IPV vs CPT for Airway Clearance During CF Exacerbation

NCT03261219 | Withdrawn FDA Device

• 1 other identifier: IRB201700115
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary exacerbation. FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials because it is an acute indicator of worsening or improving lung function.

Conditions

Cystic Fibrosis; Airway Clearance Impairment

Outcome Measures

Primary Outcomes (1)

• FEV1 change

  change in FEV1 from baseline at admission

  duration of hospital stay (usually 10-14 days)

Secondary Outcomes (3)

• time to next admission

  from discharge to 6 months after discharge

• Patient Satisfaction with airway clearance modality

  10 minutes after each discharge during study period

• Length of admission

  usually 10-14 days

Study Arms (2)

Intrapulmonary Percussive ventilation

EXPERIMENTAL

Device: Intrapulmonary Percussive ventilation

Chest Physiotherapy vest

ACTIVE COMPARATOR

Device: Chest Physiotherapy Vest (Incourage)

Interventions

Intrapulmonary Percussive ventilation DEVICE

mode of airway clearance using mouthpiece and alternating air currents applied directly to the airway

Intrapulmonary Percussive ventilation

Chest Physiotherapy Vest (Incourage) DEVICE

mode of airway clearance using external vibratory vest

Chest Physiotherapy vest

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• CF patient admitted for pulmonary exacerbation

You may not qualify if:

• Patients who are not able to perform spirometry, patients with neurological impairment (Cerebral Palsy) or severe behavioral problems that precludes consistent use of IPV, patients with pneumothorax or significant hemoptysis, patients who require supplemental oxygen or ventilatory support, or patients whose parents/guardians are not willing to consent will be excluded.

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: July 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: October 30, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share