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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035767
Receipt No. 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

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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
Email 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
Email yusuke.funai@gmail.com

Sponsor
Institute Osaka City University Graduate School of Medicine, Anesthesiology
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 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
URL(English) https://upload.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


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