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RecruitingNot ApplicableNCT06921655

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

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

Sponsor

Centre for Medical Sciences

Enrollment

36 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Mechanical Ventilation ComplicationAcute Hypoxemic Respiratory Failure

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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

Exclusion Criteria4

  • 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
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Interventions

PROCEDUREVariation of Pressure Support Levels

Patients will undergo six randomized PS levels (+2, +4, +6 cmH₂O above and -2, -4, -6 cmH₂O below PSPMI=0).

Locations(1)

Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy

Trento, Trento, Italy

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NCT06921655

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