Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
NCT ID: NCT02129803
Last Updated: 2021-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-05-31
2019-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental Therapy
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
High-Flow, 20 LPM (via Optiflow cannula)
Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
Control Therapy (Low Flow)
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Low FLow, 5 LPM (via Optiflow cannula)
standard humidified wall medical air.
Interventions
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High-Flow, 20 LPM (via Optiflow cannula)
Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
Low FLow, 5 LPM (via Optiflow cannula)
standard humidified wall medical air.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
50 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Bruce K Rubin, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Children's Hospital of Richmond at VCU
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HM20002205
Identifier Type: -
Identifier Source: org_study_id
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