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Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study

Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study - Impact of mechanical ventilation strategy with electrical impedance tomography in patients at high-risk of postoperative pulmonary complications: A randomized clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055677
Enrollment
400
Registered
2024-10-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 &gt

Interventions

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 o
=0.6 at admission and oxygenation decreases - Clinician discretion for settings if spontaneous breathing within 4 hours Non-EIT Group (Control): - Mode: A/C (volume or pressure) - Tidal volume: 6-1
=300 mmHg: PEEP 5 cmH2O PaO2/FiO2 200-299 mmHg: PEEP 6-10 cmH2O PaO2/FiO2 &lt
200 mmHg: PEEP 10-15 cmH2O - Maintain set PEEP for &gt
=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
5.0 cmH2O at allocation - Clinician discretion for settings if spontaneous breathing within 4 hours

Sponsors

The University of Osaka Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients with a postoperative pulmonary complication severity score >= 3

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTakeshi Yoshida

The University of Osaka Hospital Department of Anesthesiology and Intensive Care Medicine, Graduate School of Medicine

takeshiyoshida@hp-icu.med.osaka-u.ac.jp06-6879-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026