RecruitingNCT07268989

Evaluation of Mechanical Power and Ventilator Parameters to Predict Weaning Success in the Intensive Care Unit

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


Sponsor

Anıl Berkay Balıtatlı

Enrollment

60 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are: Can the mechanical power (MP) value predict successful extubation? Do other respiratory parameters-airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)-provide additional prognostic value for weaning outcomes? Participants will: * Be adult ICU patients planned for weaning from mechanical ventilation. * Undergo bedside ventilatory assessment within 2 hours after meeting clinical weaning criteria. * Have the following respiratory parameters measured: MP, P0.1, NIF, and RSBI. * Be monitored for 48 hours after extubation to assess weaning success (defined as no need for reintubation, non-invasive ventilation, or high-flow oxygen support)


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • \-
  • 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 Criteria14

  • 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

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Interventions

DIAGNOSTIC_TESTMechanical power

Non-invasive bedside evaluation of respiratory load, neural drive, and inspiratory muscle capacity using mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI). • Measurements will be performed once within 2 hours prior to the extubation decision as part of routine ICU respiratory monitoring.


Locations(1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Turkey (Türkiye)

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NCT07268989


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