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Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Study acronym: DECFVTTPM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 20, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Nov 30, 2024 to Nov 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 30, 2023 to Nov 30, 2024
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    • Site details revised at 4 of 4 sites
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06051292
Lead Sponsor Dr. Behcet Uz Children's Hospital
Conditions
(from sponsor)
Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome
Related terms Respiratory Distress Syndrome
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov