Using the Pressure-Muscle Index to avoid excessive ventilator support during pressure support ventilation
Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure
This study will try using a Pressure-Muscle Index to find the right amount of pressure support for adults on mechanical ventilation for acute low-oxygen (hypoxemic) respiratory failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università degli Studi di Trento Academic / other |
| Locations | 1 site (Trento, Trento) |
| Trial ID | NCT06921655 on ClinicalTrials.gov |
What this trial studies
TEMA is a prospective, interventional crossover trial in an ICU that modulates seven levels of pressure support around a physiologic threshold defined by the Pressure-Muscle Index (PMI). At each support level investigators record tidal volume, respiratory rate, minute ventilation, PMI, and patient–ventilator asynchrony to map the sigmoidal relationship between pressure support and tidal volume. The PMI is calculated from the difference between plateau and peak airway pressures during an inspiratory occlusion and is used to identify the point (PMI=0) beyond which over-assistance and large tidal volumes occur. Patients who remain intubated have a second evaluation on day 4–6 to determine whether the PS–Vt relationship and PMI shift over time.
Who should consider this trial
Good fit: Adult ICU patients with acute hypoxemic respiratory failure who are on pressure support ventilation for 24–72 hours, are normocapnic or only mildly hypercapnic, and have an arterial line are the intended participants.
Not a fit: Patients with COPD or chronic hypercapnic respiratory failure, known neuromuscular disorders affecting the diaphragm, severe hypercapnia, or uncontrolled agitation (who are excluded) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, PMI-guided pressure support could help prevent excessive tidal volumes, reduce diaphragm atrophy and patient self-inflicted lung injury, and allow more personalized ventilator settings.
How similar studies have performed: Previous work supports limiting excessive tidal volumes and matching support to preserve diaphragm activity, but PMI-guided titration is a novel, physiologic approach that has not been validated in large clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Mechanically ventilated in the ICU 3. Diagnosis of Acute Hypoxemic Respiratory Failure (AHRF) 4. Normocapnia or non-severe hypercapnia 5. Receiving Pressure Support Ventilation (PSV) for at least 24-72 hours 6. Presence of an arterial line for blood gas sampling Exclusion Criteria: 1. Age \< 18 years 2. Known neurological or neuromuscular disorders affecting diaphragm function 3. Chronic Obstructive Pulmonary Disease (COPD) or hypercapnic respiratory failure 4. Psychomotor agitation or inadequate sedation
Where this trial is running
Trento, Trento
- Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy — Trento, Trento, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.