UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050844 |
|---|---|
| Receipt number | R000057920 |
| Scientific Title | Correlation between lung volume measured by preoperative computed tomography and lung collapse time during one lung ventilation: a prospective study |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2023/04/14 10:44:56 |
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Basic information
Public title
Correlation between lung volume measured by preoperative computed tomography and lung collapse time during one lung ventilation: a prospective study
Acronym
Correlation between lung volume and lung collapse time
Scientific Title
Correlation between lung volume measured by preoperative computed tomography and lung collapse time during one lung ventilation: a prospective study
Scientific Title:Acronym
Correlation between lung volume and lung collapse time
Region
| Asia(except Japan) |
Condition
Condition
Lung cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we would like to analyze the correlation between lung volume measured by chest computed tomography taken before surgery and lung collapse time during one lung ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung collapse time
Key secondary outcomes
Partial pressure of oxygen (PaO2), hypoxemia (SpO2 <95%) incidence, use of continuous positive airway pressure (CPAP)
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
| 19 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
American society of anesthesiologists physical status classification (ASA classification) I-III adult patients with lung cancer aged 18 years or older and 75 years or younger who undergo VATS surgery under one lung ventilation.
Key exclusion criteria
- American society of anesthesiologists physical status classification (ASA classification) >= IV
- age under 18 years old
- Pneumothorax or artificial pneumothorax
- Abnormal expiratory recoil (FEV1 <70%)
- Pleural adhesion expected during preoperative assessment
- Bullae on preoperative computed tomography scan
- Previous lung surgery
- Expected difficult intubation
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Ji Hyeon |
| Middle name | |
| Last name | Lee |
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, 13620, Republic of Korea
TEL
82-31-787-7499
dreamerwlgus@gmail.com
Public contact
Name of contact person
| 1st name | Ji Hyeon |
| Middle name | |
| Last name | Lee |
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, 13620, Republic of Korea
TEL
82-31-787-7499
Homepage URL
dreamerwlgus@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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
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 | 04 | Month | 14 | 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
58
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe lung collapse time after induction of one lung ventilation.
Then, we compare lung collapse time and the preoperative lung volume measured by using 3D work station.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057920
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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