Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement (DECFVTTPM)

Dr. Behcet Uz Children's Hospital

Status: Enrolling

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

Treatments: Other: Fast method; Other: Conventional method

Study type: Interventional

Funder types: Other

Identifiers

NCT06051292

02020395

Details and patient eligibility

About

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

Enrollment: 27 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Fast decremental

Experimental group

Description:

fast decremental catheter volume titration will be applied

Treatment:

Other: Fast method

Conventional

Active Comparator group

Description:

conventional catheter volume titration will be applied

Treatment:

Other: Conventional method