Acute Respiratory Distress Syndrome (ARDS), Intra-abdominal Hypertension
Conditions
Brief summary
This study aims to adopt a randomized crossover design to compare the effects of end-expiratory transpulmonary pressure-guided PEEP titration and EIT-guided PEEP titration on local lung ventilation, shunt, dead space, and ventilation-perfusion (V/Q) ratio as monitored by EIT. Additionally, it will evaluate their impact on respiratory mechanics, chest wall mechanics, mechanical power, hemodynamics, gas exchange, intra-abdominal pressure. By identifying an optimal PEEP titration strategy for patients with intra-abdominal hypertension (IAH) and acute respiratory distress syndrome (ARDS), this study aims to develop a mechanical ventilation approach that maintains lung recruitment and minimizes lung injury while avoiding adverse effects on other organs. The findings could facilitate the clinical application of this strategy and benefit a broader population of patients with IAH and ARDS.
Interventions
OTHERTranspulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients
After completion of baseline ventilation and lung recruitment, the ventilator was switched to volume-controlled mode, and PEEP was set using an empirical PL-FiO₂ table, with the goal of maintaining end-expiratory transpulmonary pressure (PL) \> 0 cmH₂O and end-inspiratory PL ≤ 20 cmH₂O.
OTHEREIT-Guided PEEP Titration in IAH and ARDS Patients
After completion of baseline ventilation and lung recruitment, the ventilator was switched to pressure-controlled mode with a pressure control (PC) of 15 cmH₂O. PEEP was initially set at 24 cmH₂O and then gradually decreased in steps of 3 cmH₂O, with each PEEP level maintained for 2 minutes, down to a minimum of 3 cmH₂O, using the ODCL method for PEEP titration.
Sponsors
XiaoJing Zou,MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age: 18-80 years; 2. meets IAH ≥12 mmHg; 3. meets the diagnostic criteria of the Berlin definition of ARDS; 4. PaO2/FiO2 ≤ 200; 5. within 36 hours of invasive mechanical ventilation; 6. patients or their family members were consulted, agreed to participate in the trial, and signed an informed consent form.
Exclusion criteria
1. Age \<18 years or age \>80 years; 2. uncorrected shock of any type; 3. chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia; 4. pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery; 5. non-invasive ventilation or transnasal high-flow oxygen; 6. with relevant contraindications to the application of EIT (large chest skin injuries, infections, pacemaker implanters, in vivo automatic defibrillator implantation, etc.) pneumothorax, mediastinal emphysema, massive pleural effusion; 7. oesophageal obstruction, oesophageal perforation, severe oesophageal variceal bleeding, upper gastrointestinal surgery, and other factors that make it impossible to place an oesophageal pressure catheter; 8. diaphragmatic hernia, thoracic deformity; patients with obvious pulmonary hernias; 9. prolongation of prothrombin time (PT), activated partial thromboplastin time (APTT) to two times the high limit of normal values or with active bleeding in the nasopharynx; 10. severe neurological disease: intracranial hypertension or neuromuscular disease, etc; 11. pregnant and lactating women; 12. patients to be treated with ECMO; 13. re-admission to the ICU of patients who have already been included in this study, or who are participating in other clinical studies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the optimal PEEP titrated based on end-expiratory transpulmonary pressure and that guided by EIT | After PEEP titration |
Secondary
| Measure | Time frame |
|---|---|
| Electrical impedance tomography (EIT) parameters included: Global inhomogeneity (GI) index、Center of ventilation (CoV)、Shunt fraction、V/Q matching ,and so on | 30-minute ventilation after PEEP titration |
| Clinical respiratory and hemodynamic parameters | 30-minute ventilation after PEEP titration |
Countries
China
Outcome results
None listed