UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062858 |
|---|---|
| Receipt number | R000071310 |
| Scientific Title | Impact of the Fentanyl Supply Shortage on 28-Day Ventilator-Free Days -Changes in Analgesia and Sedation Strategies Following the Fentanyl Supply Shortage- |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 14:36:33 |
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Basic information
Public title
Impact of the Fentanyl Supply Shortage on 28-Day Ventilator-Free Days
-Changes in Analgesia and Sedation Strategies Following the Fentanyl Supply Shortage-
Acronym
Impact of the Fentanyl Supply Shortage on 28-Day Ventilator-Free Days
-Changes in Analgesia and Sedation Strategies Following the Fentanyl Supply Shortage-
Scientific Title
Impact of the Fentanyl Supply Shortage on 28-Day Ventilator-Free Days
-Changes in Analgesia and Sedation Strategies Following the Fentanyl Supply Shortage-
Scientific Title:Acronym
Impact of the Fentanyl Supply Shortage on 28-Day Ventilator-Free Days
-Changes in Analgesia and Sedation Strategies Following the Fentanyl Supply Shortage-
Region
| Japan |
Condition
Condition
Critically ill patients requiring mechanical ventilation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this retrospective multicenter study is to evaluate the impact of changes in analgesia and sedation strategies associated with the fentanyl supply shortage on 28-day ventilator-free days among critically ill adult patients receiving invasive mechanical ventilation in the intensive care unit. Using the One ICU database, changes before and after the supply shortage will be compared across institutions and assessed using a difference-in-differences approach.
Basic objectives2
Others
Basic objectives -Others
To characterize changes in analgesia and sedation strategies before and after the fentanyl supply shortage, including the selection, dosage, and combination of analgesic and sedative agents in mechanically ventilated adult ICU patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day ventilator-free days (VFDs)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years or older who were admitted to the ICU at participating institutions between January 1, 2022, and December 31, 2025, received invasive mechanical ventilation, and had the required data available in the One ICU database.
Key exclusion criteria
Patients younger than 18 years
Patients who did not receive invasive mechanical ventilation during their ICU stay
Patients with missing data for the primary outcome or key covariates required for the analysis
Duplicate records from the same hospitalization (only the first ICU admission will be included)
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Oto |
| Middle name | |
| Last name | Jun |
Organization
Tokushima university Graduate School of Biomedical Sciences
Division name
Department of Emergency and Critical Care Medicine
Zip code
7708503
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima 770-8503, Japan
TEL
0886339347
joto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Nunomura |
| Middle name | |
| Last name | Toshiyuki |
Organization
Tokushima university hospital
Division name
Department of Emergency and Disaster Medicine
Zip code
7708503
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima 770-8503, Japan
TEL
09032203320
Homepage URL
nunotsyk2009@gmail.com
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima university 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
Department of Clinical and Translational Science, Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima 770-8503, Japan
Tel
0886339294
awachiken@tokushima-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
| 2026 | Year | 09 | Month | 09 | 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
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study using the OneICU database. Adult patients admitted to participating ICUs between January 1, 2022 and December 31, 2025 who received invasive mechanical ventilation will be included. We will evaluate changes in analgesic and sedative use before and after the fentanyl supply restriction and investigate the association between the fentanyl supply restriction and clinical outcomes, including 28-day ventilator-free days. Changes in the use of alternative analgesic agents and analgosedation strategies will also be evaluated. No additional intervention, examination, or specimen collection will be performed, and only routinely collected clinical data will be analyzed.
Management information
Registered date
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071310
