Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Acute Respiratory Distress Syndrome Clinical Trial

— DECFVTTPM  

Official title:

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051292
• Other study ID #: 02020395
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Dr. Behcet Uz Children's Hospital
• Contact: Hasan Agin, Professor
• Phone: 05362013162
• Email: hasanagin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Syndrome

Intervention

Other:
• Fast method
Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
• Conventional method
Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements

Locations

Country	Name	City	State
Turkey	Aydin Obstetric and pediatrics Hospital	Aydin
Turkey	Erzurum Regional Research and Training Hospital	Erzurum
Turkey	Cam Sakura Research and Training Hospital	Istanbul
Turkey	The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Transpulmonary driving pressure	The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter	up 1 hour after catheter placement
Secondary	Time	The duration necessary to ascertain the optimal filling volume of the esophageal catheter	up 1 hour after catheter placement