RecruitingNot ApplicableNCT06697717

End-expiratory Transpulmonary Pressure-guided vs Electrical Impedance Tomography-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

End-expiratory Transpulmonary Pressure-guided vs EIT-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

Sponsor

XiaoJing Zou,MD

Enrollment

20 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Respiratory Distress Syndrome (ARDS)Intra-Abdominal Hypertension

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, abdominal perfusion pressure, and renal perfusion. 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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

age: 18-80 years;
meets IAH ≥12 mmHg;
meets the diagnostic criteria of the new global definition of ARDS in the 2023 edition;
PaO2/FiO2 ≤ 150;
within 36 hours of invasive mechanical ventilation;
patients or their family members were consulted, agreed to participate in the trial, and signed an informed consent form.

Exclusion Criteria13

Age \<18 years or age \>80 years;
uncorrected shock of any type;
chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia;
pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery;
non-invasive ventilation or transnasal high-flow oxygen;
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;
oesophageal obstruction, oesophageal perforation, severe oesophageal variceal bleeding, upper gastrointestinal surgery, and other factors that make it impossible to place an oesophageal pressure catheter;
diaphragmatic hernia, thoracic deformity; patients with obvious pulmonary hernias;
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;
severe neurological disease: intracranial hypertension or neuromuscular disease, etc;
pregnant and lactating women;
patients to be treated with ECMO;
re-admission to the ICU of patients who have already been included in this study, or who are participating in other clinical studies;

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 35 cmH₂O and then gradually decreased in steps of 3 cmH₂O, with each PEEP level maintained for 2 minutes, down to a minimum of 2 cmH₂O, using the ODCL method for PEEP titration.