UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of spontaneous inspiratory effort using inspiratory muscle echocardiography in patients with ARDS
Acronym	MUSCLE echo-ARDS study
Scientific Title	Assessment of spontaneous inspiratory effort using inspiratory muscle echocardiography in patients with ARDS
Scientific Title:Acronym	MUSCLE echo-ARDS study
Region	Japan

Condition
Condition	Acute respiratory distress syndrome (ARDS)
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigate whether spontaneous inspiratory effort can be accurately assessed by diaphragmatic and intercostal muscle echocardiography in patients with ARDS
Basic objectives2	Others
Basic objectives -Others	If we can confirm that noninvasive echocardiography can be used to evaluate spontaneous inspiratory effort without an intraesophageal pressure balloon
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To determine whether the thickening fraction of diaphragmatic and intercostal muscle echoes can predict strong spontaneous breathing (delta Pes>10 cmH2O)
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 diagnosed with ARDS and undergoing invasive ventilatory management with PaO2/FiO2 < 150 mmHg - Patients who require an esophageal pressure catheter for monitoring
Key exclusion criteria	- There is a contraindication to esophageal pressure catheter insertion (varices, postoperative upper gastrointestinal tract, or other physician's judgment) - History of neuromuscular disease (history of stroke not affecting respiratory muscles is not an exclusion) - Intercostal muscle echocardiography is affected after an invasive intervention on the thorax, such as after cardiovascular surgery or thoracic surgery - If thoracic deformity is present - If the patient has chronic respiratory failure using home oxygen therapy or non-invasive ventilation
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Kataoka
Organization	Nerima Hikarigaoka Hospital
Division name	Department of Critical Care Medicine
Zip code	179-0072
Address	2-11-1, Hikarigaoka, Nerima-ku, Tokyo, Japan
TEL	0339793611
Email	rdcyc910@yahoo.co.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Kataoka
Organization	Nerima Hikarigaoka Hospital
Division name	Department of Critical Care Medicine
Zip code	179-0072
Address	2-11-1, Hikarigaoka, Nerima-ku, Tokyo, Japan
TEL	0339793611
Homepage URL
Email	rdcyc910@yahoo.co.jp

Sponsor
Institute	Nerima Hikarigaoka Hospital
Institute
Department

Funding Source
Organization	Not applicable
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Emergency and Critical Care Medicine, St. Marianna University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee, Nerima Hikarigaoka Hospital
Address	2-11-1, Hikarigaoka, Nerima-ku, Tokyo, Japan
Tel	0339793611
Email	hidetoshiy@jadecom.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 09 Month 20 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	2021 Year 02 Month 05 Day
Date of IRB	2021 Year 02 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 18 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

- If the patient is on assisted ventilation (AC-PC or PSV) with spontaneous breathing, measure daily (up to day 7). - Confirm that the patient is breathing steadily and record ventilator settings and arterial blood gas findings at that time. - Diaphragmatic echo is measured in the ninth or tenth intercostal space between the mid-axilla or anterior axis - Intercostal muscle echo is measured at the right margin of the sternum in the second intercostal space. - A high-frequency linear probe is used and the probing site is marked for consistency of daily measurements. - End-expiratory and end-inspiratory diameters are measured and recorded for three stable breaths. - TFic and TFdi are calculated from end expiratory and end inspiratory diameters and averaged over 3 stable breaths - Delta Pes and delta PL-dyn are measured as monitoring by esophageal pressure balloon. (When Hamilton G5/C6 is used, PTPes is also recorded in the same way.) - If the ventilator is capable of measurement, P0.1 and delta Pocc are measured and the average of 3 stable breaths is calculated. - Determine the need for continuous daily use of muscle relaxation; if there are strong spontaneous breaths and the clinician determines that muscle relaxation is needed, this should be clearly indicated. - Measure Crs and Rrs after subsequent use of muscle relaxation

Management information
Registered date	2022 Year 09 Month 20 Day
Last modified on	2022 Year 09 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055789