepage URL
yamatomo270@hotmail.com
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
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
Division of Anaesthesiology, Niigata University Graduate School of Medical and Dental Sciences
Address
1-757, Asahimachi-dori, Chuo ward, Niigata, 951-8510, Japan
Tel
+81252272328
yamatomo270@hotmail.com
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
| 2021 | Year | 08 | Month | 03 | 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
1343
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
| 2014 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The first-stage study enrolled 425 paediatric patients with congenital heart diseases who underwent cardiovascular surgeries between January 2015 and March 2018 at German Paediatric Heart Centre Sankt Augustin (Sankt Augustin, Germany) as well as 335 paediatric patients with congenital heart diseases who underwent cardiovascular surgeries and 275 paediatric patient who underwent non-cardiac paediatric surgeries between April 2010 and March 2020 at Niigata University Medical and Dental Hospital (Niigata, Japan).
A total of 132 paediatric patients with congenital heart diseases who underwent cardiovascular surgery, 14 paediatric patients without congenital heart diseases who underwent non-cardiac surgery, and 162 adult patients who underwent cardiac or non-cardiac surgery between April 2020 and May 2021 at Niigata University Medical and Dental Hospital were enrolled.
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051424
