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

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 after extubation)

Study Overview

• Status: Completed
• Conditions: Mechanical Power; Weaning Mechanical Ventilation; Negative Inspiratory Force; Airway Occlusion Pressure
• Intervention / Treatment: Diagnostic test: Mechanical power

Detailed Description

This is a prospective, observational, single-center study designed to investigate whether ventilator-derived physiological measurements can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of mechanical power (MP) in forecasting successful extubation.

Secondary objectives include the evaluation of additional respiratory parameters such as airway occlusion pressure (P0.1), negative inspiratory force (NIF), the rapid shallow breathing index (RSBI), and the mechanical power/negative inspiratory force ratio (MP/NIF). These parameters will be measured at the bedside within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.

All participants will be monitored for 48 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation after extubation during this period.

Data collection will include:

Respiratory measurements obtained from the ventilator: MP, P0.1, NIF, RSBI, and MP/NIF.

Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II scores, ventilator settings, and duration of mechanical ventilation.

Post-extubation follow-up: reintubation, non-invasive ventilation or high-flow oxygen use, SpO₂ values, blood gas analysis, and vital signs.

This study does not involve any interventions beyond standard ICU care. Ventilator-based respiratory assessments are routinely performed in ICU settings and pose no additional risk to participants.

The results may support the integration of load-drive-capacity assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34303
    • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 ≤ 50%, PEEP ≤ 7 cmH₂O, SpO₂ ≥ 92%)
• Hemodynamic stability (no inotropic support or minimal/stable dose)
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Occlusion Pressure at 100 ms (P0.1)	P0.1, an indicator of the patient's neural inspiratory drive that reflects the initial negative pressure generated at the start of a breath, will be measured prior to planned extubation and evaluated in relation to extubation outcomes	48 hour
Negative Inspiratory Force (NIF)	NIF, a measure of maximal inspiratory muscle strength reflecting the patient's ability to generate negative pressure, will be obtained prior to planned extubation and evaluated in relation to extubation outcomes	48 hour
Rapid Shallow Breathing Index (RSBI)	RSBI, an established index that incorporates respiratory rate and tidal volume to characterize rapid and shallow breathing, will be recorded prior to planned extubation and evaluated in relation to extubation outcomes	48 hour
Mechanical Power to Negative Inspiratory Force Ratio (MP/NIF Ratio)	The MP/NIF ratio, reflecting the relationship between ventilatory mechanical load and inspiratory muscle capacity, will be calculated prior to planned extubation and evaluated in relation to extubation outcomes	48 hour

Collaborators and Investigators

• Sponsor: Anıl Berkay Balıtatlı

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): April 7, 2026
• Study Completion (Actual): April 7, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical power; Airway occlusion pressure; Weaning mechanical ventilation; Negative inspiratory
• Other Study ID Numbers: Mechanical Power

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No