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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012102
Receipt No. R000014144
Scientific Title Efficacy of transillumination method in appropriate tracheal tube placement in small children: A randomized clinical trial
Date of disclosure of the study information 2013/10/22
Last modified on 2013/10/22

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Basic information
Public title Efficacy of transillumination method in appropriate tracheal tube placement in small children: A randomized clinical trial
Acronym Tube depth by transillumination in small children
Scientific Title Efficacy of transillumination method in appropriate tracheal tube placement in small children: A randomized clinical trial
Scientific Title:Acronym Tube depth by transillumination in small children
Region
Japan

Condition
Condition All conditions scheduled for elective surgery in small children
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objective was to evaluate whether the transillumination method was superior to the mainstem method in appropriate TT placement in small children aged less than 2 years old undergoing general anesthesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The probability of appropriate TT placement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 In the transillumination group, after tracheal intubation, the ventilator circuit was disconnected from the TT, and an appropriate size of the Trachlight without the rigid inner stylet, a child size for 4.0 and 4.5 mm ID TT and an infant size for 3.0 and 3.5 mm ID TT, was inserted into the TT. The centimeter marks of the TT and the Trachlight were brought into line, thus positioning the light bulb of the Trachlight at the TT tip. After turning on the light, the TT position was considered to be appropriate when the transmitted light just became visible at the suprasternal notch.
Interventions/Control_2 In the mainstem group, after tracheal intubation, the TT was gently advanced until breath sounds over the left anterior chest wall were diminished. The TT was then gradually withdrawn until bilateral breath sounds returned. The centimeter marking on the TT at the alveolar ridge corresponding to the return of breath sounds was noted. The TT was then withdrawn an additional 2 cm and secured with the appropriate centimeter mark at the alveolar ridge.
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
2 years-old >
Gender Male and Female
Key inclusion criteria The patient population consisted of small children aged less than 2 years old scheduled for elective surgery, which needed chest radiography during or after surgery, undergoing general anesthesia
Key exclusion criteria Patients were excluded if they had congenital airway abnormalities, tracheal stenosis, trachomalacia, lung disease, or had already been intubated or tracheostomized.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamashita, Soichiro
Organization University of tsukuba
Division name Department of Anesthesiology, Faculty of Medicine
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL +81-29-853-3092
Email soichiyamashita@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamashita, Soichiro
Organization University of tsukuba
Division name Department of Anesthesiology, Faculty of Medicine
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL +81-29-853-3092
Homepage URL
Email soichiyamashita@md.tsukuba.ac.jp

Sponsor
Institute Department of anesthesiology, Faculty of medicine, University of Tsukuba
Institute
Department

Funding Source
Organization none
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
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 10 Month 22 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
2009 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 04 Month 30 Day
Date of closure to data entry
2011 Year 05 Month 26 Day
Date trial data considered complete
2011 Year 05 Month 26 Day
Date analysis concluded
2012 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 22 Day
Last modified on
2013 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014144

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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