UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053145 |
|---|---|
| Receipt number | R000060550 |
| Scientific Title | A prospective, single-blind, randomized clinical trial to evaluate the effectiveness of a new design of endotracheal suction catheter in reducing mucosal damage |
| Date of disclosure of the study information | 2023/12/19 |
| Last modified on | 2024/01/08 19:02:51 |
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Basic information
Public title
A prospective, single-blind, randomized clinical trial to evaluate the effectiveness of a new design of endotracheal suction catheter in reducing mucosal damage
Acronym
The effectiveness of a new design of endotracheal suction catheter in reducing mucosal damage
Scientific Title
A prospective, single-blind, randomized clinical trial to evaluate the effectiveness of a new design of endotracheal suction catheter in reducing mucosal damage
Scientific Title:Acronym
The effectiveness of a new design of endotracheal suction catheter in reducing mucosal damage
Region
| Asia(except Japan) |
Condition
Condition
Tracheal suction catheter
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We would like to identify newly designed tracheal suction catheter with a soft shape at the tip cause lesser endotracheal mucosal injury and other related side effects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tracheal injury grade
Key secondary outcomes
- the number of endotracheal suction
- vital signs before and after endotracheal suction (mean blood pressure, heart rate, SpO2)
- the occurrence of bloody secretion when endotracheal suction is done
- the satisfaction score about the function of endotracheal suction catheter (numerical rating scale from 0 to 10; 0-very unsatisfied, 10-very satisfied)
- the score of sore throat during 24 hours after surgery (numerical rating scale from 0 to 10; 0-no pain, 10-pain to death)
- the dose of opioid use during 24 hours after surgery
- Other respiratory complications (e.g. hemoptysis, increase of secretion)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A conventional endotracheal suction catheter with a sharp tip is used during lung surgery under one lung ventilation by using double lumen endotracheal tube
Interventions/Control_2
A novel endotracheal suction catheter with a soft tip is used during lung surgery under one lung ventilation by using double lumen endotracheal tube
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
| 19 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients receive lung surgery under general anesthesia who need double lumen endotracheal tube for one lung ventilation
Key exclusion criteria
- American Society of Anesthesiologists class > III
- Patients taking antiplatelet and/or anticoagulation drugs
- Patients who have abnormal coagulation lab (e.g. INR, PT, aPTT, platelet count)
- Patients who have active respiratory infection (e.g. pneumonia)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
TEL
82-31-787-7499
jinul8282@gmail.com
Public contact
Name of contact person
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
TEL
82-31-787-7509
Homepage URL
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
INSUNG medical Co., Ltd
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul National University Bundang Hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel
82-31-787-8801
snubhirb@gmail.com
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
| 2023 | Year | 12 | Month | 19 | 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
100
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
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060550
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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