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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032920
Receipt No. R000036853
Official scientific title of the study 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 2018/07/18

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Basic information
Official scientific title of the study Correlation and agreement between esophageal pressure changes and central venous pressure changes during mechanical ventilation in patients with acute respiratory failure
Title of the study (Brief title) 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 transpulmonary pressures calculated using central venous pressure changes and transpulmonary pressures calculated using 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 Tomoyo Nishida
Organization Osaka city general hospital
Division name Anesthesia department
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 Tomoyo Nishida
Organization Osaka city general hospital
Division name Anesthesia department
Address 2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka city,Japan
TEL 0669291221
Homepage URL
Email t-nishida@med.osakacity-hp.or.jp

Sponsor
Institute Osaka city general hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 08 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.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
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