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

NCT06684119 | Recruiting

• 1 other identifier: CHLA-24-00295
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Acute Respiratory Distress Syndrome

Keywords

positive end-expiratory pressure; Electrical Impedance Tomography; respiratory distress

Outcome Measures

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.

  Day 1

Secondary Outcomes (7)

• 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

Study Arms (1)

Electrical Impedance Tomography positive end-expiratory pressure

EXPERIMENTAL

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

Interventions

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.

Electrical Impedance Tomography positive end-expiratory pressure

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any person who is less than 18 years of age
• is on invasive mechanical ventilation
• is not spontaneously breathing
• meets PARDS criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anoopindar Bhalla, MD

  Children's Hospital Los Angeles

  STUDY DIRECTOR

Central Study Contacts

Hayden Leeds, MD

CONTACT

3233617939; hleeds@chla.usc.edu

Anoopindar Bhalla, MD

CONTACT

323-361-7939; abhalla@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)