Recruiting

PEEP Titration

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06684119

Conditions

Pediatric Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Electrical Impedance Tomography positive end-expiratory pressure titration

Study Details

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

Study ID

NCT06684119

Start date

Dec 10, 2024

Status verified date

Dec, 2024

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome 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. [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Hayden Leeds, MD

3233617939hleeds@chla.usc.edu

Anoopindar Bhalla, MD

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

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Feb 7, 2025

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-02-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.