UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048967 |
|---|---|
| Receipt number | R000055789 |
| Scientific Title | Assessment of spontaneous inspiratory effort using inspiratory muscle echocardiography in patients with ARDS |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2022/09/20 06:18:24 |
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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
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
rdcyc910@yahoo.co.jp
Sponsor or person
Institute
Nerima Hikarigaoka Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055789
