ARDS (Moderate or Severe)
Conditions
Brief summary
To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective mechanical ventilation strategy.
Interventions
DEVICETranspulmonary pressure guided mechanical ventilation strategy
Tidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O. In control group, PEEP was titrated using the low PEEP:FiO₂ table method.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. ARDS caused by pneumonia (New Global Definition of ARDS) 3. PaO2/FiO2≤200mmHg 4. Received invasive mechanical ventilation 5. Sign the informed consent form
Exclusion criteria
1. Invasive mechanical ventilation duration \> 48 hours 2. History of pulmonary hypertension caused by various reasons 3. Severe arrhythmia 4. BMI\>30kg/m2 5. Contraindications to inserting an esophageal catheter (including recent esophageal injury or surgery, severe coagulopathy (platelets \< 5×10⁹/L or INR \> 4) 6. Pregnant and lactating women 7. Lung transplant recipient 8. High-risk factors for increased intracranial pressure (including intracranial hemorrhage, cerebral contusion, cerebral edema, intracranial space-occupying lesions, etc.) 9. Active air leakage in the lungs (pneumothorax, mediastinal emphysema, bronchopleural fistula, air leakage from closed thoracic drainage tubes, etc.) 10. Neuromuscular disease 11. Already received salvage measures (iNO, ECMO, prone position, high-frequency oscillatory ventilation) 12. Severe liver failure 13. Participated in other ARDS-related studies within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of right ventricular involvement within 28 days | 28 days | Right ventricular involvement is defined as the presence of one of the following findings on transthoracic echocardiography: ACP: Right ventricular enlargement (RVED/LVED \> 0.6) with paradoxical septal motion; RVF: Right ventricular enlargement (RVED/LVED \> 0.6) accompanied by systemic venous congestion (CVP ≥ 8 mmHg), or if CVP is unavailable, inferior vena cava plethora; RVD: RV FAC \< 35%, or TAPSE ≤ 16 mm. |
Secondary
| Measure | Time frame |
|---|---|
| The respective incidence rates of ACP, RVF and RVD | 28 days |
| ICU mortality | 28 days and 60 days |
| invasive mechanical ventilation duration | 28 days |
| the number of participants receiving vasoactive agents | 28 days |
Countries
China
Contacts
CONTACTXiao Tang, MD
Outcome results
None listed