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Clinical Trials/NCT06051292
NCT06051292
Recruiting
Not Applicable

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Dr. Behcet Uz Children's Hospital4 sites in 1 country27 target enrollmentSeptember 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Acute Respiratory Distress Syndrome (PARDS)
Sponsor
Dr. Behcet Uz Children's Hospital
Enrollment
27
Locations
4
Primary Endpoint
Optimal catheter filling volume
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
September 18, 2023
End Date
December 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Dr. Behcet Uz Children's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hasan ağın

Professor

Dr. Behcet Uz Children's Hospital

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

Outcomes

Primary Outcomes

Optimal catheter filling volume

Time Frame: up 1 hour after catheter placement

The clinician will determine the optimal filling volume of the catheter using two distinct methods

Secondary Outcomes

  • Transpulmonary driving pressure(up 1 hour after catheter placement)
  • Time(up 1 hour after catheter placement)

Study Sites (4)

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