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

NCT ID: NCT05817968

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-03-21

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.

Conditions

Respiratory Failure; Mechanical Ventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Esophageal manometry using a solid state sensor vs. balloon catheter

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.

Group Type: EXPERIMENTAL

intelligent Esophageal Pressure Catheter (iEPC)

Intervention Type: DEVICE

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

Comparator: Esophageal balloon catheter (NutriVent).

Interventions

intelligent Esophageal Pressure Catheter (iEPC)

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

Comparator: Esophageal balloon catheter (NutriVent).

Intervention Type: DEVICE

Other Intervention Names

Solid state esophageal pressure catheter, PulmoTech B.V.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmotech B.V.

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Annemijn Jonkman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annemijn Jonkman, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 39871347 (View on PubMed)

Other Identifiers

MEC-2023-0119

Identifier Type: -

Identifier Source: org_study_id