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Recruiting NCT06684119

Pediatric Positive End Expiratory Pressure (PEEP) Titration Using Electrical Impedence Tomography (EIT)

No phase Interventional Pediatric Acute Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical Impedance Tomography positive end-expiratory pressure titration.
Who it may be relevant to
Registry conditions: Pediatric Acute Respiratory Distress Syndrome. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Assessing Optimal Positive End-expiratory Pressure (PEEP) Using Electrical Impedance Tomography (EIT) During a PEEP Titration Protocol in Mechanically Ventilated Children with Pediatric Acute Respiratory Distress Syndrome (PARDS)

Overview

The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows: Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations. Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP. Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.

Interventions

  • Device Electrical Impedance Tomography positive end-expiratory pressure titration
    A PEEP titration will occur for the patient with the PEEP increased by 2 cm H2O every 2 minutes until a maximum PEEP of 20 or three steps (+ 6 cm H2O) above the set clinical PEEP. The PEEP will then be decreased by 2 cmH2O every 2 minutes until a minimum PEEP of 6 cmH2O or three steps (- 6 cm H2O) below their clinical PEEP.

Primary outcome measures

  • The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid. [Time frame: Day 1]
Secondary outcome measures (7)
  • Lung recruitability, as measured by electrical impedence tomography, and its association with difference in optimal PEEP recommended by electrical impedence tomography versus the PEEP/FiO2 grid [Time frame: Day 1]
  • Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels [Time frame: Day 1]
  • Change in static compliance across different PEEP levels during a PEEP titration [Time frame: Day 1]
  • Change in driving pressure across different PEEP levels during a PEEP titration [Time frame: Day 1]
  • Change in plateau pressure across different PEEP levels during a PEEP titration [Time frame: Day 1]
  • Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration [Time frame: Day 1]
  • Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Any person who is less than 18 years of age
  • is on invasive mechanical ventilation
  • is not spontaneously breathing
  • meets PARDS criteria

Exclusion criteria

  • Contraindication to the use of EIT
  • Hemodynamic instability
  • Contraindications to hypercapnia
  • patients with uncuffed endotracheal or tracheostomy tubes
  • diagnosis of pneumothorax or bronchopleural fistula
  • non-conventional ventilation
  • any patient on extra-corporeal membrane oxygenation (ECMO) support
  • less than 1 week post-operatively from cardiac surgery
  • the following cardiac diagnoses: Glenn or Fontan physiology, significant right to left shunt
  • Corrected Gestational Age < 37 weeks
  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Hospital Los Angeles — Los Angeles

Identifiers

NCT: NCT06684119 · CHLA-24-00295

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗