Comparing Formulations of Mechanical Power Using Geometric Methods

Comparing Formulations of Mechanical Power Using Geometric Methods at Different Inspiratory Rise and Pause Times: A Validation Study

We aimed to compare different formulations of mechanical power using geometric methods at varying inspiratory rise and pause times.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Respiratory Distress Syndrome; Ventilator-Induced Lung Injury
• Intervention / Treatment: Procedure: Mechanical ventilator adjustment for PCV; Procedure: Mechanical ventilator adjustment for VCV

Detailed Description

One of the formulas used to calculate mechanical power (MP) is the dynamic mechanical power formula (MPdyn) developed by Asar et al. This formula, in Volume-Controlled Ventilation (VCV) mode, calculates the same MP values as the comprehensive mechanical power formula (MPrs) from Gattinoni et al., without requiring the inspiratory resistance value. Similarly, in Pressure-Controlled Ventilation (PCV) mode, the MPdyn formula calculates mechanical power values comparable to those from the mechanical power formula (MPlm) proposed by Trinkle et al., also without the need for inspiratory resistance. However, the MPdyn formula has not been compared with the geometric method, considered the gold standard for mechanical power calculation. This limitation has been highlighted as a drawback for clinical use, particularly when applying the formula in both VCV and PCV modes.

In this study, we aim to compare the MPdyn formula with the MPLM and MPrs formulas, against the standard geometric method (MPstd), for mechanical power calculations in ARDS patients during both pressure-controlled and volume-controlled ventilation, at varying inspiratory rise (Tslope) and pause times (Tpause).

• Study Type: Observational
• Enrollment (Estimated): 38

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Basaksehir Cam Sakura City Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

"Patients with a diagnosis of ARDS in the general intensive care unit of the Anesthesiology and Reanimation Clinic at Bakırköy Dr. Sadi Konuk Training and Research Hospital."

Description

Inclusion Criteria:

The study will include ARDS patients who are deeply sedated and ventilated in Pressure-Controlled Ventilation (PCV or PRVC) or Volume-Controlled Ventilation (VCV) modes during the 24-48 hour period of their stay in the intensive care unit.

Exclusion Criteria:

Patients with incomplete data, those with COPD and heart failure, pregnant patients, those with a thoracopleural fistula, and hemodynamically unstable patients will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS patients-PCV; Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV).	Procedure: Mechanical ventilator adjustment for PCV; In Pressure-Controlled Ventilation (PCV) mode, adjustments to the Tslope time will be made at every 5-minute interval, with incremental increases of 5% (ranging from 5 to 20), for each I:E ratio (1:2 and 1:1). After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained (Figure 1). A total of 40 P-V loop screenshots will be captured over a 40-minute period (20 for the 1:2 ratio and 20 for the 1:1 ratio), which will be stored in the ventilator's memory. The stored data will then be transferred from the ventilator's memory to a computer via a flash drive.
ARDS patients-VCV; Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV).	Procedure: Mechanical ventilator adjustment for VCV; In Volume-Controlled Ventilation (VCV) mode, at each I:E ratio (1:2 and 1:1), adjustments to the Tpause duration will be made every 40 minutes, with 10% increases at intervals of 10%, 20%, and 30%; for the Tslope duration, adjustments will be made every 5 minutes with 5% increases at intervals of 5%, 10%, 15%, and 20%. This will result in a total of 120 P-V loop screenshots taken over a 120-minute period (60 for the 1:2 ratio, with 4x5x3=60, and 60 for the 1:1 ratio, also with 4x5x3=60). These screenshots will be stored in the ventilator's memory and subsequently transferred to a computer via a flash drive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPstd	The mechanical power value measured using the geometric method (MPstd).	120 minute
MPdyn	The mechanical power value measured using the dynamic mechanical power formula (MPdyn) developed by Asar et al.	120 minute
MPrs	The mechanical power value measured using Gattinoni et al.'s comprehensive formula (MPrs).	120 minute
MPlm	The mechanical power value measured using the formula developed by Trinkle et al (MPlm).	120 minute

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Collaborators: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 2024-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided.

Drug and device information, study documents

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