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Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06051292
Acronym
DECFVTTPM
Enrollment
27
Registered
2023-09-22
Start date
2023-09-18
Completion date
2025-12-30
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome

Keywords

Acute respiratory failure (ARF), esophageal catheter, transpulmonary pressure

Brief summary

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

Interventions

OTHERFast method

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

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

Sponsors

Dr. Behcet Uz Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Optimal catheter filling volumeup 1 hour after catheter placementThe clinician will determine the optimal filling volume of the catheter using two distinct methods

Secondary

MeasureTime frameDescription
Transpulmonary driving pressureup 1 hour after catheter placementThe measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter
Timeup 1 hour after catheter placementThe duration necessary to ascertain the optimal filling volume of the esophageal catheter

Countries

Turkey (Türkiye)

Contacts

Primary ContactHasan Agin, Professor
hasanagin@gmail.com05362013162
Backup ContactGokhan Ceylan, Associate Professor
drgokhanceylan@gmail.com0794542397

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026