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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817968
• Other study ID #: MEC-2023-0119
• Status: Completed
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: March 21, 2024

Study information

• Verified date: May 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• intelligent Esophageal Pressure Catheter (iEPC)
Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry. Comparator: Esophageal balloon catheter (NutriVent).

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Pulmotech B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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