Clinical Trial

Delta Pocc During Spontaneous Breathing Trial to Predict Extubation Failure in Mechanically Ventilated Adults (DELTA-EXT)

Study acronym: DELTA-EXT
Not Yet Recruiting
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Summary
This prospective observational single-center study will evaluate whether dynamic respiratory stress estimated by delta airway occlusion pressure deflection (Delta Pocc) during a standardized spontaneous breathing trial can predict extubation failure in mechanically ventilated adult intensive care unit patients. Liberation from invasive mechanical ventilation is a critical step in ICU care. Although spontaneous breathing trials are routinely used to assess readiness for extubation, some patients may successfully complete the trial despite experiencing excessive respiratory effort and physiological stress, which may increase the risk of extubation failure. This study will include adult ICU patients who have received invasive mechanical ventilation for at least 24 hours and are considered ready for a spontaneous breathing trial according to the treating clinical team. During the trial, respiratory, ventilatory, and hemodynamic variables will be recorded at predefined time points, including measurements of Delta Pocc as a non-invasive estimate of inspiratory effort and dynamic stress. The primary outcome is extubation failure within 48 hours after extubation, defined as reintubation and/or the need for rescue non-invasive respiratory support due to post-extubation respiratory deterioration. The study aims to determine whether this physiological measurement may improve risk stratification during weaning and complement conventional clinical decision-making.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-02.
Trial Details
NCT Number NCT07634783
Lead Sponsor Sanatorio Parque, Argentina
Conditions Mechanical Ventilation Weaning From Mechanical Ventilation Extubation Failure Critical Illness
Enrollment 120 participants
Start Date 2026-08
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-25