UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055086 |
|---|---|
| Receipt number | R000062687 |
| Scientific Title | IMPACT OF MECHANICAL VENTILATION STRATEGY WITH ELECTRICAL IMPEDANCE TOMOGRAPHY IN PATIENTS AT HIGH RISK OF POSTOPERATIVE PULMONARY COMPLICATIONS: A FEASIBILITY STUDY |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2024/08/07 11:09:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
IMPACT OF MECHANICAL VENTILATION STRATEGY WITH ELECTRICAL IMPEDANCE TOMOGRAPHY IN PATIENTS AT HIGH RISK OF POSTOPERATIVE PULMONARY COMPLICATIONS: A FEASIBILITY STUDY
Acronym
IMPACT OF MECHANICAL VENTILATION STRATEGY WITH ELECTRICAL IMPEDANCE TOMOGRAPHY IN PATIENTS AT HIGH RISK OF POSTOPERATIVE PULMONARY COMPLICATIONS: A FEASIBILITY STUDY
Scientific Title
IMPACT OF MECHANICAL VENTILATION STRATEGY WITH ELECTRICAL IMPEDANCE TOMOGRAPHY IN PATIENTS AT HIGH RISK OF POSTOPERATIVE PULMONARY COMPLICATIONS: A FEASIBILITY STUDY
Scientific Title:Acronym
IMPACT OF MECHANICAL VENTILATION STRATEGY WITH ELECTRICAL IMPEDANCE TOMOGRAPHY IN PATIENTS AT HIGH RISK OF POSTOPERATIVE PULMONARY COMPLICATIONS: A FEASIBILITY STUDY
Region
| Japan |
Condition
Condition
Patients at high risk for postoperative plumonary complications
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many patients admitted to the postoperative ICU require ventilator ventilation. Still, inappropriate PEEP (Positive End-Expiratory Pressure) settings are known to cause dorsal atelectasis and ventral hyperinflation, resulting in inhomogeneous ventilation distribution. EIT (Electrical Impedance Tomography) is a bedside device that noninvasively monitors ventilation distribution over time without x-ray exposure. Our studies using EIT have shown that patients at high risk for postoperative pulmonary complications exhibit phenotype 1 (ventral dominance), phenotype 2 (uniform ventilation distribution), and phenotype 3 (dorsal dominance) ventilation patterns. Furthermore, in the PEEP setting based on clinical judgment, approximately 60% of patients had heterogeneous ventilation distribution (phenotype 1, phenotype 3), and there was an association between heterogeneous ventilation distribution and increased postoperative pulmonary complications and prolonged ventilation. Therefore, ventilator management with a more uniform distribution ventilation may improve prognosis compared to conventional PEEP/FiO2 table. This study aimed to determine whether EIT-based PEEP settings are effective in achieving uniform ventilation distribution in patients at high risk for postoperative pulmonary complications who present with heterogeneous ventilation distribution.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients whose phenotype 1 or 3 changes to phenotype 2 by PEEP determination method using EIT (percentage of patients whose ventilation distribution is homogenized)
Key secondary outcomes
Ventilation distribution after 4 hours of PEEP determination using EIT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
For patients with EIT and heterogeneous ventilation distribution (phenotype 1, phenotype 3) , PEEP setting is performed using EIT-guided ventilation distribution as an index.
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 over 18 years of age who have undergone surgical procedures
Patients under ventilatory management upon return to the ICU after surgery
Patients at high risk for postoperative pulmonary complications
Heterogeneous ventilation distribution (phenotype 1 DFV<0.5 or phenotype 3 DFV>=0.6) within 12 hours after ICU admission
Key exclusion criteria
Patients with spinal or pelvic instability due to fractures.
Patients with implantable cardioverter-defibrillators or implantable pacemakers.
Patients with preoperative skin lesions, such as blisters, between the 4th and 5th ribs where the EIT belt is worn.
Patients with do-not-resuscitate (DNR) orders.
Patients on home ventilatory management before surgery.
Patients undergoing tracheostomy.
Patients with low cardiac function before surgery (left ventricular ejection fraction of 40% or less, or NYHA III or higher by echocardiography).
Patients with preoperative chest CT scan or chest x-ray showing a bra or other contraindication to the recruitment maneuver.
Patients with a persistent air leak from the thoracic drain or suspected intraoperative lung injury, contraindicating the recruitment maneuver.
Patients with an artificial heart.
Patients with extracorporeal membrane oxygenation (ECMO) support (either veno-venous (VV) or veno-arterial (VA)).
Patients with a history of neuromuscular disease.
Pregnant women.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
5650871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6879-5820
t.hoshino.mie@gmail.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Hoshino |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
5650871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6879-5820
Homepage URL
https://www.med.osaka-u.ac.jp/pub/anes/intensive_care3.html
t.hoshino.mie@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethical Review Board Osaka University Hospital
Address
Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita City, Osaka, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 26 | 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
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
