UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058141 |
|---|---|
| Receipt number | R000066455 |
| Scientific Title | Evaluation of oxygenation reserve using Oxygen Reserve Index in differential lung ventilation with Nitric Oxide |
| Date of disclosure of the study information | 2025/06/11 |
| Last modified on | 2025/06/10 16:08:28 |
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Basic information
Public title
Evaluation of oxygenation reserve using Oxygen Reserve Index in differential lung ventilation with Nitric Oxide
Acronym
Examination of the effect of nitric oxide during differential lung ventilation by ORi
Scientific Title
Evaluation of oxygenation reserve using Oxygen Reserve Index in differential lung ventilation with Nitric Oxide
Scientific Title:Acronym
Examination of the effect of nitric oxide during differential lung ventilation by ORi
Region
| Japan |
Condition
Condition
Patients undergoing Minimally Invasive Cardiac Surgery requiring differential lung ventilation management with nitric oxide
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nitric oxide is used to improve oxygenation by decreasing pulmonary vascular resistance on the ventilatory side during Minimally Invasive Cardiac Surgery that requires differential lung ventilation. The Oxygen Reserve Index, which has recently been introduced to monitor oxygenation under hyperoxic conditions, is used to noninvasively evaluate the degree of improvement in oxygenation during differential lung ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: change in ORi due to nitric oxide
Secondary outcome: changes in biometric data (oxygen saturation) and arterial blood gas analysis (arterial blood partial pressure of oxygen)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who will undergo Minimally Invasive Cardiac Surgery using differential lung ventilation with nitric oxide at the Department of Surgery, Kyushu University Hospital from the date of study approval to December 31, 2025 (A.D.)
(2) Patients who fully understand this research plan and are able to give their (or their surrogate's) consent.
(3) Patients who are at least 18 years of age at the time consent is obtained.
Key exclusion criteria
(1) Patients for whom data extraction is impossible due to insufficient entries in the medical record.
(2) Other patients whom the investigator deems inappropriate as research subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Yamaura |
Organization
Kyushu University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5714
yamaura.ken.361@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Sakimura |
Organization
Kyushu University Hospital
Division name
Operating Rooms
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5714
Homepage URL
sakimura.shotaro.439@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
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
Kyushu University Hospital Institutional Review Board
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5858
tr-info@med.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066455
