Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06051292

Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes).

However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters.

To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes

Recruiting

Interested in participating?

Request Info

Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydin Obstetric and pediatrics Hospital, Aydin, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients between 1 months and 18 years
  • Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours
  • Informed consent was signed by next of kin
  • Requiring esophageal catheter application

Exclusion criteria

  • Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours
  • Patient included in another interventional study in the last 30 days
  • Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies
  • Patient included in another interventional research study under consent
  • Patient already enrolled in the present study in a previous episode of acute respiratory failure

Treatment and study plan

Fast method

Other

Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements

Conventional method

Other

Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements

Primary outcomes

  1. Optimal catheter filling volume

    Time frame: up 1 hour after catheter placement

    The clinician will determine the optimal filling volume of the catheter using two distinct methods

Secondary outcomes

  1. Transpulmonary driving pressure

    Time frame: up 1 hour after catheter placement

    The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter

  2. Time

    Time frame: up 1 hour after catheter placement

    The duration necessary to ascertain the optimal filling volume of the esophageal catheter

Study contacts

Contact information is provided by the study sponsor or research team.

Gokhan Ceylan, Associate Professor

CONTACT

[email protected]

0794542397

Hasan Agin, Professor

CONTACT

[email protected]

05362013162

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Registry information

Official study title

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Acronym: DECFVTTPM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Mar 20, 2025

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.

Published trials that share one or more normalized conditions with this study.