Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorDr. Behcet Uz Children's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fast method

    Other intervention

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

  • Conventional method

    Other intervention

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

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Fast decrementalExperimental treatment 1 intervention
Group B: ConventionalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Optimal catheter filling volume

The clinician will determine the optimal filling volume of the catheter using two distinct methods

Time frame
up 1 hour after catheter placement

Secondary outcomes

1

Transpulmonary driving pressure

The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter

Time frame
up 1 hour after catheter placement
2

Time

The duration necessary to ascertain the optimal filling volume of the esophageal catheter

Time frame
up 1 hour after catheter placement

Other outcomes

Sponsors and contacts

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