Clinical trial NCT06051292: Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
Official title: Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Acute Respiratory Distress Syndrome (PARDS)
Acute Respiratory Failure
Acute Respiratory Distress Syndrome
Keywords: Acute respiratory failure (ARF)
esophageal catheter
transpulmonary pressure
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Optimal catheter filling volume
timeFrame: up 1 hour after catheter placement
Secondary outcomes:
measure: Transpulmonary driving pressure
timeFrame: up 1 hour after catheter placement
measure: Time
timeFrame: up 1 hour after catheter placement
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin Obstetric and pediatrics Hospital
city: Erzurum
country: Turkey
facility: Erzurum Regional Research and Training Hospital
city: Istanbul
country: Turkey
facility: Cam Sakura Research and Training Hospital
city: Izmir
country: Turkey
facility: The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Study officials:
affiliation: Behcet Uz Children's Hospital
name: Hasan Agin, Professor
role: STUDY_DIRECTOR
References:
citation: Mojoli F, Chiumello D, Pozzi M, Algieri I, Bianzina S, Luoni S, Volta CA, Braschi A, Brochard L. Esophageal pressure measurements under different conditions of intrathoracic pressure. An in vitro study of second generation balloon catheters. Minerva Anestesiol. 2015 Aug;81(8):855-64. Epub 2015 Jan 30.
citation: Hotz JC, Sodetani CT, Van Steenbergen J, Khemani RG, Deakers TW, Newth CJ. Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS. Respir Care. 2018 Feb;63(2):177-186. doi: 10.4187/respcare.05685. Epub 2017 Oct 31.
citation: Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.