UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063488 |
|---|---|
| Receipt number | R000072617 |
| Scientific Title | Diagnostic Accuracy of Flow-Limited Tidal Pressure-Volume Loops for Detecting Tidal Derecruitment in Mechanically Ventilated Patients |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/11/01 17:28:28 |
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Basic information
Public title
Diagnostic Accuracy of Flow-Limited Tidal Pressure-Volume Loops for Detecting Tidal Derecruitment in Mechanically Ventilated Patients
Acronym
PV Loop Derecruitment Study
Scientific Title
Diagnostic Accuracy of Flow-Limited Tidal Pressure-Volume Loops for Detecting Tidal Derecruitment in Mechanically Ventilated Patients
Scientific Title:Acronym
PV Loop Derecruitment Study
Region
| Japan |
Condition
Condition
Respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During a decremental PEEP trial, tidal pressure-volume loops are recorded with inspiratory flow limited to 2 and 5 L/min. In stage 1, regional pressure-impedance relationships measured by electrical impedance tomography (EIT) are used to identify findings indicating tidal recruitment/derecruitment. In stage 2, using these EIT findings as the reference, the ability of global tidal hysteresis at 2 L/min and 5 L/min to detect tidal recruitment/derecruitment is compared.
Basic objectives2
Others
Basic objectives -Others
Validity and detection performance of physiological indices
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Stage 1: whether the prespecified primary hypotheses in the statistical analysis plan are supported (PEEP dependence of EIT findings of tidal recruitment/derecruitment and their agreement with independent physiological indices). Stage 2: detection performance (sensitivity, specificity, AUC) of global tidal hysteresis at 2 L/min versus 5 L/min, using the EIT findings as the reference.
Key secondary outcomes
(1) Difference in hysteresis between the two flow conditions, and hysteresis normalized to predicted body weight. (2) Agreement of the pressure at linearization point (PLP) between conditions. (3) Knee point in the hysteresis trend during PEEP decrement. (4) Relationship between inspiratory stress rate and hysteresis. (5) Sensitivity analysis using the Mojoli 2026 threshold (1.4 mL/kg). (6) Detection accuracy against a decrease in respiratory system compliance of 1 mL/cmH2O or more per 2 cmH2O PEEP decrement. (7) Repeatability of measurements repeated under identical conditions. (8) Reversibility of regional indices at the PEEP set after the trial. (9) PEEP dependence of regional EIT indices (layer hysteresis, delta EELI, regional ventilation delay, silent spaces). (10) Presence and flow dependence of the inspiratory uncorking effect.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Odd-numbered participants (by order of consent): at each PEEP step, tidal PV loops are recorded in the order 2, 5, 2, 5 L/min inspiratory flow. The decremental PEEP trial starts at 20 cmH2O in patients judged recruitable by the recruitment-to-inflation ratio and at 14 cmH2O otherwise, decreasing by 2 cmH2O to 8 cmH2O, with at least 3 minutes at each step and simultaneous EIT recording. Loops at both flows are also recorded at the PEEP set after the trial.
Interventions/Control_2
Even-numbered participants: same as intervention 1, but in the order 5, 2, 5, 2 L/min.
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
(1) Age 18 years or older. (2) Receiving invasive mechanical ventilation. (3) Current PEEP of 8 cmH2O or higher. (4) Ventilated in pressure-controlled assist-control mode. (5) Passive ventilation or equivalent conditions allowing assessment. (6) Judged eligible for the maneuver by the principal investigator or attending physician. (7) Written informed consent from the patient or a legally authorized representative.
Key exclusion criteria
(1) Strong spontaneous breathing (P0.1 of 3 cmH2O or higher). (2) Large circuit leak (leak fraction above 20%). (3) Pneumothorax, bronchopleural fistula, or other conditions making interpretation of respiratory mechanics difficult. (4) Severe hemodynamic instability, such as increasing vasopressor dose. (5) Severe intracranial hypertension. (6) Any other condition judged inappropriate by the principal investigator or attending physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kazuma |
Organization
Sapporo Medical University
Division name
Department of Intensive Care Medicine
Zip code
060-8556
Address
South 1, West 17, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
b_days@msn.com
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Goto |
Organization
Sapporo Medical University
Division name
Department of Intensive Care Medicine
Zip code
0640805
Address
South 1, West 17, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
09033963679
Homepage URL
ygoto@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
YUYA GOTO
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
South 1, West 17, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ygoto@sapmed.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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072617
