Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

NCT06051292 | Recruiting DMC

• 1 other identifier: 02020395
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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

Conditions

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

Keywords

Acute respiratory failure (ARF); esophageal catheter; transpulmonary pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Transpulmonary driving pressure

  up 1 hour after catheter placement

• Time

  up 1 hour after catheter placement

Study Arms (2)

Fast decremental

EXPERIMENTAL

fast decremental catheter volume titration will be applied

Other: Fast method

Conventional

ACTIVE COMPARATOR

conventional catheter volume titration will be applied

Other: Conventional method

Interventions

Fast method OTHER

Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements

Fast decremental

Conventional method OTHER

Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements

Conventional

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (4)

Aydin Obstetric and pediatrics Hospital

Aydin, 09020, Turkey (Türkiye)

RECRUITING

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

RECRUITING

Cam Sakura Research and Training Hospital

Istanbul, 34001, Turkey (Türkiye)

RECRUITING

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, 35200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Hasan Agin, Professor

  Behcet Uz Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Hasan Agin, Professor

CONTACT

05362013162; hasanagin@gmail.com

Gokhan Ceylan, Associate Professor

CONTACT

0794542397; drgokhanceylan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 22, 2023
• Study Start: September 18, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

TU (4)