UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040204 |
|---|---|
| Receipt number | R000045661 |
| Scientific Title | Evaluation of the effectiveness of automatic pressure controller (Smart Cuff) for displacement of endotracheal tube in thoracic surgery. |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2022/04/22 12:48:12 |
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Basic information
Public title
Evaluation of the effectiveness of automatic pressure controller (Smart Cuff) for displacement of endotracheal tube in thoracic surgery.
Acronym
Evaluation of the effectiveness of automatic pressure controller (Smart Cuff) for displacement of endotracheal tube in thoracic surgery.
Scientific Title
Evaluation of the effectiveness of automatic pressure controller (Smart Cuff) for displacement of endotracheal tube in thoracic surgery.
Scientific Title:Acronym
Evaluation of the effectiveness of automatic pressure controller (Smart Cuff) for displacement of endotracheal tube in thoracic surgery.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of SmartCuff for reducing fluctuation of cuff pressure and preventing endotracheal tube displacement due to bronchial traction and retraction in thoracic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endotracheal tube displacement due to bronchial traction
Key secondary outcomes
Fluctuation of cuff pressure by bronchial traction
Changes in tidal volume due to bronchial traction
Preservation of one lung ventilation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing segmental or lobectomy with double-lumen endotracheal tube intubation in thoracic surgery
Key exclusion criteria
Patients with bronchoplasty
Patients with anatomical abnormalities in the trachea
Patients refused to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Tokinaga |
Organization
Sapporo Medical University of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
Sapporoshi Chuoku Mimami 1 jou Nishi 16 choume
TEL
011-611-2111
flybabrfr@live.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
Sapporoshi Chuoku Mimami 1 jou Nishi 16 choume
TEL
011-611-2111
Homepage URL
flybabrfr@live.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
Sapporo Medical University School of Medicine
Address
Sapporoshi Chuoku Mimami 1 jou Nishi 16 choume
Tel
011-611-2111
flybabrfr@live.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 | 04 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 27 | 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
none
Management information
Registered date
| 2020 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045661
