UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011766
Receipt number R000013749
Scientific Title Accuracy of the End-Tidal synchronized Central Venous Pressure (CVP-ET) under mechanical ventilation
Date of disclosure of the study information 2013/09/14
Last modified on 2013/09/14 15:15:37

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Basic information

Public title

Accuracy of the End-Tidal synchronized Central Venous Pressure (CVP-ET) under mechanical ventilation

Acronym

Accuracy of the End-Tidal synchronized Central Venous Pressure (CVP-ET) under mechanical ventilation

Scientific Title

Accuracy of the End-Tidal synchronized Central Venous Pressure (CVP-ET) under mechanical ventilation

Scientific Title:Acronym

Accuracy of the End-Tidal synchronized Central Venous Pressure (CVP-ET) under mechanical ventilation

Region

Japan


Condition

Condition

patients undergoing surgery with general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the efficacy of End-Tidal synchronized Central Venous Pressure (CVP-ET) under mechanical ventilation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison between Central Venous Pressure (CVP) and End-Tidal synchronized Central Venous Pressure (CVP-ET).

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

central venous pressure

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing general anesthesia with monitoring of central venous pressure.

Key exclusion criteria

respiratory disease

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiyuki Araki

Organization

National Defense Medical College

Division name

Department of Anesthesiology

Zip code


Address

Namiki 3-2, Tokorozawa-city, Saitama

TEL

04-2995-1211

Email

dr23043@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiyuki Araki

Organization

National Defense Medical College

Division name

Department of Anesthesiology

Zip code


Address

Namiki 3-2, Tokorozawa-city, Saitama

TEL

04-2995-1211

Homepage URL


Email

dr23043@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

National Defense Medical College and Department Funding

Organization

Division

Category of Funding Organization

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

2013 Year 09 Month 14 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

Completed

Date of protocol fixation

2010 Year 10 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 14 Day

Last modified on

2013 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name