UMIN-CTR Clinical Trial

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
Email	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
Email	yamansavci@gmail.com

Sponsor
Institute	MARMARA UNIVERSITY
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043390