UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057447 |
|---|---|
| Receipt number | R000065639 |
| Scientific Title | Prevalence and risk factors for dyspnoea in critically ill patients: A multicenter observational study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/29 16:56:54 |
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Basic information
Public title
Prevalence and risk factors for dyspnoea in critically ill patients: A multicenter observational study
Acronym
Prevalence and risk factors for dyspnoea in critically ill patients: A multicenter observational study
Scientific Title
Prevalence and risk factors for dyspnoea in critically ill patients: A multicenter observational study
Scientific Title:Acronym
Prevalence and risk factors for dyspnoea in critically ill patients: A multicenter observational study
Region
| Japan |
Condition
Condition
Critically ill mechanial ventilated patients in intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate dyspnoea in ventilated patients in ICUs in Japan and to determine the prevalence for dyspnoea during ventilatory therapy.
Basic objectives2
Others
Basic objectives -Others
Exploring risk factors for dyspnoea symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence for dyspnea
Key secondary outcomes
Risk factors for dyspnea
Association with patient 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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged between 18 and 100 years who are expected to receive ventilatory management in intensive care units for more than 48 hours.
Key exclusion criteria
(i) Patients with COVID-19 as the cause of admission (COVID-19 is diagnosed in patients with a positive PCR test and a confirmed diagnosis)
(ii) Patients expected to be discharged from the ICU within 48 hours
(iii) Severe cognitive impairment
(iv) Severe psychiatric disorders
(v) Patients admitted to the intensive care unit more than once during the same admission (patients admitted for the second and subsequent admissions are excluded)
(vi) Patients who cannot understand Japanese
(vii) End of life/terminal care patients whose purpose of admission was not treatment (Inclusion if the patient was shifted to terminal care during admission)
(viii) Patients whose consent could not be obtained.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ouchi |
Organization
Ibaraki Christian University
Division name
College of nursing
Zip code
319-1295
Address
6-11-1 Omika, Hitachi, Ibaraki, Japan
TEL
029-452-3215
akira.ouchi@icc.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ouchi |
Organization
Ibaraki Christian University
Division name
College of nursing
Zip code
319-1295
Address
6-11-1 Omika, Hitachi, Ibaraki, Japan
TEL
029-452-3215
Homepage URL
akira.ouchi@icc.ac.jp
Sponsor or person
Institute
Ibaraki Christian University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Christian University Ethics Review Committee
Address
6-11-1 Omika, Hitachi, Ibaraki, Japan
Tel
029-452-3215
rinri2@icc.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 | 04 | Month | 01 | 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 | 12 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The presence and degree of dyspnoea will be assessed from the date of enrolment until the patient is extubated. The specific method of assessment is that researchers from the collaborating institutions assess dyspnoea at the bedside of eligible patients using the objective dyspnoea scale (RDOS); the presence or absence of dyspnoea is assessed from the RDOS score. In patients with a RASS of -2 or higher and who are able to self-report, dyspnoea is also assessed by interviewing the individual using the NRS (or VAS) to assess the presence and degree of dyspnoea.
Management information
Registered date
| 2025 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065639
