Comparing Formulations of Mechanical Power Using Geometric Methods

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06413472
• Other study ID #: 2024-37
• Status: Active, not recruiting
• Start date: January 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Basaksehir Çam & Sakura City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ventilator-Induced Lung Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Basaksehir Cam Sakura City Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Basaksehir Çam & Sakura City Hospital	SBÜ Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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- — View Citation

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. — View Citation

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. — View Citation

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: 10.2373 — View Citation

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. — View Citation

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. — View Citation

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: — View Citation

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. do — View Citation

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 ventilati — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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