Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF

Stanford University25 enrolled

Overview

It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

The investigators hope to enroll 25 patients with cystic fibrosis (with daily sputum production) in this study. It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Electro-Flo InterventionDEVICE

An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines

G5 InterventionDEVICE

An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of CF established by standard criteria (sweat chloride \> 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF). 2. Age older than 8 years. 3. Known to consistently produce sputum. 4. Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily. 5. FEV1 \> 30%-predicted, and with stable lung function Exclusion Criteria: 1. Hospitalization for CF pulmonary complications in the 1 months preceding enrollment. 2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment. 3. Chronic chest pain. 4. Participation in another interventional clinical trial in the previous 30 days.

Outcomes

Primary Outcomes

Wet Sputum Weight

To compare the wet to dry weight of study patients' sputum collected during their Day 1 \& Day 2 therapy sessions.