UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Anesthesiology, Fukushima Medical University

Institute

Department

Personal name

Organization

Department of Anesthesiology, Fukushima Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

02

Month

12

Day

URL releasing protocol

https://link.springer.com/article/10.1007/s10877-017-0068-1

Publication of results

Published

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

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 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

Registered date

2016

Year

02

Month

11

Day

Last modified on

2017

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024217