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

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

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

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure; Pediatric Acute Respiratory Distress Syndrome (PARDS)
• Intervention / Treatment: Other: Fast method; Other: Conventional method

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hasan Agin, Professor; Phone Number: 05362013162; Email: hasanagin@gmail.com
• Study Contact Backup: Name: Gokhan Ceylan, Associate Professor; Phone Number: 0794542397; Email: drgokhanceylan@gmail.com

Study Locations

• Turkey
  • Aydın, Turkey, 09020
    • Recruiting
    • Aydin Obstetric and pediatrics Hospital
    • Contact: ekin soydan; Phone Number: +905321003949; Email: dr-ekinsoydan@hotmail.com
  • Erzurum, Turkey, 25180
    • Recruiting
    • Erzurum Regional Research and Training Hospital
    • Contact: Pinar Hepduman, MD; Phone Number: +905531501115; Email: pnrhpdmn@gmail.com
  • Istanbul, Turkey, 34001
    • Recruiting
    • Cam Sakura Research and Training Hospital
    • Contact: Mustafa Colak, MD; Phone Number: +905554180903; Email: colakk@hotmail.com
  • Izmir, Turkey, 35200
    • Recruiting
    • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
    • Contact: Ozlem Sandal, MD; Phone Number: +905067644688; Email: drozlemsarac@hotmail.com
    • Sub-Investigator: Ozlem Sandal
    • Principal Investigator: Gulhan Atakul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Behcet Uz Children's Hospital
• Investigators: Study Director: Hasan Agin, Professor, Behcet Uz Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: transpulmonary pressure; Acute respiratory failure (ARF); esophageal catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
• Other Study ID Numbers: 02020395

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No