An interventional study of intelligent Esophageal Pressure Catheter (iEPC) in Respiratory Failure and Mechanical Ventilation, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Other
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 16 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
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.
Device: intelligent Esophageal Pressure Catheter (iEPC)
Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry. Comparator: Esophageal balloon catheter (NutriVent).
Also known as: Solid state esophageal pressure catheter, PulmoTech B.V.
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.
Time frame: 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.
Time frame: 30 minutes
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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