UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039987 |
|---|---|
| Receipt number | R000044604 |
| Scientific Title | New method for estimating post-extubation laryngeal edema |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2022/02/03 18:57:22 |
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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
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
toq7gknt6@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044604
