Ventilator measurements to predict successful breathing off the ventilator

Evaluation of Mechanical Power to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study

This study will see if ventilator measurements—mechanical power, airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)—can identify adult ICU patients who can be safely weaned from mechanical ventilation.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Academic / other)
• Locations: 1 site (Istanbul)
• Trial ID: NCT07268989 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational single-center study enrolling mechanically ventilated adult ICU patients in Istanbul. When patients meet clinical weaning criteria and are hemodynamically stable, ventilator-derived parameters (mechanical power, P0.1, NIF, RSBI, and the MP/NIF ratio) will be measured at the bedside within two hours. Participants will be monitored for 48 hours after extubation to determine weaning success, defined as no reintubation, no need for non-invasive ventilation, and no requirement for high-flow oxygen. No interventions beyond standard ICU care will be performed; demographic, severity scores, ventilator settings, and post-extubation outcomes will be recorded.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) intubated at least 24 hours in the ICU who meet standard weaning criteria, are hemodynamically stable, and can provide informed consent or have a legal representative do so.

Not a fit: Patients unlikely to benefit include those under 18, pregnant patients, tracheostomized patients, individuals with neuromuscular diseases, or those who do not meet weaning criteria or are hemodynamically unstable.

Why it matters

Potential benefit: If successful, these measurements could help clinicians better predict who can be safely extubated, potentially reducing prolonged ventilation and reintubation rates.

How similar studies have performed: Prior work has shown that RSBI and NIF can provide some predictive value for weaning, while using mechanical power and the MP/NIF ratio for this purpose is relatively new and less well validated.

Eligibility criteria

Inclusion Criteria:

\-

Age ≥ 18 years (adult patient population)

* Patients receiving invasive mechanical ventilation in the intensive care unit
* Having been intubated for at least 24 hours
* Patients for whom the clinical team has decided extubation and who meet the following weaning criteria:
* Stable respiratory parameters (FiO₂ ≤ 40%, PEEP ≤ 5 cmH₂O, SpO₂ ≥ 92%)
* Hemodynamic stability (no inotropic support or minimal/stable dose)
* Appropriate neurological status (able to follow commands)
* Stable acid-base balance
* Adequate secretion control
* Technically suitable ventilator and measurement conditions
* Written informed consent obtained from the patient or legal representative

Exclusion Criteria:

* Patients with any of the following conditions will be excluded:

and

* Individuals under 18 years of age
* Pregnant patients
* Patients who do not meet the weaning criteria
* Tracheostomized patients
* Neuromuscular diseases (e.g., Guillain-Barré syndrome, Duchenne muscular dystrophy, etc.)
* Technical inadequacy preventing correct ventilator measurements
* Significant asynchrony (e.g., auto-PEEP, double triggering, ineffective triggering, cycle asynchrony, auto-triggering)
* Patients without an extubation plan or those receiving palliative care
* RASS ≤ -2 (excessive sedation) for PSV mode measurements
* RASS ≥ +2 (agitation) for PSV-CPAP mode measurements
* Patients with delirium for PSV-CPAP mode measurements
* Patients who cannot provide consent, have no legal representative, or whose representative refuses consent

Where this trial is running

Istanbul

• Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital — Istanbul, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Anıl Berkay Balıtatlı

Conditions Weaning Mechanical Ventilation; Mechanical Power; Negative Inspiratory Force; Airway Occlusion Pressure; Mechanical power; Weaning mechanical ventilation; Negative inspiratory; Airway occlusion pressure