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Clinical Trials/NCT06684119
NCT06684119
Recruiting
Not Applicable

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)

Children's Hospital Los Angeles1 site in 1 country60 target enrollmentDecember 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Acute Respiratory Distress Syndrome
Sponsor
Children's Hospital Los Angeles
Enrollment
60
Locations
1
Primary Endpoint
The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2024
End Date
July 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anoopindar Bhalla

Medical Staff/USC Faculty

Children's Hospital Los Angeles

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

Outcomes

Primary Outcomes

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

Collected using electrical impedence tomography (EIT). The EIT device provides the percentages of alveolar overdistention and collapse at each PEEP level. The best PEEP by EIT is defined as the PEEP level above the intersection of curves representing relative alveolar overdistention and collapse.

Secondary Outcomes

  • 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(Day 1)
  • Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels(Day 1)
  • Change in static compliance across different PEEP levels during a PEEP titration(Day 1)
  • Change in driving pressure across different PEEP levels during a PEEP titration(Day 1)
  • Change in plateau pressure across different PEEP levels during a PEEP titration(Day 1)
  • Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration(Day 1)
  • Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration(Day 1)

Study Sites (1)

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