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
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
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
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
