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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre for Medical Sciences

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

36 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Centre for Medical Sciences

Lead sponsor

Università degli Studi di Trento

Sponsor institution