UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
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	Main results already published
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	2022 Year 02 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044604