Patients Invasively Ventilated Under Pressure Support Ventilation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTClinical evaluation of the respiratory effort by the physician and nurse in charge of the patient
The clinician and the nurse in charge of the patient evaluate the respiratory effort
Sponsors
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients mechanically ventilated for at least 48 hours * switched to pressure support ventilation within the previous 48 hours
Exclusion criteria
* pregnancy * legal protection status * refusal by the patient or relatives to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance (sensitivity, specificity) of the clinical evaluation in diagnosing excessive respiratory effort and insufficient respiratory effort | Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Day 28 | Mortality |
Countries
France
Outcome results
None listed