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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 13, 2024
February 1, 2024
10 months
September 25, 2023
February 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
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 Outcomes (12)
adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization
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
incidence of adverse events due to home treatment with HFNC in patients with airway stent
within 90 days from stent placement
incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent
within 90 days from stent placement
Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q)
within 90 days from stent placement
- +7 more secondary outcomes
Study Arms (2)
High flow nasal cannula group
EXPERIMENTALTreatment 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
ACTIVE COMPARATORTreatment with nebulization of 4-8 cc of normal saline three times daily
Interventions
home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction
Eligibility Criteria
You may qualify if:
- Written informed consent
- Central Airway obstruction, both malignant and nonmalignant, treated with airway stenting (silicone or fully covered metallic stent)
You may not qualify if:
- Contraindication to HFNC (recent - within 3 months - nose surgery or facial trauma)
- Lack of written informed consent
- Neuropsychiatric disorders
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Interventional Pulmonology Unit, Cardarelli Hospital
Napoli, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Interventional Pulmonology Unit
Study Record Dates
First Submitted
September 25, 2023
First Posted
October 6, 2023
Study Start
January 1, 2024
Primary Completion
November 1, 2024
Study Completion
December 31, 2024
Last Updated
February 13, 2024
Record last verified: 2024-02