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/25634481Actively Recruiting
Led by Dr. Behcet Uz Children's Hospital · Updated on 2025-03-20
27
Participants Needed
4
Research Sites
4 weeks
Total Duration
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
Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
H
Hasan Agin, Professor
G
Gokhan Ceylan, Associate Professor
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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F Mojoli, D Chiumello, M Pozzi...
https://pubmed.ncbi.nlm.nih.gov/25634481Justin C Hotz, Cary T Sodetani, Jeffrey Van Steenbergen...
https://pubmed.ncbi.nlm.nih.gov/29089460Francesco Mojoli, Giorgio Antonio Iotti, Francesca Torriglia...
https://pubmed.ncbi.nlm.nih.gov/27063290