UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012102 |
|---|---|
| Receipt number | 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 20:18:28 |
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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
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
soichiyamashita@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Faculty of medicine, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014144
