IPV and Lung Compliance in Invasively Ventilated Children

NCT ID: NCT06836050

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2026-12-31

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. 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven and Alexandra Cohen Children's Medical Center

INDIV

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Sweberg, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Cohen Children's Medical Center

New Hyde Park, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandra B Cummings, DO

Role: CONTACT

acummingsdel@northwell.edu

631-223-6032

Todd Sweberg, MD

Role: CONTACT

tsweberg@northwell.edu

718-470-3668

Facility Contacts

Alexandra B Cummings, DO

Role: primary

acummingsdel@northwell.edu

631-223-6032

Other Identifiers

IRB# 24-0830

Identifier Type: -

Identifier Source: org_study_id