DECFVTTPM: Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Sponsor

Dr. Behcet Uz Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06051292

Collaborator

(none)

Enrollment

Locations

Arms

3.4

Anticipated Duration (Months)

6.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Acute Respiratory Distress Syndrome (PARDS) Acute Respiratory Failure Acute Respiratory Distress Syndrome	Other: Fast method Other: Conventional method	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Anticipated Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Optimal catheter filling volume [up 1 hour after catheter placement]
The clinician will determine the optimal filling volume of the catheter using two distinct methods

Secondary Outcome Measures

Transpulmonary driving pressure [up 1 hour after catheter placement]
The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter
Time [up 1 hour after catheter placement]
The duration necessary to ascertain the optimal filling volume of the esophageal catheter

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Aydin Obstetric and pediatrics Hospital	Aydın	Turkey	09020
2	Erzurum Regional Research and Training Hospital	Erzurum	Turkey	25180
3	Cam Sakura Research and Training Hospital	Istanbul	Turkey	34001
4	The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital	Izmir	Turkey	35200