UMIN-CTR Clinical Trial

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
Email	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
Email	yamatomo270@hotmail.com

Sponsor
Institute	Niigata University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051424