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Completed

NCT Number: NCT06697717

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Union Hospital

Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age: 18-80 years;
  • meets IAH ≥12 mmHg;
  • meets the diagnostic criteria of the Berlin definition of ARDS;
  • PaO2/FiO2 ≤ 200;
  • 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 criteria

  • 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;

Treatment and study plan

Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients

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 in IAH and ARDS Patients

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 30 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.

Primary outcomes

  1. Difference between the optimal PEEP titrated based on end-expiratory transpulmonary pressure and that guided by EIT

    Time frame: After PEEP titration

Secondary outcomes

  1. Electrical impedance tomography (EIT) parameters included: Global inhomogeneity (GI) index、Center of ventilation (CoV)、Shunt fraction、V/Q matching ,and so on

    Time frame: 30-minute ventilation after PEEP titration

  2. Clinical respiratory and hemodynamic parameters

    Time frame: 30-minute ventilation after PEEP titration

Sponsors and collaborators

Lead sponsor

XiaoJing Zou,MD

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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