Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Virginia Commonwealth University24 enrolled

Overview

This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

High-Flow, 20 LPM (via Optiflow cannula)DEVICE

Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.

Low FLow, 5 LPM (via Optiflow cannula)DEVICE

standard humidified wall medical air.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of CF * Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10) * 10 years of age and older * Subject is able to comply with the procedures scheduled in the protocol * Signed informed consent form Exclusion Criteria: * Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment * Subject had ear, nose, and throat (ENT) surgery, nasal bleeding, or nasal polyps within 6 months prior to study * Subject is unlikely to comply with the procedures scheduled in the protocol * Inability to give informed consent * Subject requires supplemental oxygen * History of obstructive sleep apnea * History of pressure headaches requiring therapy within one month of enrollment * Any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.

Locations (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)

The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.

Time frame: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first

Secondary Outcomes

Sputum Collection

Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.

Time frame: 10 minutes

Data from ClinicalTrials.gov

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