The Use of Visual Feedback in Airway Clearance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01546779
First received: February 19, 2012
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing strategies, to clear secretions from their lungs. Hand held devices may aid mucus expectoration, and also motivate the patient to manage by themselves. Our aims was to study if resistive expiration through "volumetric incentive spirometer" (VISex) can improve lung function in the short term in Cystic Fibrosis (CF) patients.


Condition Intervention
Cystic Fibrosis
Device: Tri-Gym

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Immediate Effect of Resistive Expiration Via "Volumetric Incentive Spirometer" on Lung Function in Patients With Cystic Fibrosis.

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • lung function [ Time Frame: fifteen minutes after intervention ] [ Designated as safety issue: No ]
    Forced expiratory maneuvers were measured before and 15 minutes after intervention.


Enrollment: 40
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lung function Device: Tri-Gym
40 CF patients performed airway clearance using the VISex, by exhaling against chosen resistance being motivated by visual feedback of raising colored balls. The level of resistance was set to cause longest expiration/volume, until mucus was transported from the peripheral to the central airways, to be expectorated by the subsequent cough.
Other Name: incentive spirometer

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cystic fibrosis patients

Exclusion Criteria:

  • i.v. antibiotic therapy during the experiment day
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01546779

Locations
Israel
The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01546779     History of Changes
Other Study ID Numbers: SHEBA-08-5583-OE-CTIL
Study First Received: February 19, 2012
Last Updated: March 1, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014