Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation

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.

NCT Number	NCT06921655
Lead Sponsor	Centre for Medical Sciences
Conditions	Acute Hypoxemic Respiratory Failure, Mechanical Ventilation Complication
Enrollment	36 participants
Start Date	2025-10-08
Primary Completion	2028-06-15 (estimated)
Study Completion	2028-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-05