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

UMIN ID: UMIN000055677

Registered date:01/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Adult patients (18 years or older) undergoing elective surgery, requiring mechanical ventilation upon ICU admission postoperatively, and at high risk for postoperative respiratory complications(ARISCAT score >= 45).
• Date of first enrollment: 2024/11/01
• Target sample size: 260
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

EIT Use Group (Intervention): - Mode: A/C - Tidal volume: 6-8 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 If DFV >=0.6 at admission, skip recruitment. Decrease PEEP by 2 cmH2O until DFV 0.5-0.59. - 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: - Allow high PEEP if DFV >=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: 6-8 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

Outcome(s)

• Primary Outcome: Proportion of patients with a postoperative pulmonary complication severity score >= 3
• Secondary Outcome: 1.Time to liberation from mechanical ventilation 2.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) 3.Time to cessation of oxygen therapy 4.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) 5.Reintubation rate 6.Incidence of barotrauma 7.ICU length of stay 8.Hospital length of stay 9.Adverse events during ICU stay 10.Measured tidal volume (at allocation, 4 hours after allocation, immediately before extubation) 11.Measured respiratory rate (at allocation, 4 hours after allocation, immediately before extubation) 12.PEEP (at allocation, 4 hours after allocation, immediately before extubation) 13.Plateau pressure (at allocation, 4 hours after allocation, immediately before extubation) 14.Driving pressure (at allocation, 4 hours after allocation, immediately before extubation) 15.Static respiratory system compliance (at allocation, 4 hours after allocation, immediately before extubation)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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 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

Related Information

• Primary Sponsor: Osaka University Hospital
• Source(s) of Monetary Support: None