Pediatric Acute Respiratory Distress Syndrome (PARDS)NCT06836050
IPV and Lung Compliance in Invasively Ventilated Children
An observational study of Pediatric Acute Respiratory Distress Syndrome (PARDS) and Pediatric Respiratory Diseases, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Pediatric Respiratory Diseases, Lung Compliance
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 12 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- ≤18 years old on conventional intermittent mandatory ventilation in the PICU that the physician deems is a candidate for IPV
Who cannot join
- The inability to accurately obtain ventilator measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
Cohen Children's Medical Center
New Hyde Park, New York, 11040
About this study
Official title: 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:
- Does IPV improve lung compliance 15 minutes after and 3 hours after receiving one treatment in a heterogeneous group of pediatric patients?
- 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?
- What is the effect of IPV on lung compliance according to PARDS severity (mild-moderate disease vs. severe disease).
- 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
- Keywords
- Lung Compliance, Pediatric, Pediatric Acute Respiratory Distress Syndrome (PARDS), Intrapulmonary Percussive Ventilation (IPV)
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Compliance
A measurement calculated and obtained from the patient's ventilator, averaged over 1 minute.
Measured: Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment
Secondary outcomes (1)
Static Compliance (when applicable)
A measurement calculated and obtained from the patient's ventilator using an inspiratory hold maneuver.
Measured: Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start13 Jan 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Respiratory Distress Syndrome (PARDS)Studies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Steven and Alexandra Cohen Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Todd Sweberg, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836050
- Sponsor's protocol ID
- IRB# 24-0830
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrapulmonary Percussive Ventilation (IPV) on Lung Compliance in Critically Ill Pediatric Patients Requiring Invasive Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT06836050
- Acronym / sponsor ID
- IRB# 24-0830
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Steven and Alexandra Cohen Children's Medical Center
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does IPV improve lung compliance 15 minutes after and 3 hours after receiving one treatment in a heterogeneous group of pediatric patients?
- 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?
- What is the effect of IPV on lung compliance according to PARDS severity (mild-moderate disease vs. severe disease).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- ≤18 years old on conventional intermittent mandatory ventilation in the PICU that the physician deems is a candidate for IPV
Key exclusion criteria (1 listed)
- The inability to accurately obtain ventilator measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic Compliance
Time frame: 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.
1 secondary outcome
Static Compliance (when applicable)
Time frame: Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Sweberg, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Acute Respiratory Distress Syndrome (PARDS) and Pediatric Respiratory Diseases, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Compliance (time frame: Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.