UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039910 |
|---|---|
| Receipt number | R000045503 |
| Scientific Title | Assessments of clinical usefulness of a cuff-leak test for safe tracheal extubation: comparison before and after surgery |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/03/26 22:09:24 |
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Basic information
Public title
Assessments of clinical usefulness of a cuff-leak test for safe tracheal extubation: comparison before and after surgery
Acronym
clinical usefulness of cuff leak pressure
Scientific Title
Assessments of clinical usefulness of a cuff-leak test for safe tracheal extubation: comparison before and after surgery
Scientific Title:Acronym
clinical usefulness of cuff leak pressure
Region
| Japan |
Condition
Condition
Patients undergoing upper abdominal surgery and cervical spine surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery | Oto-rhino-laryngology | Orthopedics |
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test an hypothesis that cuff-leak pressure(CLP) increases after surgery (primary hypothesis) and reflects postoperative laryngeal edema assessed by endoscopic observation.
Basic objectives2
Others
Basic objectives -Others
To explore possible techniques assessing postoperative laryngeal edema.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cuff-leak pressure
Key secondary outcomes
vocal cord angle, cuff-leak volume, laryngeal edema score, upper airway ultrasound parameters, neck circumference, tissue elastance, tissue water contents, and so on
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
Measurements of cuff leak pressure before and after surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo general anesthesia for upper abdominal surgery or cervical spine surgery
Key exclusion criteria
1) Airway malformation
2) Severe respiratory disease: asthma,pneumonia
3) Severe cardiovascular disease: myocardial infarction
4) Intracranial lesion
5) During dialysis
6) Palatine tonsil hypertrophy(>Grade 3)
7) Severe nasal congestion
8) After head and neck surgery
9) After tracheostomy
10) Difficult intubation, Not applicable for extubation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shiroh |
| Middle name | |
| Last name | Isono |
Organization
Chiba University
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba
TEL
0432227171
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamada |
Organization
Chiba University
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba
TEL
0432227171
Homepage URL
tyamada.vn@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
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
Graduate school of medicine school of medicine, Chiba university
Address
1-8-1 Inohana Chuo Chiba
Tel
0432227171
igaku-rinri@office.chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
