UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039989 |
|---|---|
| Receipt number | R000045069 |
| Scientific Title | Development and Reliability/Validation of a Japanese Version of Respiratory Distress Observation scale |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2026/05/17 09:42:12 |
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Basic information
Public title
Respiratory Distress in the ICU
Acronym
ICU Respiratory Distress Observation research
Scientific Title
Development and Reliability/Validation of a Japanese Version of Respiratory Distress Observation scale
Scientific Title:Acronym
ICU RDOS
Region
| Japan |
Condition
Condition
Ventilated patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a Japanese version of RDOS
Basic objectives2
Others
Basic objectives -Others
prevalence of respiratory distress in the ICU
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reliability and validity of the Japanese version of the RDOS
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ventilator patients >= 18 years olds
Key exclusion criteria
CPAOA
Neurological diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakuramoto |
Organization
Ibaraki Christian University
Division name
College of Nursing
Zip code
319-1295
Address
6-11-1 oomika
TEL
09012642422
h.sakuramoto@icc.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakuramoto |
Organization
Ibaraki Christian University
Division name
College of Nursing
Zip code
3191295
Address
6-11-1 oomika
TEL
09012642422
Homepage URL
h.sakuramoto@icc.ac.jp
Sponsor or person
Institute
College of Nursing, Ibaraki Christian University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Address
6-11-1 oomika
Tel
09012642422
h.sakuramoto@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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255991
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255991
Number of participants that the trial has enrolled
66
Results
We conducted a prospective observational study in a 12-bed ICU to translate and validate the Japanese RDOS. The study included 42 healthcare professionals, 10 experts, and 128 ventilated patients. Scale-level content validity index was 0.95. Weighted Cohen's kappa was 0.76, and the correlation with the dyspnea visual analog scale was 0.443. The area under the ROC curve was 0.81. The optimal cutoff was 1, with sensitivity 0.89 and specificity 0.61.
Results date posted
| 2026 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 719 patients admitted to the ICU, 591 were excluded. The data of 128 patients were collected, and their characteristics are presented in Table 1. Each participant was evaluated either one or two times. In total, 213 observations were made. In 123/213 (65%) of these observations, the patient was able to communicate. Self-reported dyspnea was present in 23/213 patients (10.8%), and the mean D-VAS score was 0.61 (1.9). The mean RDOS score was 0.98 (1.2), and 22/213 patients (10.3%) had dyspnea with an RDOS score of >3.
Participant flow
Of the 719 patients admitted to the ICU, 591 were excluded. The data of 128 patients were collected, and their characteristics are presented in Table 1. Each participant was evaluated either one or two times. In total, 213 observations were made. In 123/213 (65%) of these observations, the patient was able to communicate. Self-reported dyspnea was present in 23/213 patients (10.8%), and the mean D-VAS score was 0.61 (1.9). The mean RDOS score was 0.98 (1.2), and 22/213 patients (10.3%) had dyspnea with an RDOS score of >3.
Adverse events
None
Outcome measures
The weighted Cohen's kappa coefficient and correlation coefficient between the two scales were 0.76 and 0.443, respectively (95% confidence intervals: 0.70 to 0.82 and 0.23 to 0.62, respectively). The area under the receiver operating characteristic curve for predicting self-reported dyspnea was 0.81 (95% confidence interval: 0.67 to 0.97). The optimal cutoff value was 1, with a sensitivity of 0.89 and a specificity of 0.61. Our findings indicate that the Japanese version of the RDOS demonstrated acceptable face validity, comprehensibility, criterion validity, and inter-rater reliability in mechanically ventilated patients under light sedation, suggesting its clinical usefulness.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045069
