What type of study is this?

This is a RCT study (also classified as: Pre-Registered Trial).

August 16, 2025Open Access

Protective mechanical ventilation controlled by the real-time mechanical energy measurement

Key Points

No significant difference in mechanical energy outcomes between real-time monitored and concealed groups was found, indicating limited effectiveness.
A total of 33 adults were randomized in the trial, showing a strong correlation between night-time mechanical energy levels and lung injury risk.
Randomized controlled trial assessed mechanical ventilation effectiveness with real-time monitoring of mechanical energy parameters for acute respiratory failure management.
Observations during night shifts highlighted risks of elevated mechanical energy, emphasizing the need for careful monitoring during higher-risk periods.

Abstract

Abstract Background Despite the substantial advancements in mechanical ventilation (MV), mortality remains high. Mechanical energy (ME), MV forces are associated with outcomes. Real-time monitoring of ME and the adjustment of MV according to ME may result in ventilation with lower ME. Methods Randomized controled trial conducted at the ECMO Centre Ostrava, Czech Republic, from March 2023 to March 2024 enrolled adult patients on MV (with or without extracorporeal membrane oxygenation, ECMO) with acute respiratory failure. A system for real-time ME monitoring (geometric method and simplified Becher´s formula) has been developed. In the intervention arm, the physician was able to observe the ME in real time and adjust the MV parameters accordingly. In the control group, the ME was concealed. Results A total of 494 subjects were screened and 33 patients were randomized (further 7 ECMO patients). There was no significant difference between the control and intervention groups. Median MEGeom was 3.22 J/min (maximum 15.2 J/min) and MEBecher of 5.94 J/min (maximum 18.4 J/min). Only a weak (but significant, p = 0.0001) correlation between MEGeom and MEBecher was observed. A highly significant difference was observed in ME between day and night (6 a.m. − 6 p.m.). Conclusion Although real-time ME measurement is feasible, there was no significant difference in ME between the control and intervention groups with low ME in both groups. Experience physicians was capable of safe MV, even if they do not know the exact ME value. The night shift was a high-risk period for developing lung damage due to elevated ME. Trial registration ClinicalTrials NCT06035146

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