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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039987
Receipt No. R000044604
Scientific Title New method for estimating post-extubation laryngeal edema
Date of disclosure of the study information 2020/03/31
Last modified on 2020/04/24

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Basic information
Public title New method for estimating post-extubation laryngeal edema
Acronym New method for estimating post-extubation laryngeal edema
Scientific Title New method for estimating post-extubation laryngeal edema
Scientific Title:Acronym New method for estimating post-extubation laryngeal edema
Region
Japan

Condition
Condition Patients on ventilator
Classification by specialty
Pneumology Anesthesiology Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of airway patency before extubation without cuff-leak test
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between cuff-leak test and subglottic leak pressure.
Key secondary outcomes patient-ventilator asynchrony, cough on examination, post-extubation stridor, post-extubation laryngeal edema, re-intubation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Measurement of subglottic leak pressure
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
10 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients on mechanical ventilation with subglottic secretion drainage endotracheal tubes
Key exclusion criteria 1) The patients with delirium.
2) The patients with mechanical circulatory support.
3)The patients who are judged to be inappropriate for this study by the attending physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Tokunaga
Organization Kumamoto University Hospital
Division name Department of Intensive Care Medicine
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan
TEL 096-373-7031
Email toq7gknt6@kuh.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Tokunaga
Organization Kumamoto University Hosipital
Division name Department of Intensive Care Medicine
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan
TEL 096-373-7031
Homepage URL
Email toq7gknt6@kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization No
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 Ethical Commity, Kumamoto University
Address 1-1-1 Honjo, Kumamoto City, Kumamoto, Japan
Tel 096-373-5657
Email ski-shien@jimu.kumamoto-u.ac.jp

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
2020 Year 03 Month 31 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 Enrolling by invitation
Date of protocol fixation
2020 Year 03 Month 31 Day
Date of IRB
2020 Year 04 Month 01 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 30 Day
Last modified on
2020 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044604

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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