Asociación Aragonesa de Fibrosis Quística
Zaragoza, Spain
NCT Number: NCT02303808
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Zaragoza, Spain
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.
During the study period the patients' pharmacological treatment remains unchanged
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
Time frame: 45 minutes
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
Time frame: 2 hours
2 hours wet sputum production (ml) after chest physiotherapy session
Time frame: 22 hours
22 hours wet sputum production (ml) after chest physiotherapy session
Time frame: 5 days
Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Time frame: 45 minutes
Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate
Time frame: 5 days
Likert test
Time frame: 5 days
Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S)
Universidad San Jorge
Other
Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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