UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055111 |
|---|---|
| Receipt number | R000062958 |
| Scientific Title | Respiratory management for acute respiratory failure in neuromuscular diseases: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2024/07/30 |
| Last modified on | 2024/07/30 11:32:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Respiratory management for acute respiratory failure in neuromuscular diseases: A systematic review and meta-analysis
Acronym
Respiratory management for acute respiratory failure in neuromuscular diseases: A systematic review and meta-analysis
Scientific Title
Respiratory management for acute respiratory failure in neuromuscular diseases: A systematic review and meta-analysis
Scientific Title:Acronym
Respiratory management for acute respiratory failure in neuromuscular diseases: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
neuromuscular diseases
Classification by specialty
| Neurology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acute respiratory failure (ARF) is the most common life-threatening complication in patients with neuromuscular diseases (NMD). Respiratory support including oxygen therapy, invasive ventilation (IV) or noninvasive ventilation (NIV) can be offered. However, the most effective respiratory management for ARF in NMD remains unclear. this study aim to assess the most effective respiratory management for ARF in NMD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality
Key secondary outcomes
Length of stay in the ICU, good neurological outcome rates, duration of ventilation, avoiding tracheotomy, pneumonia.
Base
Study type
Others,meta-analysis etc
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
We searched PubMed, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi until published up to July 2024. We included randomized controlled trials (RCTs) and non-randomized studies comparing IV to NIV, or NIV to any forms of oxygen therapies, or NIV to any forms of oxygen therapies for acute respiratory failure in neuromuscular diseases.
Key exclusion criteria
We searched PubMed, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi until published up to July 2024. We included randomized controlled trials (RCTs) and non-randomized studies comparing IV to NIV, or NIV to any forms of oxygen therapies, or NIV to any forms of oxygen therapies for acute respiratory failure in neuromuscular diseases.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Sunghoon |
| Middle name | |
| Last name | Yang |
Organization
Touto Sangenjyaya Rehabilitation Hospital
Division name
Department of Neurology
Zip code
1540024
Address
1-24-3 Sangenjaya, Setagaya, Tokyo
TEL
81354331211
yang_sung_hoon@hotmail.com
Public contact
Name of contact person
| 1st name | Sunghoon |
| Middle name | |
| Last name | Yang |
Organization
Touto Sangenjyaya Rehabilitation Hospital
Division name
Department of Neurology
Zip code
1540024
Address
1-24-3 Sangenjaya, Setagaya, Tokyo
TEL
81354331211
Homepage URL
yang_sung_hoon@hotmail.com
Sponsor or person
Institute
Touto Sangenjyaya Rehabilitation Hospital
Institute
Department
Personal name
Yang Sunghoon
Funding Source
Organization
Touto Sangenjyaya Rehabilitation 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
Touto Sangenjyaya Rehabilitation Hospital
Address
1-24-3 Sangenjaya, Setagaya, Tokyo
Tel
81354331211
yang_sung_hoon@hotmail.com
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
| 2024 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods: We searched PubMed, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi until published up to July 2024. We included randomized controlled trials (RCTs) and non-randomized studies comparing IV to NIV, or NIV to any forms of oxygen therapies, or NIV to any forms of oxygen therapies for ARF in NMD. We set the critical outcome as hospital mortality, important outcome as length of stay in the intensive care unit (ICU). Two review authors independently assessed trials for inclusion criteria and methodological quality, extracted data, and risk of bias. Authors used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence.
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062958
