Using the Pressure-Muscle Index to avoid excessive ventilator support during pressure support ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy
  Trento, Trento, Italy Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Controlled versus standard oxygen therapy for ICU COPD with acute exacerbation

  This trial tests whether keeping oxygen levels at 88-92% helps ICU patients with an acute COPD flare more than keeping levels above 94%.

  Recruiting Hôpital Universitaire Taher Sfar · Mahdia, Mahdia Governorate and 1 other locations · NCT07842510

• Predicting HFNC Failure in Acute Hypoxemic Respiratory Failure using Metabolomics and Clinical Data

  This study tests whether metabolomic blood profiles combined with routine clinical data can predict which adults with acute hypoxemic respiratory failure on high-flow nasal cannula will fail and need escalation of care.

  Recruiting Hospital del Mar Research Institute (IMIM) · Barcelona, Catalonia · NCT07607080

• Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

  This study tests whether allowing spontaneous breathing or using controlled ventilation is better for adults with acute hypoxemic respiratory failure who need invasive mechanical ventilation.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07463885

• IL-6 guided dexamethasone or tocilizumab treatment for hospitalized acute hypoxemic respiratory failure

  This study will test whether measuring IL-6 to guide early treatment with dexamethasone or tocilizumab helps adults hospitalized with new acute hypoxemic respiratory failure.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07334379

• ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-Associated Pneumonia

  Researchers will test whether proteomic patterns in BAL fluid can identify subgroups of patients with suspected VAP on mechanical ventilation.

  Recruiting at 2 sites Region Skane · Limoges and 3 other locations · NCT07245888

• Using EIT to personalize PEEP during bariatric surgery

  This will test whether using electrical impedance tomography (EIT) to set personalized PEEP during laparoscopic bariatric surgery reduces postoperative lung complications compared with a fixed PEEP of 8 cmH2O in adults with obesity.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07207772

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.