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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020983
Receipt No. R000024217
Scientific Title Usefulness of Oxygen Reserve Index (ORi), a new parameter of oxygenation reserve potential, for rapid sequence induction of general anesthesia
Date of disclosure of the study information 2016/02/12
Last modified on 2017/09/30

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Basic information
Public title Usefulness of Oxygen Reserve Index (ORi), a new parameter of oxygenation reserve potential, for rapid sequence induction of general anesthesia
Acronym Usefulness of Oxygen Reserve Index (ORi), a new parameter of oxygenation reserve potential, for rapid sequence induction of general anesthesia
Scientific Title Usefulness of Oxygen Reserve Index (ORi), a new parameter of oxygenation reserve potential, for rapid sequence induction of general anesthesia
Scientific Title:Acronym Usefulness of Oxygen Reserve Index (ORi), a new parameter of oxygenation reserve potential, for rapid sequence induction of general anesthesia
Region
Japan

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

Objectives
Narrative objectives1 To examine the usefulness of Oxygen Reserve Index (ORI), which indicates the real-time oxygenation status in hyperoxia (PaO2 of about 100-200 mmHg), during rapid sequence induction of general anesthesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Trends in ORI and SpO2 before and after rapid sequence induction of general anesthesia.
Key secondary outcomes 1. Basic patient information:
Gender, age, height, weight, date of surgery, diagnosis, operative procedure, and sensor attachment site.

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:
Blood pressure, heart rate, SpO2, SpHb of RootTM, ORI, perfusion index (PI), pleth variability index (PVI), and time from propofol administration to tracheal intubation.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult 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. No expected difficulty in tracheal intubation.

3. Submission of written informed consent for this study.
Key exclusion criteria Patients are excluded if they meet any of the following conditions:

1. Under 21 years of age.

2. Impossibility of wearing the sensor due to deformity or hypoperfusion of fingers.

3.cardiac or pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma)

4. Preoperative anemia due to hemoglobinopathies (e.g. sickle cell disease, thalassemia)

5. Ineligibility for participation in the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Murakawa
Organization Fukushima Medical University
Division name Department of Anesthesiology
Zip code
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
Middle name
Last name Tsuyoshi Isosu
Organization Fukushima Medical University
Division name Department of Anesthesiology
Zip code
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
Address
Tel
Email

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 12 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s10877-017-0068-1
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s10877-017-0068-1
Number of participants that the trial has enrolled
Results
 Data from 16 of the 20 patients were analyzed. Before oxygen administration, the median SpO2 was 98% (interquartile range[IQR] 97-98) and ORi was 0.00 in all patients. At 3 minutes after starting oxygen administration, the median SpO2 was 100% (IQR 100-100) and the median ORi was 0.50 (IQR 0.42-0.57). There was an SpO2 decline of 1% or more from the peak value after propofol administration in 13 patients, and 32.5 seconds (IQR 18.8-51.3) before the SpO2 decrease, ORi began to decline in 10 of the 13 (77%) patients.
 The ORi trends enable us to predict oxygenation reduction approximately 30 seconds before SpO2 starts to decline. By monitoring ORi, the incidence related to hypoxemia during rapid sequense induction could be reduced.
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 Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2017 Year 09 Month 27 Day
Date of closure to data entry
2017 Year 09 Month 27 Day
Date trial data considered complete
2017 Year 09 Month 27 Day
Date analysis concluded
2017 Year 09 Month 27 Day

Other
Other related information This study is an observational study.

The target population of this study is 20 consenting adult patients who are scheduled for surgical procedures under general anesthesia in our facility between January 2016 and March 2019, and meet the inclusion criteria.

To measure ORI, a sensor similar to a pulse oximeter sensor in form is applied to the third or fourth finger of each patient for a duration starting from admission to the operating room and lasting until the end of surgery. The sensor is connected to a biological function monitor Root (Masimo Corp., Irvine, CA, USA).

Anesthesia is induced by rapid sequence induction. First, oxygen 6 L/min and fentanyl 2 mcg/kg are administered. After three minutes, propofol 2 mg/kg, rocuronium 1 mg/kg and remifentanil 0.2 mcg/kg/min are simultaneously administered.
Tracheal intubation is performed either two minutes after propofol administration or when the SpO2 reaches 98%.

The main measurement items are trends in ORI and SpO2 before and after rapid sequence induction of general anesthesia.
In addition, the following items are recorded.

1. Basic information of patients:
Gender, age, height, weight, date of surgery, diagnosis, operative procedure and sensor attachment site

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:
Blood pressure, heart rate, SpO2, SpHb of RootTM, ORI, perfusion index (PI), pleth variability index (PVI), and time from propofol administration to tracheal intubation

Management information
Registered date
2016 Year 02 Month 11 Day
Last modified on
2017 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024217

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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