UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058595 |
|---|---|
| Receipt number | R000066020 |
| Scientific Title | Prospective observational study on the relationship between diaphragmatic action potentials and extubation outcomes during ventilatory management |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/25 14:01:29 |
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Basic information
Public title
Prospective observational study on the relationship between action potentials emitted by the diaphragm during ventilatory management and the possibility of extubation
Acronym
diaphragmatic action potential test
Scientific Title
Prospective observational study on the relationship between diaphragmatic action potentials and extubation outcomes during ventilatory management
Scientific Title:Acronym
diaphragmatic action potential test
Region
| Japan |
Condition
Condition
Respiratory failure requiring ventilator management in the intensive care unit
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Continuous evaluation of Edi (Electrical activity of the diaphragm) and its relationship to VFD28 (ventilator free days at 28days)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the relationship between the Edi from intubation to extubation and the VFD28.
Key secondary outcomes
Relationship between UAB (unassisted breathing) and Edi at 30 days, and mortality and Edi at 30 days
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 18 years of age or older
2. Patients who started ventilator management by oral intubation
3. Cases in which muscle relaxants are administered at the start of ventilation
4.Can be managed in Assist/Control Mode
5. Ventilated with Puritan Bennett980/840, SERVO-U Ventilator, Hamilton C6
6.Patients expected to survive more than 24 hours
Key exclusion criteria
1. patients who were intubated upon ICU admission
2. pregnant women
3. patients whose diaphragmatic function is not expected to recover (e.g., end-stage neuromuscular disease)
4. Artificial respiration for more than 8 hours prior to admission to the ICU
5. patients who have been in the ICU within the past month
6. patients who have undergone invasive positive pressure ventilation for non-surgical reasons within the past month
7. whose Code is DNAR
8. lack of equipment such as Servo series, NAVA Catheter, etc. 8.
9. absence of investigator
10. failure to obtain research consent
11. drug intoxication
12. brain death
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | YUSUKE |
| Middle name | |
| Last name | NAITO |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
schneider.yusuke@gmail.com
Public contact
Name of contact person
| 1st name | YUSUKE |
| Middle name | |
| Last name | NAITO |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
schneider.yusuke@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Medical Ethics Review Committee Secretariat
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-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
| 2025 | Year | 07 | Month | 25 | 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
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066020
