UMIN-CTR Clinical Trial

Basic information
Public title	Effect of muscle relaxant on distribution of ventilation and aeration in patients with acute respiratory failure.
Acronym	EIT monitoring before and after administration of muscle relaxant
Scientific Title	Effect of muscle relaxant on distribution of ventilation and aeration in patients with acute respiratory failure.
Scientific Title:Acronym	EIT monitoring before and after administration of muscle relaxant
Region	Japan

Condition
Condition	respiratory failure
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of muscle relaxant on distribution of ventilation and aeration in patients with strong inspiratory effort using electrical impedance tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change in end-expiratory lung impedance before and after administration of muscle relaxant
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)mechanically ventilated patients with strong spontaneous breath 2)age 20<=, <=85 3)admission on ICU 4)written informed consent
Key exclusion criteria	1)no allergy for muscle relaxant 2)patients with accelerated respiratory drive due to central nerve impairment 3)haemodynamic instability with mean arterial pressure less than 55 mmHg 4) insuitable for EIT belt placement 5)heart beat supported by pacemaker
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Atsuko Middle name Last name Shono
Organization	Showa university
Division name	Intensive care medicine
Zip code	142-8666
Address	Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL	03-3784-8575
Email	atsukos@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Atsuko Middle name Last name Shono
Organization	Showa university
Division name	Intensive care medicine
Zip code	142-8666
Address	Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL	03-3784-8575
Homepage URL
Email	atsukos@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional review board
Address	Hantanodai1-5-9, Shinagawa, Tokyo, Japan
Tel	03-3784-8129
Email	m-rinri@ofc.showa-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	2020 Year 04 Month 21 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 06 Day
Date of IRB	2020 Year 04 Month 06 Day
Anticipated trial start date	2020 Year 04 Month 06 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	monitor the distribution of ventilation and aeration before and after administration of muscle relaxant using electrical impedance tomography in patients with strong inspiratory effort

Management information
Registered date	2020 Year 04 Month 21 Day
Last modified on	2020 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045855