The application of HFNC therapy in patients with airway stent, improving both humidification and clearance of the airway secretion, could potentially reduce the risk of mucoid impaction, respiratory infections and granulation. HFNC therapy could be superior to nebulization of normal saline (usual care) in order to keep the stent cleaned, reducing, by inference, the risk of complications, as defined above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction
Interventional Pulmonology Unit, Cardarelli Hospital
Napoli, Italy
RECRUITINGincidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 7 days from stent placement
incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 30 days from stent placement
incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 60 days from stent placement
incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 90 days from stent placement
incidence of mucous plugging associated with airway stent in nebulized saline group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 7 days from stent placement
incidence of mucous plugging associated with airway stent in nebulized saline group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 30 days from stent placement
incidence of mucous plugging associated with airway stent in nebulized saline group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
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Time frame: within 60 days from stent placement
incidence of granuloma associated with airway stent in HFNC group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 90 days from stent placement
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 7 days from stent placement
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 30 days from stent placement
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 60 days from stent placement
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time frame: within 90 days from stent placement
incidence of respiratory infection associated with airway stent in HFNC group
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
Time frame: within 90 days from stent placement
incidence of respiratory infection associated with airway stent in nebulized saline group
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
Time frame: within 90 days from stent placement
adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization
minutes a day spent on HFNC
Time frame: within 90 days from stent placement
adherence to home treatment with nebulization of normal saline in patients with airway stent, as assesed by time of daily utilization
times a day spent on nebulization
Time frame: within 90 days from stent placement
incidence of adverse events due to home treatment with HFNC in patients with airway stent
incidence of malfunction of the device; incidence of complications as assessed by clinical examination (cough, headache, rhinitis)
Time frame: within 90 days from stent placement
incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent
incidence of malfunction of the device; incidence of complications as assessed by clinical examination (cough, headache, rhinitis)
Time frame: within 90 days from stent placement
Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q)
Cough and sputum assessment questionnaire (CASA-Q) to evaluate both severity of cough and sputum production to quality of life impairment (minimum value 0, maximum value 100; higher scores mean worse outcome)
Time frame: within 90 days from stent placement
Satisfaction of home treatment with nebulized saline by Cough and sputum assessment questionnaire CASA-Q
Cough and sputum assessment questionnaire (CASA-Q) to evaluate both severity of cough and sputum production to quality of life impairment (minimum value 0, maximum value 100; higher scores mean worse outcome)
Time frame: within 90 days from stent placement
incidence of airway stent colonization in HFNC group
positive bronchial aspirate culture
Time frame: within 90 days from stent placement
incidence of airway stent colonization in nebulized saline group
positive bronchial aspirate culture
Time frame: within 90 days from stent placement
all cause-mortality in HFNC group
Time frame: within 90 days from stent placement
all cause-mortality in nebulized saline group
Time frame: within 90 days from stent placement
mortality due to respiratory infection in HFNC group
Time frame: within 90 days from stent placement
mortality due to respiratory infection in nebulized saline group
Time frame: within 90 days from stent placement