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 | Recruiting

• 1 other identifier: PEEP20240921
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

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

  After PEEP titration

Secondary Outcomes (2)

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

  30-minute ventilation after PEEP titration

• Clinical respiratory and hemodynamic parameters

  30-minute ventilation after PEEP titration

Study Arms (2)

Transpulmonary Pressure-Guided PEEP Titration

EXPERIMENTAL

Other: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients

EIT-Guided PEEP Titration

EXPERIMENTAL

Other: EIT-Guided PEEP Titration in IAH and ARDS Patients

Interventions

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.

Transpulmonary Pressure-Guided PEEP Titration

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 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.

EIT-Guided PEEP Titration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• XiaoJing Zou,MD: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Xiaojing Professor

CONTACT

13995518630; 13995518630@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)