The Use of Visual Feedback in Airway Clearance

Cystic Fibrosis Clinical Trial

Official title:

The Immediate Effect of Resistive Expiration Via "Volumetric Incentive Spirometer" on Lung Function in Patients With Cystic Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546779
• Other study ID #: SHEBA-08-5583-OE-CTIL
• Status: Completed
• Phase: N/A
• First received: February 19, 2012
• Last updated: March 1, 2012
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria:

• cystic fibrosis patients

Exclusion Criteria:

• i.v. antibiotic therapy during the experiment day

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Israel	The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung function	Forced expiratory maneuvers were measured before and 15 minutes after intervention.	fifteen minutes after intervention	No