UMIN-CTR Clinical Trial

Basic information
Public title	The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Acronym	The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Scientific Title	The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Scientific Title:Acronym	The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Region	Japan

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

Objectives
Narrative objectives1	Lung-protective mechanical ventilation with the use of lower tidal volumes is beneficial for patients with ARDS and without ARDS. However, there is little evidence about a specific amount of tidal volume less than 10ml/kg/PBW. Achieving 6ml/kg/PBW of tidal volume without neuromuscular blockade is sometimes interrupted by the patients-ventilator asynchrony (PVA). PVA is defined as a mismatch between the patient breathing efforts with a ventilator's breath delivery. A higher incidence of PVA is significantly related to ICU mortality. Reverse triggering (RT) is one of the types of PVA, which is defined as the inspiratory effort due to the mandatory breathe by a mechanical ventilator. RT is a notable phenomenon because the incidence of RT is almost fifty percent of mechanically ventilated ARDS patients and RT may exacerbate the lung injury. Lower tidal volume may also relate to the incidence of RT according to a prospective multicenter observational study. Therefore, this study aims to investigate the incidence of RT in mechanically ventilated patients receiving 6ml/kg/PBW compared to 7.5 ml/kg/PBW.
Basic objectives2	Others
Basic objectives -Others	This study aims to clarify the incidence of RT in mechanically ventilated patients with acute respiratory failure (PaO2/FIO2 < 300mmHg) including ARDS, comparing 6 ml/kg PBW of tidal volume with 7.5 ml/kg PBW.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of reverse triggering [Time frame: during 45 minutes]
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Tidal volume 6 ml/kg (Predicted Body Weight) [Time frame: during 15 minutes]
Interventions/Control_2	Tidal volume 7.5 ml/kg (Predicted Body Weight) [Time frame: during 15 minutes]
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	Age > 20 years old, <85 years old Acute respiratory failure and ARDS (PaO2/FIO2 < 300mmHg) Those who can obtain written consent from the substitute for participation in this study Receiving intubation within 72 hours Being expected to receive mechanical ventilation at least 72 hours.
Key exclusion criteria	Receiving neuromuscular blockage brain death bronchoalveolar fistula post esophageal cancer surgery contraindication to Edi catheter insertion (Esophageal varices and perforation) using ECMO (extracorporeal membrane oxygenation) mechanical ventilation due to asthma and COPD hemodynamic instability pregnant patient Those who are deemed inappropriate by the principal investigator or research co-investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Nobuaki Middle name Last name Shime
Organization	Hiroshima University
Division name	Department of Emergency and Critical Care Medicine
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5456
Email	nshime@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Michihito Middle name Last name Kyo
Organization	Hiroshima University
Division name	Department of Emergency and Critical Care Medicine
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5456
Homepage URL
Email	mkyo@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Committee for Clinical Research of Hiroshima University
Address	Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel	0822571551
Email	iryo-seisaku@office.hiroshima-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 01 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
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 09 Month 29 Day
Date of IRB	2020 Year 12 Month 23 Day
Anticipated trial start date	2021 Year 01 Month 11 Day
Last follow-up date	2023 Year 03 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	2021 Year 01 Month 11 Day
Last modified on	2021 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047823

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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