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Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vest Treatment (high frequency chest wall oscillation)
Sponsored by
Hill-Rom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy focused on measuring High Frequency Chest Wall Oscillation, Cerebral Palsy, Restrictive lung disease

Eligibility Criteria

18 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is at least 18 months old.
  • Subject has a chest circumference of greater than 19 inches.
  • Subject has a diagnosis of muscle weakness and restrictive lung disease.
  • Ability to provide Informed consent from legal guardian.
  • Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months
  • If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment

Exclusion Criteria:

  • Subject has a diagnosed allergy with a respiratory trigger.
  • Participation in another clinical trial.
  • Unstable head or spinal injury.
  • Unresolved pneumothorax or pneumomediastinum present
  • Unresolved hemorrhage
  • Hypotension requiring vasopressors or positioning
  • Bronchopleural fistula
  • Gross hemoptysis within the past eight hours
  • Pulmonary embolism or history of pulmonary embolism within the past two months
  • Burns, open wounds and skin infections on the thorax
  • Osteomyelitis of the ribs
  • Osteoporosis with history of fractures.

Sites / Locations

  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vest Treatment (HFCWO)

Arm Description

Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.

Outcomes

Primary Outcome Measures

Hospitalizations Lasting at Least 24 Hours in This Patient Population
Hospitalizations lasting at least 24 hours

Secondary Outcome Measures

Full Information

First Posted
August 20, 2008
Last Updated
July 7, 2017
Sponsor
Hill-Rom
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1. Study Identification

Unique Protocol Identification Number
NCT00739310
Brief Title
Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
Official Title
A Pilot Study to Assess the Efficacy and Effectiveness of High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations in Children With Muscle Weakness and Restrictive Lung Disease CR-0088
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.
Detailed Description
This non-randomized home based pre-post intervention study. The study will compare the efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations. Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory status as a pilot evaluation of microbial load and inflammatory status outcomes. The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be considered evaluable if they have completed at least 6 months of follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
High Frequency Chest Wall Oscillation, Cerebral Palsy, Restrictive lung disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vest Treatment (HFCWO)
Arm Type
Experimental
Arm Description
Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.
Intervention Type
Device
Intervention Name(s)
Vest Treatment (high frequency chest wall oscillation)
Other Intervention Name(s)
HFCWO
Intervention Description
twice daily for 15-20 minutes
Primary Outcome Measure Information:
Title
Hospitalizations Lasting at Least 24 Hours in This Patient Population
Description
Hospitalizations lasting at least 24 hours
Time Frame
end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 months old. Subject has a chest circumference of greater than 19 inches. Subject has a diagnosis of muscle weakness and restrictive lung disease. Ability to provide Informed consent from legal guardian. Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment Exclusion Criteria: Subject has a diagnosed allergy with a respiratory trigger. Participation in another clinical trial. Unstable head or spinal injury. Unresolved pneumothorax or pneumomediastinum present Unresolved hemorrhage Hypotension requiring vasopressors or positioning Bronchopleural fistula Gross hemoptysis within the past eight hours Pulmonary embolism or history of pulmonary embolism within the past two months Burns, open wounds and skin infections on the thorax Osteomyelitis of the ribs Osteoporosis with history of fractures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikail Kazachkov, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States

12. IPD Sharing Statement

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Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations

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