UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058470 |
|---|---|
| Receipt number | R000066807 |
| Scientific Title | Usefulness of Monitoring for Acute Respiratory Failure and Autonomic Symptoms in Adults With Neuromuscular Diseases: A Scoping Review |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/15 07:48:33 |
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Basic information
Public title
Usefulness of Monitoring for Acute Respiratory Failure and Autonomic Symptoms in Adults With Neuromuscular Diseases: A Scoping Review
Acronym
Usefulness of Monitoring for Acute Respiratory Failure and Autonomic Symptoms in Adults With Neuromuscular Diseases: A Scoping Review
Scientific Title
Usefulness of Monitoring for Acute Respiratory Failure and Autonomic Symptoms in Adults With Neuromuscular Diseases: A Scoping Review
Scientific Title:Acronym
Usefulness of Monitoring for Acute Respiratory Failure and Autonomic Symptoms in Adults With Neuromuscular Diseases: A Scoping Review
Region
| Japan |
Condition
Condition
neuromuscular disease
Classification by specialty
| Neurology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify and describe current monitoring practices for acute respiratory and autonomic complications in neuromuscular disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes include mortality, length of ICU stay, neurological outcome, need for mechanical ventilation, and stabilization of autonomic dysfunction.
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
P (Population)
Patients with neuromuscular diseases requiring respiratory and/or circulatory monitoring
I (Intervention)
Patients who underwent physiological monitoring
C (Comparison)
Patients who did not undergo physiological monitoring
O (Outcome)
Mortality, length of ICU stay, neurological outcomes, use of mechanical ventilation, and stabilization of autonomic dysfunction
Key exclusion criteria
Adolescents (under 15 years of age)
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology, Emergency and Critical Care Center
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
TEL
0282-86-1111
eisei@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology, Emergency and Critical Care Center
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
TEL
0282-86-1111
Homepage URL
eisei@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
Tel
0282-86-1111
eisei@dokkyomed.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 | 15 | 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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 23 | 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
In patients with neuromuscular diseases, respiratory failure and autonomic symptoms are known to be associated with poor outcomes. Early identification of individuals at high risk for these complications and appropriate monitoring are critically important for improving patient prognosis.
However, existing clinical guidelines have not provided specific recommendations for respiratory or autonomic monitoring in neuromuscular disorders.
Therefore, we conducted a systematic review of monitoring focused on respiratory failure in neuromuscular disorders, targeting patients from the emergency room (ER) to intensive care units (ICUs).
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066807
