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

ConditionPediatric Acute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorChildren's Hospital Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any person who is less than 18 years of age

is on invasive mechanical ventilation

is not spontaneously breathing

meets PARDS criteria

Disqualifiers

Contraindication to the use of EIT

Hemodynamic instability

Contraindications to hypercapnia

patients with uncuffed endotracheal or tracheostomy tubes

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Electrical Impedance Tomography positive end-expiratory pressureExperimental treatment 1 intervention

Trial outcomes

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.

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.

Time frame
Day 1

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

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.

Time frame
Day 1
2

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.

Time frame
Day 1
3

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.

Time frame
Day 1
4

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.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

Source ClinicalTrials.gov
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