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New treatment option for Acute Hypoxemic Respiratory Failure
Official title Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
ClinicalTrials.gov ID: NCT06921655
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Trento, Trento, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trento, Trento, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.