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| Name | Class |
|---|---|
| Pulmotech B.V. | UNKNOWN |
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Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid-state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.
This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.
Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.
This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.
Subjects will receive a standard balloon esophageal catheter and a solid-state pressure catheter for simultaneous measurements of Pes. Study population will be post-surgical ICU patients. Measurements will be performed during clinical mechanical ventilation settings which include a first phase of passive controlled ventilation (patient is still sedated after surgery) as well a phase of partially-assisted ventilation where the patient's breathing effort has resumed and is assisted by the ventilator. During both phases, 10-15 minutes of tidal breathing will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal manometry using a solid state sensor vs. balloon catheter | Experimental | Placement of both a solid state and balloon esophageal pressure (Pes) catheter. Pes recordings of these catheters will be acquired simultaneously during both controlled mechanical ventilation and assisted mechanical ventilation, for 10-15 minutes per phase. Ventilator settings/protocol will be as per standard-of-care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intelligent Esophageal Pressure Catheter (iEPC) | Device | Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry. Comparator: Esophageal balloon catheter (NutriVent). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter. | Absolute Pes value (in cmH2O) at end-expiration and at peak inspiration (based on flow recordings) will be recorded. | 30 minutes |
| Difference in relative Pes-derived parameters obtained by solid state catheter vs. balloon catheter. | Relative Pes value (cmH2O) will be measured as the inspiratory amplitude in Pes. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annemijn Jonkman, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39871347 | Derived | van Oosten JP, Goedendorp N, Mousa A, Flink RC, Schaart R, Flinsenberg M, Somhorst P, Gommers DAMPJ, Heunks L, Jonkman AH. Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study. Crit Care. 2025 Jan 27;29(1):47. doi: 10.1186/s13054-025-05279-w. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Method comparison study; participants serve as their own control
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