UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010983
Receipt No. R000012816
Scientific Title Predictive formula for appropriate endotracheal tube size in preschool-age children
Date of disclosure of the study information 2013/06/17
Last modified on 2017/06/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Predictive formula for appropriate endotracheal tube size in preschool-age children
Acronym Predictive formula for appropriate endotracheal tube size in preschool-age children
Scientific Title Predictive formula for appropriate endotracheal tube size in preschool-age children
Scientific Title:Acronym Predictive formula for appropriate endotracheal tube size in preschool-age children
Region
Japan

Condition
Condition preshoool-age children in pediatric surgery such as inguinal hernia and cryptorchidism fusion in head and neck median fixed
Classification by specialty
Pediatrics Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cole formula used more than half a century dosen't work well now. We investigate the new formula with a lot of parameters.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Tubes were replaced as necessary until a good clinical fit was obtained. We seek the significant factors among a lot of parameters such as 1.month old, 2.height, 3.weight, 4.via chest X-ray photo,two tracheal diameters, 5.via ultrasonography, the subglottic upper airway diameter, 6.gestational age, 7.weight at birth.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To investigate the most relevant factors to decide an appropriate size of the tracheal tube during general anesthesia in children
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
1 years-old <=
Age-upper limit
7 years-old >=
Gender Male and Female
Key inclusion criteria Written consent is obtained
Head of the median position
supine position
Key exclusion criteria Severely retarded children
Positions other than supine
Positions after bending and forward bending of the head
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Oi Yumiko
Organization National Mie Hospital
Division name Anesthesiology
Zip code
Address Oosatokubota cho 357,Tsu city, Mie Pref.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Oi Yumiko
Organization National Mie Hospital
Division name Anesthesiology
Zip code
Address 059-232-2531
TEL
Homepage URL
Email

Sponsor
Institute National Mie Hospital
Institute
Department

Funding Source
Organization National Mie Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 06 Month 17 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 Enrolling by invitation
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 17 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.