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

NCT07634783 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation Weaning From Mechanical Ventilation Extubation Failure Critical Illness

Interventions

DIAGNOSTIC_TEST

Delta Pocc Measurement During Spontaneous Breathing Trial

Delta airway occlusion pressure deflection will be measured during a standardized spontaneous breathing trial using pressure support ventilation of 8 cmH2O and PEEP of 0 cmH2O. Delta Pocc will be obtained through a brief expiratory occlusion maneuver and analyzed as a non-invasive physiological estimate of inspiratory effort and dynamic respiratory stress. The measurement will not replace clinical judgment or modify standard extubation decisions.

Sponsors & Collaborators

  • Sanatorio Parque, Argentina

    lead OTHER

Principal Investigators

  • Gabriel A Musso, PT, MSc · Sanatorio Parque

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Argentina

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 NCT07634783 on ClinicalTrials.gov