UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057068 |
|---|---|
| Receipt number | R000065228 |
| Scientific Title | Development of a Predictive Model for Oxygen Desaturation During One-Lung Ventilation Using Preoperative Data |
| Date of disclosure of the study information | 2025/02/26 |
| Last modified on | 2026/02/19 14:36:40 |
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Basic information
Public title
Development of a Predictive Model for Oxygen Desaturation During One-Lung Ventilation Using Preoperative Data
Acronym
Development of a Predictive Model for Oxygen Desaturation
Scientific Title
Development of a Predictive Model for Oxygen Desaturation During One-Lung Ventilation Using Preoperative Data
Scientific Title:Acronym
Development of a Predictive Model for Oxygen Desaturation
Region
| Japan |
Condition
Condition
Patients undergoing thoracic surgery with one-lung ventilation
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a machine-learning model to predict oxygen desaturation using preoperative data in patients undergoing thoracic surgery with one-lung ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The lowest percutaneous oxygen saturation recorded within the first hour after the initiation of one-lung ventilation.
Key secondary outcomes
Feature importance
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in this study underwent thoracic surgery with one-lung ventilation in the lateral decubitus position at the University of Toyama Hospital between January 1, 2020, and December 31, 2023. The target diseases included lung tumors, pneumothorax, and empyema.
Key exclusion criteria
Individuals who requested to opt out of the study after the publication of the information disclosure document. Patients who underwent bilateral lung surgery, those who required a right-sided one-lung ventilation tube, and those who used a bronchial blocker.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
Organization
Toyama University Hospital
Division name
Department of Anesthesiology
Zip code
9300194
Address
2630 Sugitani, Toyama, Japan
TEL
0764347377
takazawt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Hasegawa |
Organization
Toyama University Hospital
Division name
Intensive Care Unit
Zip code
9300194
Address
2630 Sugitani, Toyama, Japan
TEL
0764347377
Homepage URL
megahase@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Toyama University Hospital Center for Clinical and Translational Research
Address
2630 Sugitani, Toyama, Japan
Tel
0764347034
rinken@adm.u-toyama.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
| 2025 | Year | 02 | Month | 26 | 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
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2025 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065228
