Airway Obstruction, Respiratory Infection, Mucus; Plug
Conditions
Keywords
high flow nasal cannula, airway stent, nebulized saline
Brief summary
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.
Interventions
DEVICEHigh flow nasal cannula
home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
DEVICEnebulized normal saline
home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction
Sponsors
Cardarelli Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Central Airway obstruction, both malignant and nonmalignant, treated with airway stenting (silicone or fully covered metallic stent)
Exclusion criteria
* Contraindication to HFNC (recent - within 3 months - nose surgery or facial trauma) * Lack of written informed consent * Neuropsychiatric disorders * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of mucous plugging associated with airway stent in HFNC group | within 7 days from stent placement | mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area |
| incidence of mucous plugging associated with airway stent in nebulized saline group | within 7 days from stent placement | mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area |
| incidence of granuloma associated with airway stent in HFNC group | within 90 days from stent placement | granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area |
| incidence of granuloma associated with airway stent in nebulized saline group | within 7 days from stent placement | granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area |
| incidence of respiratory infection associated with airway stent in HFNC group | within 90 days from stent placement | symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy |
| incidence of respiratory infection associated with airway stent in nebulized saline group | within 90 days from stent placement | symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of airway stent colonization in HFNC group | within 90 days from stent placement | positive bronchial aspirate culture |
| incidence of airway stent colonization in nebulized saline group | within 90 days from stent placement | positive bronchial aspirate culture |
| all cause-mortality in HFNC group | within 90 days from stent placement | — |
| adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization | within 90 days from stent placement | minutes a day spent on HFNC |
| mortality due to respiratory infection in HFNC group | within 90 days from stent placement | — |
| mortality due to respiratory infection in nebulized saline group | within 90 days from stent placement | — |
| all cause-mortality in nebulized saline group | 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 | within 90 days from stent placement | times a day spent on nebulization |
| incidence of adverse events due to home treatment with HFNC in patients with airway stent | within 90 days from stent placement | incidence of malfunction of the device; incidence of complications as assessed by clinical examination (cough, headache, rhinitis) |
| incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent | within 90 days from stent placement | incidence of malfunction of the device; incidence of complications as assessed by clinical examination (cough, headache, rhinitis) |
| Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q) | within 90 days from stent placement | 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) |
| Satisfaction of home treatment with nebulized saline by Cough and sputum assessment questionnaire CASA-Q | within 90 days from stent placement | 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) |
Countries
Italy
Contacts
Primary ContactNadia Corcione, MD, PhD
Outcome results
None listed