UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060959 |
|---|---|
| Receipt number | R000069752 |
| Scientific Title | On the Validity of Scoring Upon Leaving the Operating Theatre |
| Date of disclosure of the study information | 2026/03/17 |
| Last modified on | 2026/03/17 11:10:56 |
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Basic information
Public title
Association Between NEWS2 Scores at PACU Discharge and Unplanned ICU Admission
Acronym
OR discharge scoring study
Scientific Title
On the Validity of Scoring Upon Leaving the Operating Theatre
Scientific Title:Acronym
PACU-NEWS2
Region
| Japan |
Condition
Condition
Postoperative patients managed in the PACU after general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated whether the use of NEWS2 for patient assessment in the recovery room enables a prompt response to changes in a patient's condition.
To this end, we investigated the association between the NEWS2 score at the time of discharge from the PACU and unplanned admission to the ICU, using patients admitted to the PACU following general anaesthesia as our study population. We also examined the usefulness of the NEWS2 score at the time of PACU discharge as a predictor of unplanned ICU admission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of unplanned ICU admission
Key secondary outcomes
Distribution of NEWS2 scores upon discharge from the PACU; association between individual NEWS2 components and unplanned ICU admission; length of stay in the PACU; requests for rapid in-hospital response (to be set as required); association with postoperative adverse events (to be set as required)
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
Patients aged 18 years or older who underwent surgery under general anesthesia at our institution and were admitted to the PACU postoperatively will be included.
Key exclusion criteria
Patients scheduled for ICU admission preoperatively or intraoperatively
Patients with missing data required for the primary outcome or main explanatory variables
Cesarean section cases
Tracheostomy cases
Other cases judged inappropriate for inclusion by the principal investigator
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kase |
Organization
The Jikei University
Division name
Department of Anesthesiology
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
crb@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Aoki |
Organization
The Jikei University
Division name
Department of Anesthesiology
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
04-7164-1111
Homepage URL
yu_ur11.5bt@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
The Jikei University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
Tel
0471641111
yu_ur11.5bt@jikei.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 | 03 | Month | 17 | 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
12000
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | 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
This study examines the distribution of NEWS2 scores at the time of discharge from the post-anaesthesia care unit (PACU) and whether patients experienced a sudden deterioration in their condition after returning to the ward, based on NEWS2 scores measured in the PACU following general anaesthesia in the operating theatres at Kashiwa Hospital between 1 July 2021 and 31 December 2025.
Management information
Registered date
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069752
