UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035767 |
|---|---|
| Receipt number | R000035709 |
| Scientific Title | Usefulness of the pediatric endotracheal tube with a high-volume low-pressure cuff: a single center retrospective cohort study |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/02/04 15:07:11 |
* 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
Usefulness of the pediatric endotracheal tube with a high-volume low-pressure cuff: a single center retrospective cohort study
Acronym
Usefulness of the pediatric endotracheal tube with a high-volume low-pressure cuff: a single center study
Scientific Title
Usefulness of the pediatric endotracheal tube with a high-volume low-pressure cuff: a single center retrospective cohort study
Scientific Title:Acronym
Usefulness of the pediatric endotracheal tube with a high-volume low-pressure cuff: a single center study
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In our hospital, we have begun to use Microcuff PET (Pediatric Endotracheal Tube),endotracheal tube with a cuff specially designed for children, from August 2016. Because there have been little reports about the usefulness of the tube in Japanese children, we have conducted a retrospective cohort study to elucidate its usefulness and frequency of complications compared with the conventional cuffless tube.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of tube exchange ratio between the two groups.
Key secondary outcomes
Identification of the risk factors for exchange of the endotracheal tube.
The difference of the incidence of perioperative complications.
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
| 2 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients aged between 2 and 8 year-old who underwent general anesthesia with tracheal intubation (ASA PS 1-2) for surgery in supine or lateral position.
Key exclusion criteria
Difficult airway case.
The patients who were intubated cuffed tube other than the Microcuff PET.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Funai |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-2186
yusuke.funai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Funai |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-2186
Homepage URL
yusuke.funai@gmail.com
Sponsor or person
Institute
Osaka City University Graduate School of Medicine, Anesthesiology
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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
250 patients were included. Because 40 patients were excluded, 210 patients were analyzed. 127 patients were intubated uncuffed endotracheal tube (UC group) and 83 were intubated Microcuff tube (MC group). The tube exchange ratio was significantly low in MC group (UC 30 cases vs MC 1 case, p<0.001). In multiple regression analysis, the use of Microcuff tube is significant independent negative risk factor of tube exchange(odds ratio: 0.0408, 95%CI: 0.007-0.466, p=0.002). There was no significant difference between both groups in postoperative complications.
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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There was no case of complication or harmful event in all patients.
Management information
Registered date
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035709
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
