UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038068 |
|---|---|
| Receipt number | R000043390 |
| Scientific Title | Oxygen reserve index guided oxygen titration in one lung ventilation |
| Date of disclosure of the study information | 2019/09/27 |
| Last modified on | 2019/09/27 15:09:57 |
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Basic information
Public title
Oxygen Titration Guided by Oxygen Reserve Index in Lung Surgery
Acronym
Oxygen Titration Guided by Oxygen Reserve Index in Lung Surgery
Scientific Title
Oxygen reserve index guided oxygen titration in one lung ventilation
Scientific Title:Acronym
Oxygen reserve index guided oxygen titration in one lung ventilation
Region
| Europe |
Condition
Condition
Lung surgery
Classification by specialty
| Chest surgery | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to reveal that we may protect the patient from the harmful effects of hyperoxia guided by ORI monitorization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome of this study is to determine the presence of hyperoxemia in patients undergoing low-flow anesthesia during OLV
Key secondary outcomes
The secondary outcome is to follow PaO2 trend noninvasively and to detect the hypoxemia before the reflection of SpO2.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In Group 1 (n = 30), during the OLV period, oxygen titration will be applied according to SpO2 and PaO2 without ORI during normal flow anesthesia with 4 L/min O2 flow
Interventions/Control_2
In addition to the standard follow-up parameters in Group 2 (n = 30), ORI, SpHb, Peak Variable Index (PVI), Perfusion Index (PI) and SpOc (oxygen contour) will be continuously monitored noninvasively and oxygen will be titrated using ORI and SpOc values during normal flow anesthesia with 4 L/min O2 flow
Interventions/Control_3
In Group 3 (n = 30), during the OLV period, oxygen titration will be applied according to SpO2 and PaO2 without ORI during lowl flow anesthesia with 1 L/min O2 flow
Interventions/Control_4
In addition to the standard follow-up parameters in Group 4 (n = 30), ORI, SpHb, Peak Variable Index (PVI), Perfusion Index (PI) and SpOc (oxygen contour) will be continuously monitored noninvasively and oxygen will be titrated using ORI and SpOc values during low flow anesthesia with 1 L/min O2 flow
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Video-asisted Lung Surgery
Key exclusion criteria
One-lung ventilation
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ayten |
| Middle name | |
| Last name | SARACOGLU |
Organization
MARMARA UNIVERSITY MEDICAL SCHOOL
Division name
Anesthesiology and Reanimation
Zip code
34899
Address
Fevzi Cakmak Mah. Muhsin Yazicioglu Cad. No:10 Pendik / Istanbul / Turkey
TEL
+905377810144
anesthesiayten@gmail.com
Public contact
Name of contact person
| 1st name | Esra |
| Middle name | |
| Last name | Yamansavci |
Organization
MARMARA UNIVERSITY MEDICAL SCHOOL
Division name
THORACIC SURGERY
Zip code
34899
Address
Fevzi Cakmak Mah. Muhsin Yazicioglu Cad. No:10 Ustkaynarca/ Pendik / Istanbul / Turkey
TEL
+905058723105
Homepage URL
yamansavci@gmail.com
Sponsor or person
Institute
MARMARA UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Marmara University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
TURKEY
Other related organizations
Co-sponsor
NONE
Name of secondary funder(s)
NONE
IRB Contact (For public release)
Organization
MARMARA UNIVERSITY SCIENTIFIC PROJECT SUPPORT DEPARTMENT
Address
Goztepe Kampusu 34722 / Kadikoy - Istanbul
Tel
+90 216 421 22 22
marmaraetikkurul@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
09.2018.141
Org. issuing International ID_1
09.2018.141
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Fevzi Cakmak Mah. Muhsin Yazicioglu Cad. No:10 Pendik / Istanbul / Turkey
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 27 | 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
120
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 20 | Day |
Last modified on
| 2019 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043390
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