UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012706 |
|---|---|
| Receipt number | R000014842 |
| Scientific Title | Changes in the uncuffed endotracheal tube leak during laparoscopic surgery in children |
| Date of disclosure of the study information | 2013/12/27 |
| Last modified on | 2015/05/10 16:06:36 |
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Basic information
Public title
Changes in the uncuffed endotracheal tube leak during laparoscopic surgery in children
Acronym
Changes in the uncuffed endotracheal tube leak during laparoscopic surgery in children
Scientific Title
Changes in the uncuffed endotracheal tube leak during laparoscopic surgery in children
Scientific Title:Acronym
Changes in the uncuffed endotracheal tube leak during laparoscopic surgery in children
Region
| Japan |
Condition
Condition
Children planed to be performed laparoscopic abdominal surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure parameters about the endotracheal tube leak over time while mechanical ventilation in operating room.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endotracheal tube leak (Fractional volume loss)
Key secondary outcomes
Minimum airway pressure at which the audible air leak occurrs
Respiratory mechanics
Base
Study type
Observational
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
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) under 6 years old
2) more than 100 ml of tidal volume during mechanical ventilation
3) patients planed to be performed laparoscopic abdominal surgery with head-down tilt
4) written informed consent from parents
Key exclusion criteria
1) heart and respiratory disease
2) acute upper respiratory infection symptom
3) within 34 weeks for gestational ages
4) allergic history to any drug used in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Noguchi |
Organization
Saga University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
5-1-1 Nabeshima,Saga-shi,Saga
TEL
0952-34-2324
13624018@edu.cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Noguchi |
Organization
Saga University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
5-1-1 Nabeshima,Saga-shi,Saga
TEL
0952-34-2324
Homepage URL
13624018@edu.cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine,Saga University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
佐賀県医療センター好生館(佐賀県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 27 | 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
| 2013 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 29 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 29 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 07 | Day |
Other
Other related information
Nothing in particular
Management information
Registered date
| 2013 | Year | 12 | Month | 26 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014842
