UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037468
Receipt number R000042711
Scientific Title Accuracy of continuous non-invasive arterial pressure in infants and toddlers
Date of disclosure of the study information 2020/01/01
Last modified on 2022/07/29 08:33:56

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Basic information

Public title

Accuracy of continuous non-invasive arterial pressure in infants and toddlers

Acronym

Accuracy of continuous non-invasive arterial pressure in infants and toddlers

Scientific Title

Accuracy of continuous non-invasive arterial pressure in infants and toddlers

Scientific Title:Acronym

Accuracy of continuous non-invasive arterial pressure in infants and toddlers

Region

Japan


Condition

Condition

Patients < 36 months

Classification by specialty

Surgery in general Pediatrics Anesthesiology
Laboratory medicine Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the accuracy of measurements with Clearsight in infants and toddlers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare continuous non-invasive arterial pressure measurement with Clearsight to invasive or non-invasive arterial pressure measurement.

Key secondary outcomes

Compare cardiac output and stroke volume with Clearsight to echocardiographic measurements.


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


Not applicable

Age-upper limit

3 years-old >

Gender

Male and Female

Key inclusion criteria

- A patient < 36 months
- Surgery requiring invasive arterial pressure measurement(catheter insertion to artery)
- A patient who has obtained informed consent from a parent

Key exclusion criteria

- Patient > 36 months
- Surgery with only by non-invasive arterial pressure measurement
- A patient who has not obtained explanatory consent
- Patients with extreme contraction in arteries (such as Raynaud's disease)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kimitoshi
Middle name
Last name Nishiwaki

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku

TEL

052-744-2340

Email

nishi@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Tasuku
Middle name
Last name Fujii

Organization

Nagoya University Hospital

Division name

Department of Anesthesiology

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku

TEL

052-744-2340

Homepage URL


Email

plus9@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

40


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Nagoya University Graduate School of Medicine

Address

65 Tsurumai-cho, Showa-ku

Tel

052-744-2973

Email

ethics@med.nagoya-u.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

2020 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Enrolling by invitation

Date of protocol fixation

2019 Year 08 Month 01 Day

Date of IRB

2020 Year 01 Month 28 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study
- intragroup comparison


Management information

Registered date

2019 Year 07 Month 24 Day

Last modified on

2022 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042711


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name