About this trial
The TEMA study (Targeting prEssure-Muscle-index to avoid ventilatory over-Assistance during pressure support ventilation) is a prospective, interventional crossover trial investigating the relationship between pressure support (PS) and tidal volume (Vt) in ICU patients with acute hypoxemic respiratory failure (AHRF) receiving pressure support ventilation (PSV). The study aims to assess whether the Pressure-Muscle Index (PMI)-a marker derived from the difference between plateau and peak inspiratory pressure-can help identify the optimal level of ventilatory assistance, preventing over-assistance and its associated complications such as diaphragm atrophy and patient self-inflicted lung injury (P-SILI). By exploring the sigmoidal relationship between PS and Vt, the study seeks to define a physiological threshold (PMI=0) that may serve as a personalized target for PSV titration.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Mechanically ventilated in the ICU
Diagnosis of Acute Hypoxemic Respiratory Failure (AHRF)
Normocapnia or non-severe hypercapnia
Disqualifiers
Age < 18 years
Known neurological or neuromuscular disorders affecting diaphragm function
Chronic Obstructive Pulmonary Disease (COPD) or hypercapnic respiratory failure
Psychomotor agitation or inadequate sedation
Trial design
Treatments tested in this trial
- Variation of Pressure Support Levels
Treatment groups
7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Centre for Medical Sciences
Lead sponsor
Università degli Studi di Trento
Sponsor institution