UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033022 |
|---|---|
| Receipt number | R000037645 |
| Scientific Title | Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2023/06/20 11:34:22 |
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Basic information
Public title
Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Acronym
Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Scientific Title
Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Scientific Title:Acronym
Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Region
| Japan |
Condition
Condition
Acute respiratory failure
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of neurally adjusted ventilatory assist on respiratory muscle fatigue in acute respiratoy failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diaphragm function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
neurally adjusted ventilatory assist
Interventions/Control_2
pressure support ventilation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with acute respiratory failure
Key exclusion criteria
1) Patients' refusal to participate in clinical research
2) General contraindications for gastric tube placement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | NAOYUKI |
| Middle name | |
| Last name | FUJIMURA |
Organization
St. Mary's Hospital
Division name
Department of Anesthesiology
Zip code
8308543
Address
422 Tsubukuhonmachi Kurume, Fukuoka
TEL
0942-35-3322
n-fujimura@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | NAOYUKI |
| Middle name | |
| Last name | FUJIMURA |
Organization
St. Mary's Hospital
Division name
Department of Anesthesiology
Zip code
8308543
Address
422 Tsubukuhonmachi Kurume, Fukuoka
TEL
0942-35-3322
Homepage URL
n-fujimura@st-mary-med.or.jp
Sponsor or person
Institute
St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Mary's Hospital
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
St. Mary's Hospital Our Lady of the Snow Social Medical Corporation
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
Tel
0942-35-332
n-fujimura@st-mary-med.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
13-1003
Org. issuing International ID_1
St. Mary's Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037645
