Mechanical Ventilation, Respiratory Failure
Conditions
Keywords
Esophageal manometry, Respiratory monitoring, Mechanical ventilation, Pleural pressure
Brief summary
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
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.
Interventions
DEVICEintelligent Esophageal Pressure Catheter (iEPC)
Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry. Comparator: Esophageal balloon catheter (NutriVent).
Sponsors
Pulmotech B.V.
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Method comparison study; participants serve as their own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter. | 30 minutes | Absolute Pes value (in cmH2O) at end-expiration and at peak inspiration (based on flow recordings) will be recorded. |
| Difference in relative Pes-derived parameters obtained by solid state catheter vs. balloon catheter. | 30 minutes | Relative Pes value (cmH2O) will be measured as the inspiratory amplitude in Pes. |
Countries
Netherlands
Outcome results
None listed