Acute Respiratory Distress Syndrome (ARDS)NCT07099729
Comparison of Dynamic Mechanical Power Formula With Geometric Method in Pressure- and Volume-Controlled Ventilation: A Validation Study
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Ventilated Patient in Intensive Care, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Ventilated Patient in Intensive Care
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Sadi Konuk Research Hospital
Istanbul
About this study
Official title: Comparison of the Dynamic Mechanical Power Formula With the Geometric Method in Volume-Controlled and Pressure-Controlled Ventilation Modes in Patients With Acute Respiratory Distress Syndrome: A Prospective Validation Study
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.
Read more
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.
Read the detailed description
Mechanical power (MP) is an integrative parameter that quantifies the energy delivered to the lungs during mechanical ventilation. It accounts for multiple factors contributing to ventilator-induced lung injury (VILI), including tidal volume, airway pressures, respiratory rate, compliance, and resistance. MP has been shown to correlate strongly with morbidity and mortality in critically ill patients, particularly those with acute respiratory distress syndrome (ARDS).
Several MP calculation formulas have been proposed for volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). While formulas such as MPrs (Gattinoni) and MPLM (Trinkle) are widely used, many of them require precise measurement of inspiratory resistance (Raw), which is often not readily accessible at the bedside-especially in PCV. To address this, a dynamic mechanical power formula (MPdyn) was developed by Asar et al., which estimates MP without the need for inspiratory resistance. MPdyn has demonstrated good agreement with MPrs in VCV and with MPLM in PCV. However, it has not been directly validated against the geometric method, which remains the gold standard for MP calculation.
The geometric method involves calculating the area enclosed by the pressure-volume (P-V) loop on the ventilator screen. This area represents the energy per breath, which can be multiplied by respiratory rate to yield MP. Modern ventilators, such as the Maquet Servo-U, provide high-resolution graphical displays that allow for precise area calculations using digital image processing.
This prospective observational study was conducted in the intensive care unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital, Istanbul. A total of 37 ARDS patients who were deeply sedated and under controlled mechanical ventilation were enrolled. Each patient was ventilated in both VCV and PCV modes with two different I:E ratios (1:2 and 1:1). For each setting, three screenshots of the P-V loop were captured, resulting in 12 images per patient and 444 images in total.
Geometric mechanical power (MPgeo) was calculated using Python-based image analysis (OpenCV, NumPy, and PIL libraries). The region of interest (ROI) corresponding to the P-V loop was extracted, binarized, and segmented to compute the loop area. This pixel-based area was then scaled using the known tidal volume (TVe) and pressure (Pinsp) values to obtain mechanical energy per breath. MPgeo was calculated as:
MPgeo (J/min) = [E_breath × RR] + [PEEP × TVe × RR × 0.098]
Dynamic mechanical power (MPdyn) was calculated using the following formula:
MPdyn = MVe × [WOBv + (PEEP × 0.098)] where MVe is the expiratory minute volume (L/min), WOBv is the work of breathing per liter (J/L), and PEEP is the end-expiratory pressure (cmH₂O).
Statistical analysis included descriptive statistics, Shapiro-Wilk test for normality, univariable linear regression to assess correlation between MPdyn and MPgeo, and Bland-Altman analysis to evaluate agreement between methods. Paired measurements were analyzed both at the patient-averaged level and for all individual data points.
The primary outcome of the study was the degree of agreement between MPdyn and MPgeo under different ventilator modes (VCV, PCV) and I:E ratios (1:1, 1:2). Secondary analyses included evaluating potential biases and limits of agreement.
This study is expected to validate MPdyn as a reliable, practical alternative to geometric calculations in clinical settings, facilitating routine bedside monitoring of mechanical power without requiring complex measurements or advanced equipment.
- Being tested
- Volume-Controlled Ventilation (VCV) with inspiratory-to-expiratory (I:E) ratio of 1:2., Volume-Controlled Ventilation (VCV) with inspiratory-to-expiratory (I:E) ratio of 1:1., Pressure-Controlled Ventilation (PCV) with inspiratory-to-expiratory (I:E) ratio of 1:2., Pressure-Controlled Ventilation (PCV) with inspiratory-to-expiratory (I:E) ratio of 1:1.
- Keywords
- mechanical power, volume control ventilation, pressure control ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-Controlled Ventilation (VCV) with inspiratory-to-expiratory (I:E) ratio of 1:2.Other
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.
Volume-Controlled Ventilation (VCV) with inspiratory-to-expiratory (I:E) ratio of 1:1.Other
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.
Pressure-Controlled Ventilation (PCV) with inspiratory-to-expiratory (I:E) ratio of 1:2.Other
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.
Pressure-Controlled Ventilation (PCV) with inspiratory-to-expiratory (I:E) ratio of 1:1.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 24 and 48 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Furkan Tontu, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099729
- Sponsor's protocol ID
- 2025-76
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to institutional restrictions and ethical considerations concerning patient confidentiality.
Publications
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.
PubMed 3940790Cabello 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.
PubMed 16838150ARDS 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.
PubMed 22797452Acicbe 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.
PubMed 38117345Iotti 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.
PubMed 7665750Asar 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.
PubMed 35224956van 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.
PubMed 31359082Becher 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.
PubMed 31101961Chi 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.
PubMed 32780353Giosa 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.
PubMed 31773328Asar 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.
PubMed 31931417Serpa 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.
PubMed 30291378Gattinoni 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.
PubMed 27620287Trinkle 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.
PubMed 35644896
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Dynamic Mechanical Power Formula With the Geometric Method in Volume-Controlled and Pressure-Controlled Ventilation Modes in Patients With Acute Respiratory Distress Syndrome: A Prospective Validation Study
- ClinicalTrials.gov ID
- NCT07099729
- Acronym / sponsor ID
- 2025-76
- Keywords
- mechanical power, volume control ventilation, pressure control ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mechanical power (MP) is an integrative parameter that quantifies the energy delivered to the lungs during mechanical ventilation. It accounts for multiple factors contributing to ventilator-induced lung injury (VILI), including tidal volume, airway pressures, respiratory rate, compliance, and resistance. MP has been shown to correlate strongly with morbidity and mortality in critically ill patients, particularly those with acute respiratory distress syndrome (ARDS).
Several MP calculation formulas have been proposed for volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). While formulas such as MPrs (Gattinoni) and MPLM (Trinkle) are widely used, many of them require precise measurement of inspiratory resistance (Raw), which is often not readily accessible at the bedside-especially in PCV. To address this, a dynamic mechanical power formula (MPdyn) was developed by Asar et al., which estimates MP without the need for inspiratory resistance. MPdyn has demonstrated good agreement with MPrs in VCV and with MPLM in PCV. However, it has not been directly validated against the geometric method, which remains the gold standard for MP calculation.
The geometric method involves calculating the area enclosed by the pressure-volume (P-V) loop on the ventilator screen. This area represents the energy per breath, which can be multiplied by respiratory rate to yield MP. Modern ventilators, such as the Maquet Servo-U, provide high-resolution graphical displays that allow for precise area calculations using digital image processing.
This prospective observational study was conducted in the intensive care unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital, Istanbul. A total of 37 ARDS patients who were deeply sedated and under controlled mechanical ventilation were enrolled. Each patient was ventilated in both VCV and PCV modes with two different I:E ratios (1:2 and 1:1). For each setting, three screenshots of the P-V loop were captured, resulting in 12 images per patient and 444 images in total.
Geometric mechanical power (MPgeo) was calculated using Python-based image analysis (OpenCV, NumPy, and PIL libraries). The region of interest (ROI) corresponding to the P-V loop was extracted, binarized, and segmented to compute the loop area. This pixel-based area was then scaled using the known tidal volume (TVe) and pressure (Pinsp) values to obtain mechanical energy per breath. MPgeo was calculated as:
MPgeo (J/min) = [E_breath × RR] + [PEEP × TVe × RR × 0.098]
Dynamic mechanical power (MPdyn) was calculated using the following formula:
MPdyn = MVe × [WOBv + (PEEP × 0.098)] where MVe is the expiratory minute volume (L/min), WOBv is the work of breathing per liter (J/L), and PEEP is the end-expiratory pressure (cmH₂O).
Statistical analysis included descriptive statistics, Shapiro-Wilk test for normality, univariable linear regression to assess correlation between MPdyn and MPgeo, and Bland-Altman analysis to evaluate agreement between methods. Paired measurements were analyzed both at the patient-averaged level and for all individual data points.
The primary outcome of the study was the degree of agreement between MPdyn and MPgeo under different ventilator modes (VCV, PCV) and I:E ratios (1:1, 1:2). Secondary analyses included evaluating potential biases and limits of agreement.
This study is expected to validate MPdyn as a reliable, practical alternative to geometric calculations in clinical settings, facilitating routine bedside monitoring of mechanical power without requiring complex measurements or advanced equipment.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS patients group | – | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ARDS patients group |
| 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 | ARDS patients group |
| 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 | ARDS patients group |
| 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. | Other | ARDS patients group |
Primary outcome
Agreement Between Dynamic Mechanical Power (MPdyn) and Geometric Mechanical Power (MPgeo) Across Ventilation Modes and I:E Ratios
Time frame: Between 24 and 48 hours after ICU admission
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 3940790Marini 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.
- Background: PubMed 16838150Cabello 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.
- Background: PubMed 22797452ARDS 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.
- Background: PubMed 38117345Acicbe 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.
- Background: PubMed 7665750Iotti 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.
- Background: PubMed 35224956Asar 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.
- Background: PubMed 31359082van 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.
- Background: PubMed 31101961Becher 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.
- Background: PubMed 32780353Chi 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.
- Background: PubMed 31773328Giosa 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.
- Background: PubMed 31931417Asar 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.
- Background: PubMed 30291378Serpa 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.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to institutional restrictions and ethical considerations concerning patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Ventilated Patient in Intensive Care, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Dynamic Mechanical Power (MPdyn) and Geometric Mechanical Power (MPgeo) Across Ventilation Modes and I:E Ratios (time frame: Between 24 and 48 hours after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07099729, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.