Respiratory failure & ventilation

Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study

Crit CarePublished Diagnostic accuracy study

Authors' conclusion

The novel solid-state pressure transducer showed good accuracy on the bench, in healthy volunteers and in ventilated ICU-patients.

Study context

Population
Bench setup (5 days), spontaneously breathing healthy volunteers and mechanically ventilated ICU patients15 volunteers · 16 ICU patients
Comparison
Solid-state esophageal pressure transducer vs balloon catheter
Outcome
Agreement of Pes measurements (bias and upper and lower limits of agreement, Pessolid - Pesbal); non-inferiority hypothesised
Methodological detailsbench and first-in-human validation, Bland-Altman analysis with mixed effects modelling and bootstrapping
  • Bench and first-in-human validation
  • Bland-Altman analysis with mixed effects modelling and bootstrapping

Performance

As reported in the abstract

Agreement of solid-state Pes (Pessolid) vs balloon catheter Pes (Pesbal): bias (Pessolid - Pesbal) [upper LoA; lower LoA]
Bench: positive bias (Psolid - Pref) for absolute minimal and maximum pressures, cmH2O
around 1
Healthy volunteers, end-expiratory pressure (Pes), cmH2O
1.59 [8.21; - 5.02]
Healthy volunteers, end-inspiratory Pes, cmH2O
- 2.32 [4.27; - 8.92]
Healthy volunteers, ΔPes, cmH2O
3.91 [11.04; - 3.23]
ICU patients, end-expiratory Pes, controlled/assisted ventilation, cmH2O
- 0.15 [1.41; - 1.72]/- 0.19 [5.23; - 5.62]
ICU patients, end-inspiratory Pes, controlled/assisted ventilation, cmH2O
0.32 [3.45; - 2.82]/- 0.54 [4.81; - 5.90]
ICU patients, ΔPes, controlled/assisted ventilation, cmH2O
0.47 [3.90; - 2.96]/0.35 [4.01; - 3.31]
ICU patients: Limits of agreement (LoA) for static measurements on controlled ventilation
≤ 2cmH2O

Original publication

Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study. Crit Care. Published 27 January 2025. doi:10.1186/s13054-025-05279-w

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