UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045278 |
|---|---|
| Receipt number | R000051666 |
| Scientific Title | Effects of expiratory muscle use on lung volume and diaphragmatic contraction in patients under mechanical ventilation |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/08/26 20:22:20 |
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Basic information
Public title
Effects of expiratory effort on lung collupse and diaphragmatic contraction during mechanical ventilation
Acronym
Effect of expiratory effort on respiratory codition
Scientific Title
Effects of expiratory muscle use on lung volume and diaphragmatic contraction in patients under mechanical ventilation
Scientific Title:Acronym
Effects of expiratory muscle use on respiratory mechanics
Region
| Japan |
Condition
Condition
Acute respiratory failure
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if expiratory muscle use during mechanical ventilation effects on end-expiratory lung volume and diaphragm contraction in patients with acute respiratory failure and expiratory flow limitation
Basic objectives2
Others
Basic objectives -Others
To investigate the effect of opioid on expiratory muscle use
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thickening fraction of expiratory muscles, expiratory gastric pressure and expiratory transpulmonary pressure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute hypoxemic failure (PaO2/FIO2 ratio less than 300 mmHg) and expiratory flow limitation supposed to be on mechanical ventilator for more than 48 hours
Key exclusion criteria
Diaphragmatic dysfunction, history of neuromuscular disease, continuous infusion of neuromuscular blocker, pneumothorax/pneumomediastinum, esophageal varix, hystory of gastric or esophageal surgery, pregnancy, ready for extubation within 48 hours, disagree with th e study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Hospital
Division name
Department of emergency and disaster medicine
Zip code
7708503
Address
2-50-1 Kuramoto, Tokushima, 7708503, Japan
TEL
+81-88-633-9347
taiga@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Hospital
Division name
Department of emergency and disaster medicine
Zip code
7708503
Address
2-50-1 Kuramoto, Tokushima, 7708503, Japan
TEL
+81-88-633-9347
Homepage URL
taiga@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima, 7708503, Japan
Tel
+81-88-633-7958
brinshoshienk@tokushima-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | 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
First, we assess the presence or absence of expiratory flow limitation in patients under mechanical ventilation. Next, for patients with expiratory flow limitation, we conduct (a) simultaneous measurement of gastric, esophageal and airway pressure, and (b) ultrasonographical measurement of thickness of expiratory muscles, before and after the administration of fentanyl.
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051666
