UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032920
Receipt number R000036853
Scientific Title Correlation and agreement between esophageal pressure changes and central venous pressure changes during mechanical ventilation in patients with acute respiratory failure
Date of disclosure of the study information 2018/06/11
Last modified on 2021/12/13 11:35:52

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Basic information

Public title

Correlation and agreement between esophageal pressure changes and central venous pressure changes during mechanical ventilation in patients with acute respiratory failure

Acronym

Correlation and agreement between esophageal pressure changes and central venous pressure changes

Scientific Title

Correlation and agreement between esophageal pressure changes and central venous pressure changes during mechanical ventilation in patients with acute respiratory failure

Scientific Title:Acronym

Correlation and agreement between esophageal pressure changes and central venous pressure changes

Region

Japan


Condition

Condition

acute respiratory failure

Classification by specialty

Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

we compare central venous pressure changes to esophageal pressure changes to study whether central venous pressure changes can be a surrogate of intrapleural pressure changes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

correlation and agreement between central venous pressure changes and esophageal pressure changes

Key secondary outcomes

correlation and agreement between central venous pressure changes which are calibrated based on those changes during occlusion test, and esophageal pressure changes


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Esophageal pressure measurements and central venous pressuremesurements will be performed when mechanical ventilation is initiated, and whenever settings of mechanical ventilation are changed or a patient's reapiratory condition changes significantly during mechanical ventilation or for five days, whichever is shorter.

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

patients who are mechanically ventilated under intubation for acute respiratory failure and who are inserted a central venous catheter

Key exclusion criteria

patients who need rapid infusion for hemodynamically instability, who have pneumothorax or undergo thoracotomy, who have esophageal anatomical abnormalities (ex.tumors,stenosis, or esophageal varices), or who suffer esophageal or gastric hemorrhage

Target sample size

75


Research contact person

Name of lead principal investigator

1st name Tomoyo
Middle name
Last name Nishida

Organization

Osaka city general hospital

Division name

Anesthesia department

Zip code

534-0021

Address

2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka city,Japan

TEL

0669291221

Email

t-nishida@med.osakacity-hp.or.jp


Public contact

Name of contact person

1st name Tomoyo
Middle name
Last name Nishida

Organization

Osaka city general hospital

Division name

Anesthesia department

Zip code

534-0021

Address

2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka city,Japan

TEL

0669291221

Homepage URL


Email

t-nishida@med.osakacity-hp.or.jp


Sponsor or person

Institute

Osaka city general hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka city general hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka city general hospital

Address

2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka city,Japan

Tel

0669291221

Email

xc0017@osakacity-hp.or.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

地方独立行政法人大阪市民病院機構大阪市立総合医療センター


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 11 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

12

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

Terminated

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 07 Month 10 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 08 Day

Last modified on

2021 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036853


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name