IPV and Lung Compliance in Invasively Ventilated Children

Recruiting

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

• Registration Number: NCT06836050
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cohen Children's Medical Center; 🇺🇸 New Hyde Park, New York, United States