Comparing two methods for adjusting breathing support in patients with severe lung and abdominal conditions

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

This study is testing two different ways to adjust breathing support for patients with severe lung and stomach problems to see which method helps them breathe better and stay healthy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06697717 on ClinicalTrials.gov

What this trial studies

This study compares two methods for adjusting positive end-expiratory pressure (PEEP) in patients suffering from intra-abdominal hypertension and acute respiratory distress syndrome. It utilizes a randomized crossover design to evaluate the effects of end-expiratory transpulmonary pressure-guided PEEP titration versus electrical impedance tomography (EIT)-guided PEEP titration. The study will assess various respiratory and hemodynamic parameters to identify the optimal PEEP strategy that minimizes lung injury while maintaining organ function. The goal is to enhance mechanical ventilation approaches for these critically ill patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have intra-abdominal hypertension and meet the criteria for acute respiratory distress syndrome.

Not a fit: Patients under 18 or over 80 years old, those with chronic lung or heart conditions, or those with recent lung surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mechanical ventilation strategies that enhance lung function and reduce complications in patients with intra-abdominal hypertension and ARDS.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing ventilation strategies for critically ill patients.

Eligibility criteria

Inclusion Criteria:

1. age: 18-80 years;
2. meets IAH ≥12 mmHg;
3. meets the diagnostic criteria of the new global definition of ARDS in the 2023 edition;
4. PaO2/FiO2 ≤ 150;
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;

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaojing Professor

Conditions Intra-abdominal Hypertension; Acute Respiratory Distress Syndrome