Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Comparison of a Solid State Versus Balloon Esophageal Catheter for Estimation of Pleural Pressure in Surgical ICU Patients

Conditions
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Mechanical Ventilation, Respiratory Failure

Intervention / Treatment
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* Device: intelligent Esophageal Pressure Catheter (iEPC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Patient requiring mechanical ventilation at the ICU following cardiothoracic or abdominal surgery Age ≥ 18 year Exclusion Criteria: Pregnancy Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia) Nasal bleeding within the last <2 weeks Presence of pneumothorax Use of anticoagulants that increase the risk of catheter insertion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Method comparison study; participants serve as their own control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophageal manometry using a solid state sensor vs. balloon catheter<br>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)<br>* Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry. Comparator: Esophageal balloon catheter (NutriVent).<br>* Other names: Solid state esophageal pressure catheter, PulmoTech B.V.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal manometry, Respiratory monitoring, Mechanical ventilation, Pleural pressure