UMIN-CTR Clinical Trial

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
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)

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036853