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NCT Number: NCT06684119

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

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.

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Key information

Conditions

Pediatric Acute Respiratory Distress Syndrome Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Hayden Leeds

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical Impedance Tomography positive end-expiratory pressure titration

Device

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 outcomes

  1. 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

  1. 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

    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.

  2. Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels

    Time frame: Day 1

    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.

  3. Change in static compliance across different PEEP levels during a PEEP titration

    Time frame: Day 1

    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.

  4. Change in driving pressure across different PEEP levels during a PEEP titration

    Time frame: Day 1

    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.

  5. Change in plateau pressure across different PEEP levels during a PEEP titration

    Time frame: Day 1

    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.

  6. Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration

    Time frame: Day 1

    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.

  7. Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anoopindar Bhalla, MD

CONTACT

[email protected]

323-361-7939

Hayden Leeds, MD

CONTACT

[email protected]

3233617939

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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