UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055035 |
|---|---|
| Receipt number | R000049115 |
| Scientific Title | Evaluation of clinical symptom-guided partial neuromuscular blockade in COVID-19 patients |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/21 11:25:49 |
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Basic information
Public title
Evaluation of clinical symptom-guided partial neuromuscular blockade in COVID-19 patients
Acronym
E-PNMB in COVID
Scientific Title
Evaluation of clinical symptom-guided partial neuromuscular blockade in COVID-19 patients
Scientific Title:Acronym
E-PNMB in COVID
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of partial neuromuscular blockade in COVID-19 patients
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose of muscular relaxant, tidal volume, presence of reverse trigger, presence of spontaneous breathing, P0.1, TOF, PTC, Presence of backing, presence of diaphragmic costriction
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COVID-19
Key exclusion criteria
allergy against rocuronium
neuromuscular disease
no large spontaneous breathing
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | SATOKI |
| Middle name | |
| Last name | INOUE |
Organization
Nara Medical University
Division name
Anesthesiology and Intenive care
Zip code
6348521
Address
840 Shijo-cho, Kashihara, Nara, 634-8521, Japan
TEL
0744223051
seninoue@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Inoue |
Organization
Nara Medical University
Division name
Anesthesiology and Intenive care
Zip code
6348521
Address
840 Shijo-cho, Kashihara, Nara, 634-8521, Japan
TEL
0744223051
Homepage URL
https://www.naramed-u.ac.jp/~anes/index.html
seninoue@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara 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
IRB, Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara, 634-8521, Japan
Tel
744223051
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
| 2024 | Year | 07 | Month | 22 | 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
| 2021 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049115
