Clinical trial NCT05817968: Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure
Official title: Comparison of a Solid State Versus Balloon Esophageal Catheter for Estimation of Pleural Pressure in Surgical ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Mechanical Ventilation
Keywords: Esophageal manometry
Respiratory monitoring
Mechanical ventilation
Pleural pressure
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Pulmotech B.V.
First posted: 2023-04-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Method comparison study; participants serve as their own control
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter.
timeFrame: 30 minutes
measure: Difference in relative Pes-derived parameters obtained by solid state catheter vs. balloon catheter.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Annemijn Jonkman, PhD
role: PRINCIPAL_INVESTIGATOR
References: