Airway ObstructionHiSTENTNCT06069817
Impact of High Flow Therapy on Complications Related to Airway Stenting
A study testing High flow nasal cannula and nebulized normal saline in people with Airway Obstruction and Respiratory Infection, run by Cardarelli Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Obstruction, Respiratory Infection, Mucus; Plug
- What is being tested?
- High flow nasal cannula and nebulized normal saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Central Airway obstruction, both malignant and nonmalignant, treated with airway stenting (silicone or fully covered metallic stent)
Who cannot join
- Contraindication to HFNC (recent - within 3 months - nose surgery or facial trauma)
- Lack of written informed consent
- Neuropsychiatric disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Interventional Pulmonology Unit, Cardarelli Hospital
Naples
Nadia Corcione, MD PhD, nadia.corcione@gmail.com
Alfonso Pecoraro, MD, alfonsopecoraro@gmail.com
About this study
Official title: 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.
- Conditions
- Airway Obstruction, Respiratory Infection, Mucus; Plug
- Being tested
- High flow nasal cannula, nebulized normal saline
- Keywords
- high flow nasal cannula, airway stent, nebulized saline
- Medical subject headings
- Airway Obstruction, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
nebulized normal salineDevice
home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula group | Experimental | 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. Receives: Device: High flow nasal cannula |
| nebulized saline group | Active comparator | Treatment with nebulization of 4-8 cc of normal saline three times daily Receives: Device: nebulized normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
minutes a day spent on HFNC
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: within 90 days from stent placement
incidence of airway stent colonization in HFNC group
positive bronchial aspirate culture
Measured: within 90 days from stent placement
incidence of airway stent colonization in nebulized saline group
positive bronchial aspirate culture
Measured: within 90 days from stent placement
all cause-mortality in HFNC group
Measured: within 90 days from stent placement
all cause-mortality in nebulized saline group
Measured: within 90 days from stent placement
mortality due to respiratory infection in HFNC group
Measured: within 90 days from stent placement
mortality due to respiratory infection in nebulized saline group
Measured: within 90 days from stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Failla, Cardarelli Hospital
- Investigators
- Giuseppe Failla, MD, Study director, Ospedale "Antonio Cardarelli", NaplesNadia Corcione, MD, PhD, Principal investigator, Ospedale "Antonio Cardarelli", NaplesAlfonso Pecoraro, MD, Principal investigator, Ospedale "Antonio Cardarelli", Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069817
- Sponsor's protocol ID
- 1A
- Acronym
- HiSTENT
- Status last verified
- Feb 2024
- First submitted
- 25 Sep 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Flow Therapy Through Nasal Cannula on Complications Related to Airway Stenting: a Prospective, Multicentric, Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT06069817
- Acronym / sponsor ID
- HiSTENT / 1A
- Conditions
- Airway Obstruction, Respiratory Infection, Mucus; Plug
- Keywords
- high flow nasal cannula, airway stent, nebulized saline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula group | Experimental | Device: High flow nasal cannulaTreatment 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 comparator | Device: nebulized normal salineTreatment with nebulization of 4-8 cc of normal saline three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Central Airway obstruction, both malignant and nonmalignant, treated with airway stenting (silicone or fully covered metallic stent)
Key exclusion criteria (4 listed)
- Contraindication to HFNC (recent - within 3 months - nose surgery or facial trauma)
- Lack of written informed consent
- Neuropsychiatric disorders
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannulahome treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction | Device | High flow nasal cannula group |
| nebulized normal salinehome treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction | Device | nebulized saline group |
Primary outcome
incidence of mucous plugging associated with airway stent in HFNC group
Time frame: within 7 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in HFNC group
Time frame: within 30 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in HFNC group
Time frame: within 60 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in HFNC group
Time frame: within 90 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in nebulized saline group
Time frame: within 7 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in nebulized saline group
Time frame: within 30 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in nebulized saline group
Time frame: 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
Time frame: 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
Time frame: within 7 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
Time frame: within 30 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
Time frame: within 60 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
Time frame: 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
Time frame: within 90 days from stent placement
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
incidence of respiratory infection associated with airway stent in nebulized saline group
Time frame: within 90 days from stent placement
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
12 secondary outcomes
adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization
Time frame: 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
Time frame: within 90 days from stent placement
incidence of adverse events due to home treatment with HFNC in patients with airway stent
Time frame: within 90 days from stent placement
incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent
Time frame: within 90 days from stent placement
Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q)
Time frame: within 90 days from stent placement
Satisfaction of home treatment with nebulized saline by Cough and sputum assessment questionnaire CASA-Q
Time frame: within 90 days from stent placement
incidence of airway stent colonization in HFNC group
Time frame: within 90 days from stent placement
incidence of airway stent colonization in nebulized saline group
Time frame: within 90 days from stent placement
all cause-mortality in HFNC group
Time frame: within 90 days from stent placement
all cause-mortality in nebulized saline group
Time frame: within 90 days from stent placement
mortality due to respiratory infection in HFNC group
Time frame: within 90 days from stent placement
mortality due to respiratory infection in nebulized saline group
Time frame: within 90 days from stent placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Failla, MD study director
Ospedale "Antonio Cardarelli", Naples
Nadia Corcione, MD, PhD principal investigator
Ospedale "Antonio Cardarelli", Naples
Alfonso Pecoraro, MD principal investigator
Ospedale "Antonio Cardarelli", Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula and nebulized normal saline in people with Airway Obstruction and Respiratory Infection, run by Cardarelli Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Corcione, MD, PhD (+ 39 0817473393, nadia.corcione@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of mucous plugging associated with airway stent in HFNC group (time frame: within 7 days from stent placement). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.