Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Not Applicable

Recruiting

• Conditions: Pediatric Acute Respiratory Distress Syndrome (PARDS); Acute Respiratory Failure; Acute Respiratory Distress Syndrome

• Registration Number: NCT06051292
• Lead Sponsor: Dr. Behcet Uz Children's Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-14
• Study Start: 2023-09-18
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Optimal catheter filling volume	up 1 hour after catheter placement	The clinician will determine the optimal filling volume of the catheter using two distinct methods

Secondary Outcome Measures

Name	Time	Method
Time	up 1 hour after catheter placement	The duration necessary to ascertain the optimal filling volume of the esophageal catheter
Transpulmonary driving pressure	up 1 hour after catheter placement	The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter

Trial Locations

Locations (4)

Aydin Obstetric and pediatrics Hospital; 🇹🇷 Aydın, Turkey

Erzurum Regional Research and Training Hospital; 🇹🇷 Erzurum, Turkey

Cam Sakura Research and Training Hospital; 🇹🇷 Istanbul, Turkey

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital; 🇹🇷 Izmir, Turkey