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

NCT05817968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-05-02

No results posted yet for this study

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

Interventions

DEVICE

intelligent Esophageal Pressure Catheter (iEPC)

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

Sponsors & Collaborators

Principal Investigators

  • Annemijn Jonkman, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2024-03-21
Completion
2024-03-21

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817968 on ClinicalTrials.gov