Comparison of a Solid State Versus Balloon Esophageal Catheter for Estimation of Pleural Pressure in Surgical ICU Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure
- Sponsor
- Erasmus Medical Center
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Annemijn Jonkman
Assistant Professor
Erasmus Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter.
Time Frame: 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.
Time Frame: 30 minutes
Relative Pes value (cmH2O) will be measured as the inspiratory amplitude in Pes.