Actively Recruiting

Phase Not Applicable
Age: 1Month - 18Years
All Genders
NCT06051292

Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Led by Dr. Behcet Uz Children's Hospital · Updated on 2025-03-20

27

Participants Needed

4

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Aydin Obstetric and pediatrics Hospital

Aydin, Turkey (Türkiye), 09020

Actively Recruiting

2

Erzurum Regional Research and Training Hospital

Erzurum, Turkey (Türkiye), 25180

Actively Recruiting

3

Cam Sakura Research and Training Hospital

Istanbul, Turkey (Türkiye), 34001

Actively Recruiting

4

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, Turkey (Türkiye), 35200

Actively Recruiting

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Research Team

H

Hasan Agin, Professor

CONTACT

G

Gokhan Ceylan, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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