Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fast method, Conventional method.
- Who it may be relevant to
- Registry conditions: Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome. Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement
Overview
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
Interventions
- Other Fast method
Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements - Other Conventional method
Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
Primary outcome measures
- Optimal catheter filling volume [Time frame: up 1 hour after catheter placement]
Secondary outcome measures (2)
- Transpulmonary driving pressure [Time frame: up 1 hour after catheter placement]
- Time [Time frame: up 1 hour after catheter placement]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 4 centers
- Aydin Obstetric and pediatrics Hospital — Aydin
- Erzurum Regional Research and Training Hospital — Erzurum
- Cam Sakura Research and Training Hospital — Istanbul
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Trai — Izmir
Publications
- 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. PMID 25634481
- 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. PMID 29089460
- 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. PMID 27063290
Identifiers
NCT: NCT06051292 · 02020395