Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-27 @ 8:36 AM
Study NCT ID:
NCT06836050
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPV and Lung Compliance in Invasively Ventilated Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic Compliance', 'timeFrame': 'Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment', 'description': "A measurement calculated and obtained from the patient's ventilator, averaged over 1 minute."}], 'secondaryOutcomes': [{'measure': 'Static Compliance (when applicable)', 'timeFrame': 'Baseline (15 minutes before IPV treatment), 15 minutes after IPV treatment, and 3 hours after IPV treatment', 'description': "A measurement calculated and obtained from the patient's ventilator using an inspiratory hold maneuver."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Compliance', 'Pediatric', 'Pediatric Acute Respiratory Distress Syndrome (PARDS)', 'Intrapulmonary Percussive Ventilation (IPV)'], 'conditions': ['Pediatric Acute Respiratory Distress Syndrome (PARDS)', 'Pediatric Respiratory Diseases', 'Lung Compliance']}, 'descriptionModule': {'briefSummary': "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:\n\n1. Does IPV improve lung compliance 15 minutes after and 3 hours after receiving one treatment in a heterogeneous group of pediatric patients?\n2. 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?\n3. What is the effect of IPV on lung compliance according to PARDS severity (mild-moderate disease vs. severe disease).\n4. What is the incidence of adverse effects of IPV?\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A heterogeneous population of pediatric patients \\<18 years old requiring conventional invasive mechanical ventilation and receiving IPV.\n\nWe 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≤18 years old on conventional intermittent mandatory ventilation in the PICU that the physician deems is a candidate for IPV\n\nExclusion Criteria:\n\n* The inability to accurately obtain ventilator measurements'}, 'identificationModule': {'nctId': 'NCT06836050', 'briefTitle': 'IPV and Lung Compliance in Invasively Ventilated Children', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'The Effect of Intrapulmonary Percussive Ventilation (IPV) on Lung Compliance in Critically Ill Pediatric Patients Requiring Invasive Mechanical Ventilation.', 'orgStudyIdInfo': {'id': 'IRB# 24-0830'}}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandra B Cummings, DO', 'role': 'CONTACT', 'email': 'acummingsdel@northwell.edu', 'phone': '631-223-6032'}, {'name': 'Alexandra B Cummings, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Todd Sweberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Layne Silveer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Cohen Children's Medical Center", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'centralContacts': [{'name': 'Alexandra B Cummings, DO', 'role': 'CONTACT', 'email': 'acummingsdel@northwell.edu', 'phone': '631-223-6032'}, {'name': 'Todd Sweberg, MD', 'role': 'CONTACT', 'email': 'tsweberg@northwell.edu', 'phone': '718-470-3668'}], 'overallOfficials': [{'name': 'Todd Sweberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': "Steven and Alexandra Cohen Children's Medical Center", 'class': 'INDIV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}