UMIN-CTR Clinical Trial

Basic information
Public title	Adjustment of inspired oxygen concentration during general anesthesia using Oxygen Reserve Index (ORI) a new parameter of oxygenation reserve potential.
Acronym	Adjustment of inspired oxygen concentration during general anesthesia using Oxygen Reserve Index (ORI) a new parameter of oxygenation reserve potential.
Scientific Title	Adjustment of inspired oxygen concentration during general anesthesia using Oxygen Reserve Index (ORI) a new parameter of oxygenation reserve potential.
Scientific Title:Acronym	Adjustment of inspired oxygen concentration during general anesthesia using Oxygen Reserve Index (ORI) a new parameter of oxygenation reserve potential.
Region	Japan

Condition
Condition	Patients with ASA (American Society of Anesthesiologists) classification 1 or 2 who are scheduled for surgical procedures under general anesthesia
Classification by specialty	Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the possibility of adjusting inspired oxygen concentrations during general anesthesia by monitoring the Oxygen Reserve Index (ORI), which indicates real-time oxygenation status (PaO2 of about 100-200 mmHg).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PaO2 obtained by arterial blood gas analysis, and the ORI and inspired oxygen concentration at the time of blood colection during general anesthesia
Key secondary outcomes	1. Basic information of patients: Gender, age, height, weight, date of surgery, diagnosis, operative procedure, sensor attachment site, and insertion site of the arterial pressure line. 2. Presence or absence of adverse events, symptoms, extent, and treatment. 3. Presence or absence of measurement equipment failure. 4. Presence or absence of measurement cessation. 5.Recording of data monitoring: Inspired oxygen concentration, arterial blood gas analysis, blood pressure, heart rate, SpO2, ORI, SpHb of RootTM, perfusion index (PI), and pleth variability index (PVI)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	To measure ORI, a sensor similar in form to a pulse oximeter sensor is applied to the third or fourth finger of each patient for a duration lasting from admission to the operating room until the end of surgery. In cases where the catheter insertion is required for blood pressure measurement for the surgery, the catheter is inserted into the artery after general anesthesia induction in the operating room. The inspired oxygen concentration is set to 33% after general anesthesia is stabilized. Then, arterial blood gas analysis is performed using 1 mL blood collected from the arterial pressure line, and the ORI at the blood collection is recorded. The inspired oxygen concentration is changed to achieve an ORI level of approximately 0.5 (expected PaO2 of approximately 150 mmHg), followed by arterial blood gas analysis and recording ORI. The inspired oxygen concentration is then changed again to achieve an ORI level of approximately 0.2 (expected PaO2 of 100 mmHg or more), followed by arterial blood gas analysis and recording ORI. If the PaO2 is less than 100 mmHg at this point, the study is terminated for the subject and the inspired oxygen concentration is returned to 33%. Otherwise, the inspired oxygen concentration is changed to achieve an ORI level of 0, followed by arterial blood gas analysis and recording of the ORI. The study is subsequently terminated for the subject and the inspired oxygen concentration is returned to optimum concentration.
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 who are scheduled for surgical procedures under general anesthesia, and who meet all of the following conditions: 1. ASA (American Society of Anesthesiologists) classification 1 or 2. 2. Submission of written informed consent for this study. 3. After general anesthesia induction at the operating room, a catheter for blood pressure measurement is inserted in the artery when necessary for the surgery.
Key exclusion criteria	Patients are excluded if they meet any of the following conditions: 1. Inability to wear the sensor due to deformity or hypoperfusion of fingers. 2. Preoperative anemia due to hemoglobinopathies (e.g. sickle cell disease, thalassemia) 3. Cardiac or pulmonary disease (e.g. chronic obstructive pulmonary disease, interstitial pneumonia) 4. Ineligibility for participation in the study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Murakawa
Organization	Fukushima Medical University
Division name	Department of Anesthesiology
Zip code	960-1295
Address	1 Hikariga-oka, Fukushima City, Fukushima Prefecture
TEL	024-547-1111
Email	masui@fmu.ac.jp

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Isosu
Organization	Fukushima Medical University
Division name	Department of Anesthesiology
Zip code	960-1295
Address	1 Hikariga-oka, Fukushima City, Fukushima Prefecture
TEL	024-547-1111
Homepage URL
Email	masui@fmu.ac.jp

Sponsor
Institute	Department of Anesthesiology, Fukushima Medical University
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Fukushima Medical University
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	Ethics Committee of Fukushima Medical University
Address	1 Hikariga-oka, Fukushima City, Fukushima Prefecture
Tel	024-547-1111
Email	rs@fmu.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	2016 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	DOI: 10.1007/s10877-019-00341-9
Number of participants that the trial has enrolled	20
Results	DOI: 10.1007/s10877-019-00341-9
Results date posted	2019 Year 07 Month 21 Day
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	2016 Year 01 Month 01 Day
Date of IRB	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 21 Day
Last modified on	2019 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024369