Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Centre for Medical Sciences

Conditions:

Acute Hypoxemic Respiratory Failure

Mechanical Ventilation Complication

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 relationshi...

Detailed Description

The TEMA study is a prospective, interventional crossover trial designed to explore the physiological relationship between levels of pressure support (PS) and tidal volume (Vt) in mechanically ventila...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT06921655

Start Date

June 1 2025

End Date

June 1 2027

Last Update

April 18 2025

Active Locations (1)

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1

Centre for Medical Sciences

Trento, Italy, 38122