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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

NCT06697717 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-21

No results posted yet for this study

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)

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • XiaoJing Zou,MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06697717 on ClinicalTrials.gov