IPV and Lung Compliance in Invasively Ventilated Children

NCT06836050 | Recruiting

• 1 other identifier: IRB# 24-0830
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does IPV improve lung compliance 15 minutes after and 3 hours after receiving one treatment in a heterogeneous group of pediatric patients?
2. 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. 3.What is the effect of IPV on lung compliance according to PARDS severity (mild-moderate disease vs. severe disease).
4. 4.What is the incidence of adverse effects of IPV?

Conditions

Pediatric Acute Respiratory Distress Syndrome (PARDS); Pediatric Respiratory Diseases; Lung Compliance

Keywords

Lung Compliance; Pediatric; Pediatric Acute Respiratory Distress Syndrome (PARDS); Intrapulmonary Percussive Ventilation (IPV)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Static Compliance (when applicable)

  Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• The inability to accurately obtain ventilator measurements

Sponsors & Collaborators

• Northwell Health: lead
• Steven and Alexandra Cohen Children's Medical Center: collaborator

Study Sites (1)

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Study Officials

• Todd Sweberg, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra B Cummings, DO

CONTACT

631-223-6032; acummingsdel@northwell.edu

Todd Sweberg, MD

CONTACT

718-470-3668; tsweberg@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 20, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)