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

NCT ID: NCT06697717

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-01

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, 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.

Conditions

Intra-abdominal Hypertension; Acute Respiratory Distress Syndrome (ARDS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Transpulmonary Pressure-Guided PEEP Titration

Group Type: EXPERIMENTAL

Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients

Intervention Type: OTHER

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.

EIT-Guided PEEP Titration

Group Type: EXPERIMENTAL

EIT-Guided PEEP Titration in IAH and ARDS Patients

Intervention Type: OTHER

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.

Interventions

Transpulmonary 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.

Intervention Type: OTHER

EIT-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.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XiaoJing Zou,MD

OTHER

Sponsor Role: lead

Responsible Party

XiaoJing Zou,MD

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaojing Professor

Role: CONTACT

13995518630@163.com

13995518630

Facility Contacts

Xiaojing Zou

Role: primary

13995518630@163.com

13995518630

Other Identifiers

PEEP20240921

Identifier Type: -

Identifier Source: org_study_id