UMIN-CTR Clinical Trial

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
Email	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
Email	taiga@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051666