NCT06921655 Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
| NCT ID | NCT06921655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Medical Sciences |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2028-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-10-08 with a primary completion date of 2028-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Frequently Asked Questions
Who can join the NCT06921655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921655 currently recruiting?
Yes, NCT06921655 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre for Medical Sciences to inquire about joining.
Where is the NCT06921655 trial being conducted?
This trial is being conducted at Trento, Italy.
Who is sponsoring the NCT06921655 clinical trial?
NCT06921655 is sponsored by Centre for Medical Sciences. The trial plans to enroll 36 participants.