UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021118 |
|---|---|
| Receipt number | R000024369 |
| Scientific Title | Adjustment of inspired oxygen concentration during general anesthesia using Oxygen Reserve Index (ORI) a new parameter of oxygenation reserve potential. |
| Date of disclosure of the study information | 2016/02/21 |
| Last modified on | 2019/07/21 00:02:27 |
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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
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
masui@fmu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024369
