Clinical trial NCT06836050: IPV and Lung Compliance in Invasively Ventilated Children
Official title: The Effect of Intrapulmonary Percussive Ventilation (IPV) on Lung Compliance in Critically Ill Pediatric Patients Requiring Invasive Mechanical Ventilation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Steven and Alexandra Cohen Children's Medical Center
First posted: 2025-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Dynamic Compliance
timeFrame: Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment
Secondary outcomes:
measure: Static Compliance (when applicable)
timeFrame: Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
Study officials:
affiliation: Northwell Health
name: Todd Sweberg, MD
role: PRINCIPAL_INVESTIGATOR
References: