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

NCT07268989 | Recruiting

• 1 other identifier: Mechanical Power
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Weaning Mechanical Ventilation; Mechanical Power; Negative Inspiratory Force; Airway Occlusion Pressure

Keywords

Mechanical power; Weaning mechanical ventilation; Negative inspiratory; Airway occlusion pressure

Outcome Measures

Primary Outcomes (1)

• Mechanical Power (MP)

  Mechanical Power (MP), a ventilator-derived estimate of the total mechanical energy transferred to the respiratory system per unit time, will be measured prior to planned extubation and evaluated in relation to extubation outcomes

  48 hour

Secondary Outcomes (4)

• Airway Occlusion Pressure at 100 ms (P0.1)

  48 hour

• Negative Inspiratory Force (NIF)

  48 hour

• Rapid Shallow Breathing Index (RSBI)

  48 hour

• Mechanical Power to Negative Inspiratory Force Ratio (MP/NIF Ratio)

  48 hour

Study Arms (1)

Mechanically Ventilated ICU Patients Undergoing Weaning

Adult patients receiving mechanical ventilation in the intensive care unit (ICU) who meet clinical criteria for planned weaning and extubation. All patients will undergo bedside ventilator-based respiratory assessment to evaluate mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI) prior to extubation.

Diagnostic Test: Mechanical power

Interventions

Mechanical power DIAGNOSTIC_TEST

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.

Mechanically Ventilated ICU Patients Undergoing Weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who are receiving invasive mechanical ventilation in the intensive care unit (ICU) and are scheduled for planned extubation based on standard clinical weaning criteria. All participants must be hemodynamically stable and able to undergo bedside ventilator-based respiratory assessment, including mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI), prior to extubation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anıl Berkay Balıtatlı: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Anıl Berkay Balıtatlı

CONTACT

+905446519080; anilbbalitatli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician (Anesthesiology and Intensive Care)

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

TU (1)