NCT07099729

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 25, 2025

Last Update Submit

July 25, 2025

Conditions

Keywords

mechanical powervolume control ventilationpressure control ventilation

Outcome Measures

Primary Outcomes (1)

  • Agreement Between Dynamic Mechanical Power (MPdyn) and Geometric Mechanical Power (MPgeo) Across Ventilation Modes and I:E Ratios

    To assess the agreement between MPdyn (calculated using the dynamic mechanical power formula) and MPgeo (calculated from ventilator screenshots) in patients with ARDS under four different ventilation settings: VCV with I:E 1:2 VCV with I:E 1:1 PCV with I:E 1:2 PCV with I:E 1:1 Agreement will be quantified using Bland-Altman analysis and correlation coefficients.

    Between 24 and 48 hours after ICU admission

Study Arms (1)

ARDS patients group

This group includes all patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) who underwent both volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes in a sequential and crossover manner.

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

Interventions

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.

ARDS patients group

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.

ARDS patients group

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.

ARDS patients group

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.

ARDS patients group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult ICU patients diagnosed with ARDS and receiving mechanical ventilation (VCV or PCV mode) at a tertiary care hospital. Data will be collected between 24 and 48 hours after ICU admission.

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of moderate-to-severe ARDS according to the Berlin criteria
  • Receiving mechanical ventilation in volume-controlled (VCV) or pressure-controlled (PCV) mode
  • Stable hemodynamics during data collection
  • Expected to remain under mechanical ventilation for at least 48 hours
  • Written informed consent from legal representative

You may not qualify if:

  • Presence of chest tube or pneumothorax
  • Known neuromuscular disease affecting respiratory function
  • Pregnancy
  • Patients with do-not-resuscitate (DNR) or limitation-of-therapy orders
  • Incomplete ventilator data or poor-quality screenshots

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Sadi Konuk Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

  • Marini JJ, Rodriguez RM, Lamb V. Bedside estimation of the inspiratory work of breathing during mechanical ventilation. Chest. 1986 Jan;89(1):56-63. doi: 10.1378/chest.89.1.56.

    PMID: 3940790BACKGROUND
  • Cabello B, Mancebo J. Work of breathing. Intensive Care Med. 2006 Sep;32(9):1311-4. doi: 10.1007/s00134-006-0278-3. Epub 2006 Jul 13. No abstract available.

    PMID: 16838150BACKGROUND
  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

    PMID: 22797452BACKGROUND
  • Acicbe O, Ozgur CY, Rahimi P, Canan E, Asar S, Cukurova Z. The effect of inspiratory rise time on mechanical power calculations in pressure control ventilation: dynamic approach. Intensive Care Med Exp. 2023 Dec 20;11(1):98. doi: 10.1186/s40635-023-00584-6.

    PMID: 38117345BACKGROUND
  • Iotti GA, Braschi A, Brunner JX, Smits T, Olivei M, Palo A, Veronesi R. Respiratory mechanics by least squares fitting in mechanically ventilated patients: applications during paralysis and during pressure support ventilation. Intensive Care Med. 1995 May;21(5):406-13. doi: 10.1007/BF01707409.

    PMID: 7665750BACKGROUND
  • Asar S, Acicbe O, Sabaz MS, Kucur Tulubas E, Hergunsel GO, Cukurova Z, Canan E, Cakar N. Simplified calculation of mechanical power for pressure controlled ventilation in Covid-19 ARDS patients. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):42-50. doi: 10.23736/S0375-9393.21.15741-4.

    PMID: 35224956BACKGROUND
  • van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.

    PMID: 31359082BACKGROUND
  • Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.

    PMID: 31101961BACKGROUND
  • Chi Y, He H, Long Y. A simple method of mechanical power calculation: using mean airway pressure to replace plateau pressure. J Clin Monit Comput. 2021 Oct;35(5):1139-1147. doi: 10.1007/s10877-020-00575-y. Epub 2020 Aug 11.

    PMID: 32780353BACKGROUND
  • Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.

    PMID: 31773328BACKGROUND
  • Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.

    PMID: 31931417BACKGROUND
  • Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.

    PMID: 30291378BACKGROUND
  • Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

    PMID: 27620287BACKGROUND
  • Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.

    PMID: 35644896BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 1, 2025

Study Start

April 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared due to institutional restrictions and ethical considerations concerning patient confidentiality.

Locations