Clinical trial NCT06069817: Impact of High Flow Therapy on Complications Related to Airway Stenting
Official title: Impact of High Flow Therapy Through Nasal Cannula on Complications Related to Airway Stenting: a Prospective, Multicentric, Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Obstruction
Respiratory Infection
Mucus; Plug
Keywords: high flow nasal cannula
airway stent
nebulized saline
Lead sponsor: Cardarelli Hospital
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of mucous plugging associated with airway stent in HFNC group
timeFrame: within 7 days from stent placement
measure: incidence of mucous plugging associated with airway stent in HFNC group
timeFrame: within 30 days from stent placement
measure: incidence of mucous plugging associated with airway stent in HFNC group
timeFrame: within 60 days from stent placement
measure: incidence of mucous plugging associated with airway stent in HFNC group
timeFrame: within 90 days from stent placement
measure: incidence of mucous plugging associated with airway stent in nebulized saline group
timeFrame: within 7 days from stent placement
measure: incidence of mucous plugging associated with airway stent in nebulized saline group
timeFrame: within 30 days from stent placement
measure: incidence of mucous plugging associated with airway stent in nebulized saline group
timeFrame: within 60 days from stent placement
measure: incidence of granuloma associated with airway stent in HFNC group
timeFrame: within 90 days from stent placement
measure: incidence of granuloma associated with airway stent in nebulized saline group
timeFrame: within 7 days from stent placement
measure: incidence of granuloma associated with airway stent in nebulized saline group
timeFrame: within 30 days from stent placement
measure: incidence of granuloma associated with airway stent in nebulized saline group
timeFrame: within 60 days from stent placement
measure: incidence of granuloma associated with airway stent in nebulized saline group
timeFrame: within 90 days from stent placement
measure: incidence of respiratory infection associated with airway stent in HFNC group
timeFrame: within 90 days from stent placement
measure: incidence of respiratory infection associated with airway stent in nebulized saline group
timeFrame: within 90 days from stent placement
Secondary outcomes:
measure: adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization
timeFrame: within 90 days from stent placement
measure: adherence to home treatment with nebulization of normal saline in patients with airway stent, as assesed by time of daily utilization
timeFrame: within 90 days from stent placement
measure: incidence of adverse events due to home treatment with HFNC in patients with airway stent
timeFrame: within 90 days from stent placement
measure: incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent
timeFrame: within 90 days from stent placement
measure: Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q)
timeFrame: within 90 days from stent placement
measure: Satisfaction of home treatment with nebulized saline by Cough and sputum assessment questionnaire CASA-Q
timeFrame: within 90 days from stent placement
measure: incidence of airway stent colonization in HFNC group
timeFrame: within 90 days from stent placement
measure: incidence of airway stent colonization in nebulized saline group
timeFrame: within 90 days from stent placement
measure: all cause-mortality in HFNC group
timeFrame: within 90 days from stent placement
measure: all cause-mortality in nebulized saline group
timeFrame: within 90 days from stent placement
measure: mortality due to respiratory infection in HFNC group
timeFrame: within 90 days from stent placement
measure: mortality due to respiratory infection in nebulized saline group
timeFrame: within 90 days from stent placement
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Interventional Pulmonology Unit, Cardarelli Hospital
Study officials:
affiliation: Ospedale "Antonio Cardarelli", Naples
name: Giuseppe Failla, MD
role: STUDY_DIRECTOR
affiliation: Ospedale "Antonio Cardarelli", Naples
name: Nadia Corcione, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale "Antonio Cardarelli", Naples
name: Alfonso Pecoraro, MD
role: PRINCIPAL_INVESTIGATOR
References: