Impact of High Flow Therapy on Complications Related to Airway Stenting

Airway Obstruction Clinical Trial

— HiSTENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069817
• Other study ID #: 1A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Cardarelli Hospital
• Contact: Nadia Corcione, MD, PhD
• Phone: + 39 0817473393
• Email: nadia.corcione[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Device:
• High flow nasal cannula
home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
• nebulized normal saline
home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction

Locations

Country	Name	City	State
Italy	Interventional Pulmonology Unit, Cardarelli Hospital	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Cardarelli Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	incidence of airway stent colonization in HFNC group	positive bronchial aspirate culture	within 90 days from stent placement
Secondary	incidence of airway stent colonization in nebulized saline group	positive bronchial aspirate culture	within 90 days from stent placement
Secondary	all cause-mortality in HFNC group		within 90 days from stent placement
Secondary	all cause-mortality in nebulized saline group		within 90 days from stent placement
Secondary	mortality due to respiratory infection in HFNC group		within 90 days from stent placement
Secondary	mortality due to respiratory infection in nebulized saline group		within 90 days from stent placement