Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure
- Conditions
- Respiratory FailureMechanical Ventilation
- Interventions
- Device: intelligent Esophageal Pressure Catheter (iEPC)
- Registration Number
- NCT05817968
- Lead Sponsor
- Erasmus Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Signed informed consent
- Patient requiring mechanical ventilation at the ICU following cardiothoracic or abdominal surgery
- Age ≥ 18 year
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Esophageal manometry using a solid state sensor vs. balloon catheter intelligent Esophageal Pressure Catheter (iEPC) 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Erasmus MC
🇳🇱Rotterdam, Zuid-Holland, Netherlands