Comparison of Dynamic Mechanical Power Formula With Geometric Method in Pressure- and Volume-Controlled Ventilation: A Validation Study

NCT07099729 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2025-08-01

No results posted yet for this study

Summary

This prospective observational study aims to validate the dynamic mechanical power (MPdyn) formula by comparing it with the gold-standard geometric method (MPgeo) in patients with acute respiratory distress syndrome (ARDS) who are mechanically ventilated in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes.

Mechanical power (MP) is a composite parameter that integrates multiple components of ventilator-induced lung injury (VILI) and has shown strong associations with mortality in ARDS. While several formulas exist for calculating MP in VCV and PCV modes, most require inspiratory resistance, which is not readily available at the bedside. The MPdyn formula, introduced by Asar et al., allows for bedside calculation without inspiratory resistance and has shown good agreement with established formulas such as MPrs and MPLM. However, it has never been validated against the geometric method, which calculates mechanical power based on the area of the pressure-volume (P-V) loop and is considered the most accurate standard.

In this single-center study, 37 deeply sedated ARDS patients were ventilated with a Servo-U ventilator using both VCV and PCV modes. For each mode, two different I:E ratios (1:2 and 1:1) were applied, and 12 screenshots of full P-V loops were captured per patient, totaling 444 images. Geometric MP (MPgeo) was calculated using Python-based image processing with OpenCV and NumPy libraries. Dynamic mechanical power (MPdyn) was computed using ventilator-recorded values of minute volume (MVe), work of breathing per liter (WOBv), and PEEP.

The primary outcome was the agreement between MPdyn and MPgeo values under different ventilator modes and I:E ratios. Secondary outcomes included regression correlation (R²) and Bland-Altman analysis of bias and limits of agreement. This study seeks to determine whether MPdyn is a valid and reliable surrogate for geometric mechanical power, particularly in clinical settings where bedside calculation is needed and inspiratory resistance cannot be easily measured.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)
  • Ventilated Patient in Intensive Care

Interventions

OTHER

Volume-Controlled Ventilation (VCV) with inspiratory-to-expiratory (I:E) ratio of 1:2.

Patients received volume-controlled ventilation (VCV) with an inspiratory-to-expiratory (I:E) ratio of 1:2. Mechanical power was calculated geometrically (MPgeo) using ventilator screenshots, and results were compared with dynamic mechanical power (MPdyn) values.

OTHER

Volume-Controlled Ventilation (VCV) with inspiratory-to-expiratory (I:E) ratio of 1:1.

Patients received volume-controlled ventilation (VCV) with an inspiratory-to-expiratory (I:E) ratio of 1:1. MPgeo was computed from ventilator screenshots and compared to MPdyn values to assess agreement.

OTHER

Pressure-Controlled Ventilation (PCV) with inspiratory-to-expiratory (I:E) ratio of 1:2.

Patients received pressure-controlled ventilation (PCV) with an I:E ratio of 1:2. Mechanical power was measured using both geometric (MPgeo) and dynamic (MPdyn) methods for validation purposes.

OTHER

Pressure-Controlled Ventilation (PCV) with inspiratory-to-expiratory (I:E) ratio of 1:1.

Patients received pressure-controlled ventilation (PCV) with an I:E ratio of 1:1. Geometric mechanical power calculations from ventilator screenshots were compared with MPdyn values for accuracy assessment.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099729 on ClinicalTrials.gov