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

Recruiting now · Not applicable

Conditions studied: Acute Hypoxemic Respiratory Failure, Mechanical Ventilation Complication

In brief

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.

Key facts

Study ID

NCT06921655

Run by

Centre for Medical Sciences

People needed

36

Starts

2025-10-08

Expected to finish

2028-12-15

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Mechanically ventilated in the ICU
• Diagnosis of Acute Hypoxemic Respiratory Failure (AHRF)
• Normocapnia or non-severe hypercapnia
• Receiving Pressure Support Ventilation (PSV) for at least 24-72 hours
• Presence of an arterial line for blood gas sampling

You may not qualify if…

• 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

Where it is running

• Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy — Trento, Trento, Italy (enrolling)

Full record on ClinicalTrials.gov

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