Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study
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Background
Advanced respiratory monitoring through the measurement of esophageal pressure (Pes) as a surrogate of pleural pressure helps guiding mechanical ventilation in ICU patients. Pes measurement with an esophageal balloon catheter, the current clinical reference standard, needs complex calibrations and a multitude of factors influence its reliability. Solid-state pressure sensors might be able to overcome these limitations.
Objectives
To evaluate the accuracy of a new solid-state Pes transducer (Pes solid ). We hypothesized that measurements are non-inferior to those obtained with a properly calibrated balloon catheter (Pes bal ).
Methods
Absolute and relative solid-state sensor Pes measurements were compared to a reference pressure in a 5-day bench setup, and to simultaneously placed balloon catheters in 15 spontaneously breathing healthy volunteers and in 16 mechanically ventilated ICU patients. Bland-Altman analysis was performed with nonparametric bootstrapping to estimate bias and upper and lower limits of agreement (LoA).
Results
Bench study: Solid-state pressure transducers had a positive bias (P solid – P ref ) of around 1 cmH 2 O for the absolute minimal and maximum pressures, and no bias for pressure swings. Healthy volunteers: the solid-state transducer revealed a bias (Pes solid –Pes bal ) [upper LoA; lower LoA] of 1.58 [8.19; −5.03], −2.37 [3.96; −8.69] and 3.94 [11.09; −3.20] cmH 2 O for end-expiratory, end-inspiratory and ΔPes values, respectively. ICU patients: the solid-state transducer showed a bias (Pes solid –Pes bal ) [upper LoA; lower LoA] during controlled / assisted ventilation of: −0.15 [1.39; −1.70] / −0.20 [5.02; −5.41], 0.32 [3.35; −2.72] / −0.54 [4.60; −5.68] and 0.47 [3.79; −2.85] / 0.35 [3.88; −3.18] cmH 2 O for end-expiratory, end-inspiratory and ΔPes values, respectively. LoA were <2cmH 2 O for static measurements on controlled ventilation.
Conclusions
The novel solid-state pressure transducer showed good accuracy on the bench, in healthy volunteers and in ventilated ICU-patients. This could contribute to the implementation of Pes as advanced respiratory monitoring technique.
Trial registration
Clinicaltrials.gov identifier: NCT05817968 (patient study). Registered on 18 April 2023.
