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

Conditions

• Pediatric Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex

ALL

Age

0 Years - 18 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Dec 10, 2024

Status verified

Dec 2024

Primary completion

Jan 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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

• Hayden Leeds, MD
  3233617939
  [email protected]
• Anoopindar Bhalla, MD
  323-361-7939
  [email protected]

Locations (1)

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