IPV and Lung Compliance in Invasively Ventilated Children

The Effect of Intrapulmonary Percussive Ventilation (IPV) on Lung Compliance in Critically Ill Pediatric Patients Requiring Invasive Mechanical Ventilation.

The goal of this observational study is to determine if Intrapulmonary Percussive Ventilation (IPV) improves lung compliance in children receiving conventional invasive mechanical ventilation. The main questions it aims to answer are:

1. Does IPV improve lung compliance 15 minutes after and 3 hours after receiving one treatment in a heterogeneous group of pediatric patients?
2. Does IPV improve lung compliance in patients with Pediatric Acute Respiratory Distress Syndrome (PARDS), and what is the degree of change compared to those without PARDS?
3. What is the effect of IPV on lung compliance according to PARDS severity (mild-moderate disease vs. severe disease).
4. What is the incidence of adverse effects of IPV?

Participants will receive IPV because their medical team feels it will help their lung recovery and has already determined them to be safe candidates to receive this therapy, which is a standard airway clearance modality already routinely used in our PICU. Nothing additional will happen to participants as a result of this study. Enrolling in this study simply gives the study team permission to collect specific health information that identifies your child for research purposes, which may include results from medical tests found in their medical record and information from your child's bedside monitor and ventilator. This information will be collected before and after the IPV treatments to evaluate their response to the therapy.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Respiratory Diseases; Lung Compliance; Pediatric Acute Respiratory Distress Syndrome (PARDS)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Todd Sweberg, MD; Phone Number: 718-470-3668; Email: tsweberg@northwell.edu
• Study Contact Backup: Name: Alexandra B Cummings, DO; Phone Number: 631-223-6032; Email: acummingsdel@northwell.edu

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Cohen Children's Medical Center
      • Principal Investigator: Todd Sweberg, MD
      • Contact: Alexandra B Cummings, DO; Phone Number: 631-223-6032; Email: acummingsdel@northwell.edu
      • Sub-Investigator: Alexandra B Cummings, DO
      • Sub-Investigator: Layne Silveer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A heterogeneous population of pediatric patients <18 years old requiring conventional invasive mechanical ventilation and receiving IPV.

We will also specifically identify and observe patients who meet criteria for Pediatric Acute Respiratory Distress Syndrome (PARDS) and compare the effects of IPV on lung compliance in this group relative to those without PARDS.

Description

Inclusion Criteria:

• ≤18 years old on conventional intermittent mandatory ventilation in the PICU that the physician deems is a candidate for IPV

Exclusion Criteria:

• The inability to accurately obtain ventilator measurements

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Compliance	A measurement calculated and obtained from the patient's ventilator, averaged over 1 minute.	Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Compliance (when applicable)	A measurement calculated and obtained from the patient's ventilator using an inspiratory hold maneuver.	Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Steven and Alexandra Cohen Children's Medical Center
• Investigators: Principal Investigator: Todd Sweberg, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Pediatric Acute Respiratory Distress Syndrome (PARDS); Lung Compliance; Intrapulmonary Percussive Ventilation (IPV)
• Additional Relevant MeSH Terms: Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Tract Diseases; Acute Lung Injury; Respiration Disorders
• Other Study ID Numbers: IRB# 24-0830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No