Actively Recruiting
Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
Led by Centre for Medical Sciences · Updated on 2026-02-03
36
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 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 will not qualify if you...
- Age under 18 years
- Known neurological or neuromuscular disorders affecting diaphragm function
- Chronic Obstructive Pulmonary Disease (COPD) or hypercapnic respiratory failure
- Psychomotor agitation or inadequate sedation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy
Trento, Trento, Italy, 38122
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
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