UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056205 |
|---|---|
| Receipt number | R000064117 |
| Scientific Title | Efficacy and Safety of Early Neuromuscular Blocking Agent Therapy in Patients with Moderate to Severe ARDS: A Systematic Review |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 02:33:49 |
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Basic information
Public title
Efficacy and Safety of Early Neuromuscular Blocking Agent Therapy in Patients with Moderate to Severe ARDS: A Systematic Review
Acronym
Efficacy and Safety of Early Neuromuscular Blocking Agent Therapy in Patients with Moderate to Severe ARDS: A Systematic Review
Scientific Title
Efficacy and Safety of Early Neuromuscular Blocking Agent Therapy in Patients with Moderate to Severe ARDS: A Systematic Review
Scientific Title:Acronym
Efficacy and Safety of Early Neuromuscular Blocking Agent Therapy in Patients with Moderate to Severe ARDS: A Systematic Review
Region
| Japan |
Condition
Condition
Acute Respiratory Distress Syndrome (ARDS)
Classification by specialty
| Pneumology | Pediatrics | Emergency medicine |
| Intensive care medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of early (within 48 hours of ARDS diagnosis) neuromuscular blockade to reduce or eliminate spontaneous breathing in patients with moderate to severe ARDS, with the primary outcome being mortality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the efficacy of early neuromuscular blockade in reducing mortality among patients with moderate to severe ARDS, initiated within 48 hours of diagnosis.
Key secondary outcomes
To determine whether the use of neuromuscular blocking agents in patients with moderate or severe ARDS, initiated within 48 hours of diagnosis, improves the quality of life (QOL) as measured by EQ-5D, reduces the incidence of pressure injuries, shortens the duration of mechanical ventilation, and decreases the occurrence of ICU-acquired weakness.
A subgroup analysis will compare studies where the control group received deep sedation versus light sedation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ARDS within 48 hours
Key exclusion criteria
Patients with a history of neuromuscular blocking agent use within the past 2 weeks.
Patients with chronic respiratory failure.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Ishii |
Organization
Fukuyama City Hospital
Division name
Department of Anesthesiology, Intensive Care Unit
Zip code
721-8511
Address
5-23-1 Zao-cho, Fukuyama, Hiroshima, Japan
TEL
084-951-5151
keishii1101@gmail.com
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Ishii |
Organization
Fukuyama City Hospital
Division name
Department of Anesthesiology, Intensive Care Unit
Zip code
721-8511
Address
5-23-1 Zao-cho, Fukuyama, Hiroshima, Japan
TEL
0849415151
Homepage URL
keishii1101@gmail.com
Sponsor or person
Institute
Fukuyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuyama City 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
Fukuyama City Hospital
Address
5-23-1 Zao-cho, Fukuyama, Hiroshima, Japan
Tel
0849415151
keishii1101@gmail.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 | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The use of neuromuscular blocking agents (NMBAs) in adult patients with moderate to severe acute respiratory distress syndrome (ARDS) has been suggested to improve prognosis by reducing alveolar over-distension, pressure injury, and improving oxygenation. However, numerous complications have been reported due to the suppression or abolition of spontaneous breathing. Therefore, this systematic review aims to determine the efficacy of mechanical ventilation with NMBAs, which suppresses or abolishes spontaneous breathing.
The source of searches
PubMed
Web of Science
CENTRAL
Types of study to be included
RCT
Population
patients with moderate or severe ARDS
Intervention
neuromuscular blocking agents
Control
Placebo
Outcome
All-cause mortality
secondary outcomes
QOL as measured by EQ-5D
Incidence of pressure injuries
Duration of mechanical ventilation
Occurrence of ICU-acquired weakness
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064117
