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

NCT ID: NCT06684119

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electrical Impedance Tomography positive end-expiratory pressure titration

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Anoopindar Bhalla

Medical Staff/USC Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anoopindar Bhalla, MD

Role: STUDY_DIRECTOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hayden Leeds, MD

Role: CONTACT

3233617939

Anoopindar Bhalla, MD

Role: CONTACT

323-361-7939

Facility Contacts

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Hayden Leeds

Role: primary

Other Identifiers

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CHLA-24-00295

Identifier Type: -

Identifier Source: org_study_id

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