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Not Yet Recruiting NCT07697703

End-Expiratory Diaphragmatic Residual Contraction Index for Identifying Intrinsic PEEP and Assisting PEEP Titration: A Prospective Physiological Study

Conditions: Speckle Tracking, Diaphragm

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Sir Run Run Shaw Hospital

Summary

This study proposes the End-expiratory Diaphragmatic Residual Contraction (EDRC) index to quantify residual diaphragmatic activity at end-expiration during Pressure Support Ventilation (PSV) mode. The study aims to validate the relationship between EDRC and dynamic intrinsic PEEP (PEEPi), triggering load, patient-ventilator asynchrony, and PEEP responsiveness through a brief, standardized PEEP titration trial conducted within a clinically safe range. This will provide a basis for subsequent individualized PEEP setting guided by EDRC.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years. Patients receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode. Clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or experiencing difficult weaning from mechanical ventilation. Presence of an indwelling esophageal balloon catheter (for reference standard measurements). Provision of written informed consent from the patient or legally authorized representative. Exclusion Criteria: * Pregnancy or lactation. Known esophageal diseases (e.g., esophageal varices, strictures, recent esophageal surgery) or contraindications to esophageal catheter placement. Severe hemodynamic instability (e.g., requiring high-dose vasoactive support, uncontrolled arrhythmias). Severe hypoxemia (PaO2/FiO2 \< 100 mmHg) or severe hypercapnia with hemodynamic compromise at baseline. Conditions precluding ultrasound assessment of the diaphragm (e.g., extensive chest wall trauma, large pleural effusion, severe subcutaneous emphysema). Active spontaneous breathing with severe patient-ventilator asynchrony that cannot be stabilized during the trial. Anticipated extubation or withdrawal of life-sustaining treatment within the next 24 hours. Participation in another interventional clinical trial within the last 30 days.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07697703). StuddyBuddy aggregates publicly available trial information.