UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061173 |
|---|---|
| Receipt number | R000070003 |
| Scientific Title | Safety and Efficacy of Real-time Ultrasound-Guided Seldinger Technique versus Pre-scan Marking for Small-Bore Chest Tube Insertion in the Intensive Care Unit: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/07 12:32:01 |
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Basic information
Public title
Comparative study of real-time ultrasound-guided versus conventional methods for pleural effusion treatment in the ICU
Acronym
Safety of real-time ultrasound-guided pleural effusion treatment in the ICU
Scientific Title
Safety and Efficacy of Real-time Ultrasound-Guided Seldinger Technique versus Pre-scan Marking for Small-Bore Chest Tube Insertion in the Intensive Care Unit: A Retrospective Cohort Study
Scientific Title:Acronym
Real-time US vs Pre-scan for ICU Chest Tube Insertion
Region
| Japan |
Condition
Condition
Pleural effusion
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate whether the real-time ultrasound-guided Seldinger technique significantly reduces procedure-related mechanical complications (pneumothorax, hemorrhagic complications, and organ injury) and improves catheter placement accuracy and oxygenation compared to the conventional pre-scan marking technique in adult ICU patients requiring small-bore chest tube insertion.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite incidence of procedure-related mechanical complications (pneumothorax, hemorrhagic complications, and organ injury) within 24 hours post-procedure.
Key secondary outcomes
- Physiological efficacy at 24 hours post-procedure: Achievement rate of clinical improvement in oxygenation and total drainage volume.
- Catheter placement accuracy: Success rate of optimal positioning based on post-procedural imaging (CT and chest X-ray).
- Early procedural failure (within 24 hours post-procedure): Incidence of unplanned additional interventions (re-insertion or adjustment) due to malposition.
- Late-onset complications: Incidence of drain-related pleural infection from 48 hours post-procedure.
- Clinical course and outcomes: Duration of drainage, ICU length of stay, and ICU mortality.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All consecutive procedures for pleural drainage in patients with pleural effusion (>=20 years old) admitted to the ICU. To eliminate confounding by catheter size, the primary analysis cohort is restricted to cases using small-bore devices (<=12Fr).
Key exclusion criteria
- Procedures performed outside the ICU.
- [For Real-time group] Non-standard patient positioning or use of non-specified devices.
- Pre-existing pneumothorax or suspected pre-existing hemothorax (trauma, post-CPR, acute aortic disease, etc.).
- Patients under ECMO management with systemic anticoagulation.
- Complex pleural effusions and lung abscesses with cavities.
- [For Pre-scan group] Cases initially screened for the Pre-scan group but documented as "real-time ultrasound-guided" in medical records.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Nakamura |
Organization
Aichi Medical University
Division name
Department of Anesthesiology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
nakamura.kento.163@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Nakamura |
Organization
Aichi Medical University
Division name
Department of Anesthesiology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
nakamura.kento.163@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics Committee, Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561-76-6776
amu_ethics@aichi-med-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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 10 | 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
None
IPD sharing Plan description
IPD sharing is not planned.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 07 | Day |
Date trial data considered complete
| 2026 | Year | 05 | Month | 08 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 10 | Day |
Other
Other related information
This is an exploratory retrospective observational study involving consecutive patients who underwent pleural drainage in our Intensive Care Unit (ICU) between January 2022 and December 2025. Complete case analysis will be applied for missing data.
[Basic Analysis and Effect Size]
Continuous variables will be analyzed using the Student's t-test or Mann-Whitney U test, depending on the data distribution. Categorical variables will be compared using the Chi-square test or Fisher's exact test. Odds ratios (ORs) and 95% confidence intervals (CIs) will be calculated for the primary and secondary outcomes.
[Subgroup and Sensitivity Analyses]
To avoid overfitting in multivariate models, we will alternatively perform subgroup analyses based on clinical factors (e.g., severity scores, patient characteristics). The heterogeneity of treatment effects will be evaluated using P for interaction. In addition, sensitivity analyses will be conducted to assess and eliminate potential confounding from procedural factors (e.g., differences in devices) and concurrent treatments.
Management information
Registered date
| 2026 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070003
