Impact of High Flow Therapy on Complications Related to Airway Stenting

Study Overview
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Brief Summary
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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.

Official Title
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Impact of High Flow Therapy Through Nasal Cannula on Complications Related to Airway Stenting: a Prospective, Multicentric, Randomized-controlled Trial

Conditions
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Airway Obstruction, Respiratory Infection, Mucus; Plug

Intervention / Treatment
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* Device: High flow nasal cannula
* Device: nebulized normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow nasal cannula group<br>Treatment with High Flow Nasal Cannula minimum twenty (20) minutes three times a day (one [1] hour a day in total) and up to 10 hours a day in total, according to patient's preferences. | Device: High flow nasal cannula<br>* home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction<br>|
| Active Comparator: nebulized saline group<br>Treatment with nebulization of 4-8 cc of normal saline three times daily | Device: nebulized normal saline<br>* home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of mucous plugging associated with airway stent in HFNC group | mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | within 90 days from stent placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization | minutes a day spent on HFNC | 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 | 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) | 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) | 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) | 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) | within 90 days from stent placement | 
| incidence of airway stent colonization in HFNC group | positive bronchial aspirate culture | within 90 days from stent placement | 
| incidence of airway stent colonization in nebulized saline group | positive bronchial aspirate culture | within 90 days from stent placement | 
| all cause-mortality in HFNC group |  | within 90 days from stent placement | 
| all cause-mortality in nebulized saline group |  | within 90 days from stent placement | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high flow nasal cannula, airway stent, nebulized saline