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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Electrical Impedance Tomography positive end-expiratory pressure titration

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayden Leeds, MD; Phone Number: 3233617939; Email: hleeds@chla.usc.edu
• Study Contact Backup: Name: Anoopindar Bhalla, MD; Phone Number: 323-361-7939; Email: abhalla@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Hayden Leeds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electrical Impedance Tomography positive end-expiratory pressure; Patients will be monitored using Electrical Impedance Tomography and the positive end-expiratory pressure titration tool as their positive end-expiratory pressure is adjusted according to a step wise positive end-expiratory pressure titration protocol.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid.	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Recruitability will be defined as the absolute reduction in the percentage of collapse when comparing the highest and lowest PEEP achieved, as measured by electrical impedence tomography.	Day 1
Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels	Using the electrical impedence tomography pulsatility filter/tool, a difference in systolic impendence, attributed to the cardiac cycle, can be calculated. This will be used as a surrogate for stroke volume and will be compared across PEEP levels.	Day 1
Change in static compliance across different PEEP levels during a PEEP titration	Static compliance is defined as the change in volume divided by the change in pressure during an inspiratory hold (when airflow is zero). It reflects the elastic properties of the lung and chest wall.	Day 1
Change in driving pressure across different PEEP levels during a PEEP titration	Driving pressure is the difference between the plateau pressure (the pressure measured during an inspiratory hold, when airflow is zero) and the positive end-expiratory pressure (PEEP). It represents the pressure that actually distends the alveoli during mechanical ventilation.	Day 1
Change in plateau pressure across different PEEP levels during a PEEP titration	Plateau pressure is the pressure measured during an inspiratory hold maneuver, which occurs when the ventilator temporarily halts airflow at the end of the inspiratory phase. This allows the pressure in the alveoli to stabilize, providing a true reflection of the pressure needed to distend the lungs, without the effects of airflow resistance.	Day 1
Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration	For patients who consent to the optional placement of a volumetric capnography device, dead space will be continuously measured using volumetric capnography by measuring the volume of carbon dioxide (CO2) exhaled with each breath (VeCO2) and calculating the CO2 ventilatory equivalent (minute ventilation/VCO2). Airway dead space can be obtained with each breath.	Day 1
Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration	For patients who consent to the optional component of having an esophageal balloon catheter placed, esophageal manometry will be used to measure transplural pressure. The difference between the pressure in the alveoli (intrapulmonary pressure) and the pressure in the pleural space (intrapleural pressure). It reflects the pressure required to expand the lungs and is crucial for understanding lung mechanics. This will be obtained using esophageal manometry with inspiratory and expiratory holds at each PEEP titration level.	Day 1

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Study Director: Anoopindar Bhalla, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: respiratory distress; positive end-expiratory pressure; Electrical Impedance Tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: CHLA-24-00295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No