UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039461 |
|---|---|
| Receipt number | R000044796 |
| Scientific Title | Conservative versus liberal oxygenation targets in patients undergoing one-lung ventilation during thoracic surgery for lung resection: A Pilot single-center randomized controlled trial |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/12/17 22:54:14 |
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Basic information
Public title
Conservative versus liberal oxygenation targets in patients undergoing one-lung ventilation during thoracic surgery for lung resection: A Pilot single-center randomized controlled trial
Acronym
Conservative versus liberal oxygenation targets in patients undergoing one-lung ventilation
Scientific Title
Conservative versus liberal oxygenation targets in patients undergoing one-lung ventilation during thoracic surgery for lung resection: A Pilot single-center randomized controlled trial
Scientific Title:Acronym
Conservative versus liberal oxygenation targets in patients undergoing one-lung ventilation
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the efficacy and safety of conservative oxygen therapy in patients undergoing one-lung ventilation during thoracic surgery for lung resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiological atelectasis score of the dependent lung just after surgery
Key secondary outcomes
*Radiological atelectasis score of the dependent lung on postoperative day (POD)1
*PaO2/FIO2 ratio just after surgery and on POD1
*Time-weighted average of SpO2 and FIO2 during surgery
*Sequential Organ Failure Assessment (SOFA) score on POD1 and POD2
*Postoperative complications within 7 days following surgery (Clavien-Dindo classification grade =>III)
*AKI within 2 days following surgery (defined using KDIGO creatinine criteria)
*Hospital-free days at 28 days
*Hypoxemia during surgery (SpO2 <88% continues for more than 2min)
*Severe hypoxemia during surgery (SpO2 =<85% continues for more than 2min)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
Conservative group (Intervention)
Target oxygen saturation as measured by pulse oximetry (SpO2) of 90-94% during surgery
Interventions/Control_2
Liberal group (Control)
Target oxygen saturation as measured by pulse oximetry (SpO2) =>96% during surgery
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
1. Undergoing thoracic surgery for lung resection
2. Undergoing one-lung ventilation during general anesthesia
3. Adult aged 20 years or greater
4. Giving informed consent
Key exclusion criteria
1. Bilateral lung resection
2. Receiving surgery with one-lung ventilation during the past one month
3. Estimated surgery time <2 hours
4. ASA physical status =>4
5. Known chronic obstructive pulmonary disease
6. Urgent or time-critical surgery
7. Severe anemia (hemoglobin <8 g/dL)
8. Judged inappropriate for participation by the researchers
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morimatsu |
Organization
Okayama University, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7324
morima-h@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Suzuki |
Organization
Okayama University Hospital
Division name
Department of Intensive Care
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7330
Homepage URL
suzuki-s@mtc.biglobe.ne.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
Tel
086-235-7361
ouh-crrb@adm.okayama-u.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
岡山大学病院（岡山県）
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Delay in recruiting first patient due to COVID-19.
Open for patient enrollment on 9 December 2022.
Management information
Registered date
| 2020 | Year | 02 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044796
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