Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Device: Low FLow, 5 LPM (via Optiflow cannula)

Device: High-Flow, 20 LPM (via Optiflow cannula)

Study type

Interventional

Funder types

Other

Identifiers

NCT02129803

HM20002205

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

10 to 50 years old

Volunteers

No Healthy Volunteers

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.