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OpenTrials
Completed

NCT Number: NCT05817968

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intelligent Esophageal Pressure Catheter (iEPC)

Device

Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry.

Comparator: Esophageal balloon catheter (NutriVent).

Other names: Solid state esophageal pressure catheter, PulmoTech B.V.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Pulmotech B.V.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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