Impact of High Flow Therapy on Complications Related to Airway Stenting (HiSTENT)

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

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 Overview

• Status: Recruiting
• Conditions: Airway Obstruction; Respiratory Infection; Mucus; Plug
• Intervention / Treatment: Device: High flow nasal cannula; Device: nebulized normal saline

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Corcione, MD, PhD; Phone Number: + 39 0817473393; Email: nadia.corcione@gmail.com

Study Locations

• Italy
  • Napoli, Italy
    • Recruiting
    • Interventional Pulmonology Unit, Cardarelli Hospital
    • Contact: Nadia Corcione, MD PhD; Email: nadia.corcione@gmail.com
    • Contact: Alfonso Pecoraro, MD; Email: alfonsopecoraro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow nasal cannula group; 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; home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
Active Comparator: nebulized saline group; Treatment with nebulization of 4-8 cc of normal saline three times daily	Device: nebulized normal saline; home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Cardarelli Hospital
• Investigators: Study Director: Giuseppe Failla, MD, Ospedale "Antonio Cardarelli", Naples; Principal Investigator: Nadia Corcione, MD, PhD, Ospedale "Antonio Cardarelli", Naples; Principal Investigator: Alfonso Pecoraro, MD, Ospedale "Antonio Cardarelli", Naples

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: high flow nasal cannula; airway stent; nebulized saline
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction; Respiratory Tract Infections
• Other Study ID Numbers: 1A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No