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RECRUITING
NCT06921655
NA

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

Sponsor: Centre for Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-10-08

Completion Date

2027-04-08

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

PROCEDURE

Variation 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