NCT06051292 Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
| NCT ID | NCT06051292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Behcet Uz Children's Hospital |
| Condition | Pediatric Acute Respiratory Distress Syndrome (PARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27 participants in total. It began in 2023-09-18 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Hasan Agin, Professor
STUDY DIRECTOR
Behcet Uz Children's Hospital
Frequently Asked Questions
Who can join the NCT06051292 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Pediatric Acute Respiratory Distress Syndrome (PARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06051292 currently recruiting?
Yes, NCT06051292 is actively recruiting participants. Contact the research team at hasanagin@gmail.com for enrollment information.
Where is the NCT06051292 trial being conducted?
This trial is being conducted at Aydin, Turkey (Türkiye), Erzurum, Turkey (Türkiye), Istanbul, Turkey (Türkiye), Izmir, Turkey (Türkiye).
Who is sponsoring the NCT06051292 clinical trial?
NCT06051292 is sponsored by Dr. Behcet Uz Children's Hospital. The principal investigator is Hasan Agin, Professor at Behcet Uz Children's Hospital. The trial plans to enroll 27 participants.