Clinical trial NCT06684119: Pediatric Positive End Expiratory Pressure (PEEP) Titration Using Electrical Impedence Tomography (EIT)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Acute Respiratory Distress Syndrome
Keywords: positive end-expiratory pressure
Electrical Impedance Tomography
respiratory distress
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid.
timeFrame: Day 1
Secondary outcomes:
measure: 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
timeFrame: Day 1
measure: Difference in systolic impendence, as a surrogate for cardiac output, using electrical impedence tomography at various PEEP levels
timeFrame: Day 1
measure: Change in static compliance across different PEEP levels during a PEEP titration
timeFrame: Day 1
measure: Change in driving pressure across different PEEP levels during a PEEP titration
timeFrame: Day 1
measure: Change in plateau pressure across different PEEP levels during a PEEP titration
timeFrame: Day 1
measure: Change in dead space, as measured by volumetric capnography, across different PEEP levels during a PEEP titration
timeFrame: Day 1
measure: Change in transplural pressure, as measured by esophageal manometry, across different PEEP levels during a PEEP titration
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Anoopindar Bhalla, MD
role: STUDY_DIRECTOR
References: