Actively Recruiting

Phase Not Applicable
Age: 1Month - 18Years
All Genders
ID06051292

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement in Pediatric Respiratory Distress

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

27

Participants Needed

4

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying pediatric patients with acute respiratory distress syndrome and acute respiratory failure who require mechanical ventilation. The study focuses on measuring transpulmonary pressure (PL), which is important for safe and effective ventilation. Since direct measurement of pleural pressure (Ppl) risks tissue damage, esophageal pressure (Pes) is used as a safer surrogate. However, measuring Pes accurately can be challenging due to potential errors from incorrect catheter filling volumes. The trial compares two methods of adjusting the esophageal catheter's filling volume to optimize Pes measurement in children: a faster decremental method and the conventional Mojoli method. Participants will be randomly assigned to receive either the fast decremental volume titration or the conventional titration technique. Both approaches aim to find the optimal catheter volume within one hour after placement. During the study, children on mechanical ventilation will receive esophageal catheter insertion, and clinicians will monitor and measure Pes and transpulmonary driving pressure over the hour after catheter placement. The primary outcome is determining the best catheter filling volume; secondary outcomes include the transpulmonary driving pressure and the time taken for measurement. The study is double-blind and randomized, ensuring careful assessment of each method's accuracy and efficiency.

CONDITIONS

Brief 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 month and 18 years old
  • Require mechanical ventilation support with stable ventilation settings for the next 2 hours
  • Informed consent signed by next of kin
  • Require esophageal catheter insertion
Not Eligible

You will not qualify if you...

  • Eligible for extubation or ventilation setting changes within the next 2 hours
  • Participated in another interventional study within the last 30 days
  • Unable to have esophageal catheter insertion due to congenital or acquired conditions
  • Currently enrolled in another interventional research study
  • Previously enrolled in this study during an earlier episode of acute respiratory failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 hour after catheter placement

Participants undergo esophageal catheter insertion followed by catheter volume titration using either the fast decremental method or the conventional method to determine optimal filling volume.

1 catheter insertion and titration visit (in-person)

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

G

Gokhan Ceylan, Associate Professor

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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Published Research Related To This Trial

Esophageal pressure measurements under different conditions of intrathoracic pressure. An in vitro study of second generation balloon catheters.

F Mojoli, D Chiumello, M Pozzi...

https://pubmed.ncbi.nlm.nih.gov/25634481

Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS.

Justin C Hotz, Cary T Sodetani, Jeffrey Van Steenbergen...

https://pubmed.ncbi.nlm.nih.gov/29089460

In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable.

Francesco Mojoli, Giorgio Antonio Iotti, Francesca Torriglia...

https://pubmed.ncbi.nlm.nih.gov/27063290