Impact of High Flow Therapy on Complications Related to Airway Stenting

Not Applicable

Recruiting

• Conditions: Mucus; Plug; Respiratory Infection; Airway Obstruction
• Interventions: Device: High flow nasal cannula; Device: nebulized normal saline

• Registration Number: NCT06069817
• Lead Sponsor: Cardarelli Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-06
• Study Start: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-10
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow nasal cannula group	High flow nasal cannula	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.
nebulized saline group	nebulized normal saline	Treatment with nebulization of 4-8 cc of normal saline three times daily

Primary Outcome Measures

Name	Time	Method
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
incidence of mucous plugging associated with airway stent in nebulized saline group	within 60 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 90 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 mucous plugging associated with airway stent in HFNC group	within 90 days from stent placement	mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area

Secondary Outcome Measures

Name	Time	Method
all cause-mortality in nebulized saline group	within 90 days from stent placement
mortality due to respiratory infection in nebulized saline group	within 90 days from stent placement
mortality due to respiratory infection 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
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
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)
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 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)
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

Trial Locations

Locations (1)

Interventional Pulmonology Unit, Cardarelli Hospital; 🇮🇹 Napoli, Italy