UMIN-CTR Clinical Trial

Basic information
Public title	evaluation of ventilation distribution during stepwise recruitment maneuver and decremental PEEP trial using electrical impedance tomography
Acronym	Optimal PEEP selected by SRM and EIT
Scientific Title	evaluation of ventilation distribution during stepwise recruitment maneuver and decremental PEEP trial using electrical impedance tomography
Scientific Title:Acronym	Optimal PEEP selected by SRM and EIT
Region	Japan

Condition
Condition	mechanically ventilated patients with respiratory failure
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare optimal PEEP levels selected by different methods using best compliance detected by SRM (automatically performed function of recruitment maneuver installed in Servo-U ventilator)and EIT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Optimal PEEP level selected by SRM (automatically performed function of recruitment maneuver installed in Servo-U ventilator)
Key secondary outcomes	Optimal PEEP level selected by EIT Ventilation distribution Respiratory parameters Blood gas analysis

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)patients with respiratory failure 2)Age>=20, <=85 3)admitted in ICU 4)written informed consent
Key exclusion criteria	1)no indication of mechanical ventilation 2)hemodynamically unstable with mean blood pressure less than 55 mmHg 3)Not suitable for EIT attachment 4)patients with medical history of pneumothorax
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Somei
Organization	Showa University
Division name	Intensive care medicine
Zip code	142-8666
Address	Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL	03-3784-8575
Email	some_papaiya@yahoo.co.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Somei
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	some_papaiya@yahoo.co.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	Showa University Research Ethics Review Board
Address	Hatanodai1-5-8, 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	2022 Year 04 Month 09 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 08 Month 11 Day
Date of IRB	2020 Year 08 Month 11 Day
Anticipated trial start date	2020 Year 08 Month 11 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	Stepwise recruitment maneuver followed by PEEP titration is performed using Servo-U ventilator automatically. Evaluate ventilation distribution and select optimal PEEP level with best compliance, which is compared to the optimal PEEP level detected by EIT

Management information
Registered date	2022 Year 04 Month 09 Day
Last modified on	2022 Year 04 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054108