The Use of Visual Feedback in Airway Clearance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546779
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Device: Tri-Gym Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. lung function [ Time Frame: fifteen minutes after intervention ]
    Forced expiratory maneuvers were measured before and 15 minutes after intervention.

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cystic fibrosis patients

Exclusion Criteria:

  • i.v. antibiotic therapy during the experiment day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546779

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

Responsible Party: Sheba Medical Center Identifier: NCT01546779     History of Changes
Other Study ID Numbers: SHEBA-08-5583-OE-CTIL
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

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