UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023338 |
|---|---|
| Receipt number | R000026889 |
| 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. |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2021/08/03 16:45:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
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
Condition
Patients with shock
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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.
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
| 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
Research contact person
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
jkumakumakuma@hotmail.com
Public contact
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
jkumakumakuma@hotmail.com
Sponsor or person
Institute
Sakai City Medical Center
Department of Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakai City Medical Center
Address
1-1-1, Ebaraji-cho, Nishi-ku, Sakai, Osaka, Japan
Tel
0722721199
none
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
| 2017 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
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
Progress
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
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).
Management information
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
