An observational study in Patients Invasively Ventilated Under Pressure Support Ventilation, sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon · Observational
The aim of this study is to assess whether clinical evaluation can accurately estimate the level of respiratory effort in intubated ICU patients receiving pressure support ventilation.
Insufficient or excessive respiratory effort during assisted ventilation contributes to diaphragm injury and patient self-inflicted lung injury (P-SILI), both of which worsen outcomes. Patients in the transition phase from controlled ventilation to assisted modes are particularly vulnerable because persistent lung injury may drive elevated respiratory effort, pendelluft, and large swings in alveolar pressure. One of the main goals of assisted ventilation is therefore to maintain effort within a physiological range that avoids both over- and under-assistance.
During pressure support ventilation (PSV), direct measurement of respiratory effort requires esophageal pressure monitoring, which is rarely feasible in routine care. Other noninvasive approaches, such as diaphragm ultrasound, lack reproducibility and cannot provide continuous monitoring. Airway occlusion pressure has shown promise for identifying both insufficient and excessive effort, but its performance varies across ventilator models. Additional indices, such as the maximal negative swing of airway pressure during end-expiratory occlusion (∆Pocc), or the pressure-muscle index (PMI), are limited by ventilator constraints.
In clinical practice, respiratory effort is usually judged clinically at the bedside. However, the accuracy of clinical examination for detecting abnormal effort has never been validated. The investigators hypothesize that bedside clinical assessment is unreliable and may expose patients to inappropriate levels of assistance. The primary aim of this investigation was to determine the accuracy of clinical examination in diagnosing abnormal respiratory effort during PSV.
Centre Hospitalier Saint Joseph Saint Luc de Lyon is the lead sponsor of 20 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
). Adult patients mechanically ventilated for at least 48 hours were eligible if switched to pressure support ventilation within the previous 48 hours. Exclusion criteria were pregnancy, legal protection status, and refusal by the patient or relatives to participate
Exclusion Criteria:
The clinician and the nurse in charge of the patient evaluate the respiratory effort
Diagnostic performance (sensitivity, specificity) of the clinical evaluation in diagnosing excessive respiratory effort and insufficient respiratory effort
The physician in charge of the patient will be asked to categorize the patient respiratory effort as normal, insufficient or excessive, based on his/her clinical evaluation. Esophageal pressure will be recorded at the same time, using an esophageal catheter. Esophageal pressure time product will then be computed and considered the reference standard for respiratory effort quantification. Sensitivity and Specificity of the clinical evaluation to diagnose excessive or insufficcient effort will be computed
Time frame: Baseline
Mortality
Mortality
Time frame: Day 28
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Saint Joseph Saint Luc de Lyon