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

NCT05817968 | Completed

• 1 other identifier: MEC-2023-0119
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Mechanical Ventilation

Keywords

Esophageal manometry; Respiratory monitoring; Mechanical ventilation; Pleural pressure

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Esophageal manometry using a solid state sensor vs. balloon catheter

EXPERIMENTAL

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.

Device: intelligent Esophageal Pressure Catheter (iEPC)

Interventions

intelligent Esophageal Pressure Catheter (iEPC) DEVICE

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

Also known as: Solid state esophageal pressure catheter, PulmoTech B.V.

Esophageal manometry using a solid state sensor vs. balloon catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Patient requiring mechanical ventilation at the ICU following cardiothoracic or abdominal surgery
• Age ≥ 18 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Pulmotech B.V.: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (1)

• van Oosten JP, Goedendorp N, Mousa A, Flink RC, Schaart R, Flinsenberg M, Somhorst P, Gommers DAMPJ, Heunks L, Jonkman AH. Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study. Crit Care. 2025 Jan 27;29(1):47. doi: 10.1186/s13054-025-05279-w.

  PMID: 39871347 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Annemijn Jonkman, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Method comparison study; participants serve as their own control

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: October 20, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)