Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Study Overview
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Brief Summary
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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

Official Title
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Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

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

Intervention / Treatment
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* Other: Fast method
* Other: Conventional method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast decremental<br>fast decremental catheter volume titration will be applied | Other: Fast method<br>* Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements<br>|
| Active Comparator: Conventional<br>conventional catheter volume titration will be applied | Other: Conventional method<br>* Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal catheter filling volume | The clinician will determine the optimal filling volume of the catheter using two distinct methods | up 1 hour after catheter placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transpulmonary driving pressure | The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter | up 1 hour after catheter placement | 
| Time | The duration necessary to ascertain the optimal filling volume of the esophageal catheter | up 1 hour after catheter placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory failure (ARF), esophageal catheter, transpulmonary pressure