UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055677 |
|---|---|
| Receipt number | R000063624 |
| Scientific Title | Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2026/02/05 13:31:58 |
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Basic information
Public title
Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study
Acronym
OSACA EIT TRIAL
Scientific Title
Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study
Scientific Title:Acronym
Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study
Region
| Japan |
Condition
Condition
Adult patients (18 years or older) undergoing elective cardiac surgery, requiring mechanical ventilation upon ICU admission postoperatively, and at high risk for postoperative respiratory complications(ARISCAT score >= 45).
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many postoperative ICU patients require respiratory management with mechanical ventilation. However, it is known that inappropriate PEEP (Positive End-Expiratory Pressure) settings can cause dorsal atelectasis and ventral hyperinflation, leading to uneven ventilation distribution in the lungs. There is no established method for setting PEEP for patients requiring postoperative mechanical ventilation, and intensive care physicians typically set it empirically based on oxygenation.EIT (Electrical Impedance Tomography) is a device that can non-invasively monitor ventilation distribution in the lungs over time at the bedside without X-ray exposure. Our research using EIT has shown that in patients at high risk for postoperative respiratory complications, about 60% have uneven lung ventilation distribution with PEEP settings based on clinical judgment. We also found an association between uneven lung ventilation distribution and increased postoperative respiratory complications and prolonged mechanical ventilation time.
Therefore, the purpose of this study is to test the hypothesis that PEEP settings guided by EIT-based ventilation distribution indicators will result in decreased postoperative respiratory complication severity scores and shortened time to weaning from mechanical ventilation compared to conventional PEEP settings without EIT use in patients at high risk for postoperative respiratory complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Proportion of patients with a postoperative pulmonary complication severity score >= 3
Key secondary outcomes
1.Time to liberation from mechanical ventilation
Definition of liberation from mechanical ventilation: The point at which the patient survives and is free from mechanical ventilation for 48 hours (maximum 90 days)
2.Time to cessation of oxygen therapy
Definition of cessation of oxygen therapy: The point at which the patient survives and is free from oxygen therapy for 48 hours (maximum 90 days)
3.Reintubation rate
4.Incidence of barotrauma
5.ICU length of stay
6.Hospital length of stay
7.Adverse events during ICU stay
8.Measured tidal volume (at allocation, 4 hours after allocation, immediately before extubation)
9.Measured respiratory rate (at allocation, 4 hours after allocation, immediately before extubation)
10.PEEP (at allocation, 4 hours after allocation, immediately before extubation)
11.Plateau pressure (at allocation, 4 hours after allocation, immediately before extubation)
12.Driving pressure (at allocation, 4 hours after allocation, immediately before extubation)
13.Static respiratory system compliance (at allocation, 4 hours after allocation, immediately before extubation)
14.A postoperative pulmonary complication severity score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EIT Use Group (Intervention):
- Mode: A/C
- Tidal volume: 6-10 mL/predicted body weight
- Respiratory rate: Target PaCO2 35-45 mmHg
- FiO2: Target SpO2 90-99%
- PEEP: Adjust for Dorsal Fraction of Ventilation (DFV) 0.5-0.59
PEEP setting:
1. Recruitment: 30 cmH2O for 20s (PEEP 15 cmH2O, inspiratory pressure 15 cmH2O)
2. Decrease PEEP by 2 cmH2O every 30s-2min from 15 cmH2O until DFV 0.5-0.59
3. PEEP range: 15-3 cmH2O
4. Adjust hourly if needed
Notes:
- Allow high PEEP if DFV >=0.6 at admission and oxygenation decreases
- Clinician discretion for settings if spontaneous breathing within 4 hours
Interventions/Control_2
Non-EIT Group (Control):
- Mode: A/C (volume or pressure)
- Tidal volume: 6-10 mL/predicted body weight
- Respiratory rate: Target PaCO2 35-45 mmHg
- FiO2: Target SpO2 90-99%
- PEEP:
PaO2/FiO2 >=300 mmHg: PEEP 5 cmH2O
PaO2/FiO2 200-299 mmHg: PEEP 6-10 cmH2O
PaO2/FiO2 <200 mmHg: PEEP 10-15 cmH2O
- Maintain set PEEP for >=4 hours
- Adjust other settings as needed within 4 hours
- Clinician discretion for spontaneous breathing
- Allow high PEEP for hemostasis pre-allocation
- Adjust PEEP if hemodynamically unstable
Notes:
- Set PEEP per criteria if >5.0 cmH2O at allocation
- Clinician discretion for settings if spontaneous breathing within 4 hours
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.Patients aged 18 years or older who have undergone cardiac surgery
2.Patients receiving mechanical ventilation upon admission to the ICU after surgery
3.Patients at high risk for postoperative pulmonary complications*
*Definition of high-risk patients for postoperative pulmonary complications: ARISCAT score of 45 points or higher
Key exclusion criteria
Exclusion criteria:
1. Patients with contraindications for EIT:
- Unstable spine or pelvis due to fractures
- Implanted defibrillators or pacemakers
- Skin lesions at the 4th-5th intercostal space where the EIT belt is placed
- Patients who are unable to wear the EIT belt (if they have other items attached to the belt after thoracic and abdominal vascular replacement surgery)
2. Patients with DNR (do-not-resuscitate) orders
3. Patients on home mechanical ventilation pre-operatively
4. Patients with tracheostomy
5. Patients not planned for extubation in the ICU for elective surgery the following day or later
6. Patients with pre-existing low cardiac function (left ventricular ejection fraction <= 40% on echocardiography or NYHA class III or higher)
7. Patients with bullae identified on pre-operative chest CT or X-ray, contraindicating recruitment maneuvers
8. Patients with continuous air leaks from chest drains or suspected intraoperative lung injury, contraindicating recruitment maneuvers
9. Patients with ventricular assist devices
10. Patients on extracorporeal membrane oxygenation (VV or VA)
11. Patients with a history of neuromuscular diseases
12. Pregnant women
13. Patients who have undergone lung resection or lung transplantation
14. Patients undergoing emergency surgery where obtaining consent is difficult
15. Patients who are likely to be extubated within 4 hours after ICU admission
16. Patients whose hemodynamic stability cannot be confirmed within 12 hours after admission to the ICU
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine, Graduate School of Medicine, Osaka University
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine, Graduate School of Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
Homepage URL
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Osaka University Hospital
Address
Research Support Section, Education and Research Support Division Osaka University Hospital 4th Floor, Center for Medical Innovation and Translational Research Building 2-2 Yamadaoka, Suita City
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
大阪大学医学部附属病院(大阪府)、大阪医科薬科大学病院（大阪府）、八尾徳洲会総合病院（大阪府）、神戸大学医学部附属病院（兵庫県）、広島大学病院（広島県）、藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063624
