UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017213 |
|---|---|
| Receipt number | R000019510 |
| Scientific Title | Cuffed vs uncuffed endtrachial tube - randomized controlled trial in pediatric patients younger than 6-year-old including neonates at single institute |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2016/12/27 14:46:58 |
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Basic information
Public title
Cuffed vs uncuffed endtrachial tube - randomized controlled trial in pediatric patients younger than 6-year-old including neonates at single institute
Acronym
Micro-SPA (Microcuff Suitable for Pediatric Anesthesia)
Scientific Title
Cuffed vs uncuffed endtrachial tube - randomized controlled trial in pediatric patients younger than 6-year-old including neonates at single institute
Scientific Title:Acronym
Micro-SPA (Microcuff Suitable for Pediatric Anesthesia)
Region
| Japan |
Condition
Condition
General anesthetized patients requiring endtracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of cuffed pediatric tracheal tube (Microcuff endtracheal tube) compared to uncuffed endtracheal tube in Japanese children (newborn - 6 years old)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Presence of inspiratory stridor after extubation in operation room and/or recovery room
Key secondary outcomes
1. Secondary outcomes
1) Tube exchange
2) Therapy for inspiratory stridor after extubation (nebulized epinephrine and/or continuous positive airway pressure)
3) Time from extubation to leaving recovery room
4) Impaired airway track due to intubation itself (laryngospasm and/or tracheal hemorrhage)
5) Re-intubation
6) Unexpected ICU-admission due to airway problems
7) Need for oxygen at the time of leaving recovery room
8) Residual inspiratory stridor at the time of leaving recovery room
2. Experimental endpoints
1) Accidental one lung ventilation
2) Adjustment of tube position after intubation
3) Reliability of EtCO2 wave
4) Need for fresh gas flow more than 4L/min
5) Adjustment of cuff pressure due to accidental change in cuff pressure (Group A)
6) Change in length of tube position more than or equal to 1 cm
7) Need for pharyngeal gauze packing
8) Inappropriate location of tube tip detected with chest X-ray
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: Intubate using cuffed tracheal tube (Microcuffe endotracheal tube / Halyard Healthcare, Inc.)
Interventions/Control_2
Control: Intubate using uncuffed tracheal tube (PORTEX endotracheal tube / Smiths Medical )
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
| 0 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Children who are undergoing elective surgery or examination requiring enrtracheal intubation under general anesthesia
2) Children with parental written informed consent
3) Children who are planed to extubabe in operation room, stay at recovery room until getting stable, and then go back to ward
4) Children from newborns to younger than 6 years of age (Newborns are required to be born at full-term of gestation and weight more than or equal to 3 kg.)
Key exclusion criteria
1) Children who are undergoing urgent or emergency surgery
2) Children who have impaired functions of airway and/or swallowing
3) Children who are known or predicted to have difficulty in airway management
4) Children who have upper respiratory infection within 2 weeks or lower respiratory infection within 4 weeks
5) Children who are undergoing surgical interventions into airway itself or lung (e.g. adenoidectomy)
6) Children who had been enrolled in this study
7) Children with severe general status (ASA PS >2)
Target sample size
1150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kogure |
Organization
National Center for Child Health and Development
Division name
Department of intensive care and anesthesia
Zip code
Address
2-10-1 Okura, Setagaya Tokyo 157-8535, JAPAN
TEL
+81-3-3416-0181
kogure-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kogure |
Organization
National Center for Child Health and Development
Division name
Department of intensive care and anesthesia
Zip code
Address
2-10-1 Okura, Setagaya Tokyo 157-8535, JAPAN
TEL
+81-3-3416-0181
Homepage URL
kogure-y@ncchd.go.jp
Sponsor or person
Institute
Department of intensive care and anesthesia, National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
No funding
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
国立成育医療研究センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019510
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/12/27 | Microcuff_SAP_002-2.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/12/27 | プロトコール確認登録シート_2015.4.21_YK.docx |
| Research case data | |
|---|---|
| Registered date | File name |
