UMIN-CTR Clinical Trial

Public title

Detecting central-venous oxygen saturation without a central-venous catheter: Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial - multi-center prospective observational study.

Acronym

Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial for detecting ScvO2

Scientific Title

Detecting central-venous oxygen saturation without a central-venous catheter: Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial - multi-center prospective observational study.

Scientific Title:Acronym

Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial for detecting ScvO2

Region

Japan

Condition

Patients with shock

Classification by specialty

Emergency medicine	Intensive care medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial for detecting whether central venous saturation is lower than 70% among patients with shock.

Basic objectives2

Others

Basic objectives -Others

Observational study to evaluate diagnostic accuracy

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Whether central venous saturation is lower than 70% at the first measurement.

Key secondary outcomes

Whether central venous saturation is lower than 70% at the 6 hour later from first measurement.

Whether central venous saturation is lower than 65% at the first measurement.
Whether central venous saturation is lower than 65% at the 6 hour later from first measurement.

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

all patients who meet following criteria
1) patients who are admitted to Intensive Care Units
2) patients whose systolic blood pressure measured by invasively at radial(ABPs) gets down under 90 mm Hg
3) patients who meet the following shock criteria

definition of shock: need vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg and or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia.

Key exclusion criteria

1) patients who are younger than 16 years old
2) patients who have shunt
3) patients who have arteriovenous shunt
4) patients who withdrew from resuscitation
5) patients who are expected to die within 6 hours

Target sample size

178

Name of lead principal investigator

1st name	Junji
Middle name
Last name	Kumasawa

Organization

Sakai City Medical Center

Division name

Department of Critical Care Medicine

Zip code

593-8304

Address

1-1-1, Ebaraji-cho, Nishi-ku, Sakai City, Osaka, Japan

TEL

072-272-1199

Email

jkumakumakuma@hotmail.com

Name of contact person

1st name	Junji
Middle name
Last name	Kumasawa

Organization

Sakai City Medical Center

Division name

Department of Critical Care Medicine

Zip code

593-8304

Address

1-1-1, Ebaraji-cho, Nishi-ku, Sakai City, Osaka, Japan

TEL

072-272-1199

Homepage URL

Email

jkumakumakuma@hotmail.com

Institute

Sakai City Medical Center
Department of Critical Care Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Sakai City Medical Center

Address

1-1-1, Ebaraji-cho, Nishi-ku, Sakai, Osaka, Japan

Tel

0722721199

Email

none

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

2017

Year

01

Month

20

Day

URL releasing protocol

none

Publication of results

Unpublished

URL related to results and publications

none

Number of participants that the trial has enrolled

120

Results

On going

Results date posted

2021

Year

08

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

On going

Participant flow

On going

Adverse events

None

Outcome measures

On going

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

28

Day

Date of IRB

2016

Year

12

Month

28

Day

Anticipated trial start date

2017

Year

09

Month

28

Day

Last follow-up date

2020

Year

04

Month

01

Day

Date of closure to data entry

2020

Year

04

Month

01

Day

Date trial data considered complete

2020

Year

04

Month

01

Day

Date analysis concluded

2021

Year

04

Month

01

Day

Other related information

Arterial blood pressure is measured using an arterial catheter in a radial artery. The catheter is connected to a pressure transducer or flotrac. The transducer is zeroed to atmospheric pressure and referenced to the midaxillary line with the patient in the supine position. On the same side as the radial-artery catheter, noninvasively measured brachial blood pressure (NIBP) is measured by oscillometry wit a brachial cuff. The size of the cuff is chosen according to recent guidelines. NIBP is measured consecutively three times, and the mean is recorded. These measurements are recorded at two point, after the admission to ICU and the 6 hours later. We use "delta-BP" to refer to the difference between ABPs and NIBPs (ie, ABPs minus NIBPs). We also record each patient's age, sex, cause of admission, heart rate, blood pressure (systolic, diastolic, and mean, from both invasive and noninvasive measurements), use of mechanical ventilation, Acute Physiology and Chronic Health Evaluation II score, Sequential Organ Failure Assessment score, cardiac output/cardiac index, systemic vascular resistance, hemoglobin level, arterial blood oxygen saturation, partial pressure of arterial and central venous carbon dioxide, lactate level and measurements of echocardiography (ejection fraction, diastolic left ventricular diameter and systolic left ventricular diameter). Statistical analysis. We perform logistic regression analysis as delta-BP is independent variable and ScvO2 < 70%, which is measured at first measurement, is dependent variable. We calculate the area under the ROC curve for delta-BP as an indicator of ScvO2 < 70%. As pre-defined sub analysis, we performed logistic analysis with using the sub set which exclude patients who are underwent cardiac surgery and are arrested.
We calculate Spearmen's rank correlation between delta-BP and SVR, CO or CI. We use STATA version 13 (STATA, College Station, TX).

Registered date

2016

Year

07

Month

26

Day

Last modified on

2021

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026889