search
Back to results

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

Primary Purpose

Airway Obstruction, Respiratory Infection, Mucus; Plug

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High flow nasal cannula
nebulized normal saline
Sponsored by
Cardarelli Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring high flow nasal cannula, airway stent, nebulized saline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitari de Bellvitge
  • Hospital general universitario Santa lucia Universidad de Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow nasal cannula group

nebulized saline group

Arm Description

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.

Treatment with nebulization of 4-8 cc of normal saline three times daily

Outcomes

Primary Outcome Measures

incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in HFNC group
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of mucous plugging associated with airway stent in HFNC group
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
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
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
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in HFNC group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in nebulized saline group
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
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
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

Secondary Outcome Measures

adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization
minutes a day spent on HFNC
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
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)
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)
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)
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)
incidence of airway stent colonization in HFNC group
positive bronchial aspirate culture
incidence of airway stent colonization in nebulized saline group
positive bronchial aspirate culture
all cause-mortality in HFNC group
all cause-mortality in nebulized saline group
mortality due to respiratory infection in HFNC group
mortality due to respiratory infection in nebulized saline group

Full Information

First Posted
September 25, 2023
Last Updated
October 10, 2023
Sponsor
Cardarelli Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06069817
Brief Title
Impact of High Flow Therapy on Complications Related to Airway Stenting
Acronym
HiSTENT
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardarelli Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction, Respiratory Infection, Mucus; Plug
Keywords
high flow nasal cannula, airway stent, nebulized saline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High flow nasal cannula group
Arm Type
Experimental
Arm Description
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.
Arm Title
nebulized saline group
Arm Type
Active Comparator
Arm Description
Treatment with nebulization of 4-8 cc of normal saline three times daily
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction
Intervention Type
Device
Intervention Name(s)
nebulized normal saline
Intervention Description
home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction
Primary Outcome Measure Information:
Title
incidence of mucous plugging associated with airway stent in HFNC group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 7 days from stent placement
Title
incidence of mucous plugging associated with airway stent in HFNC group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 30 days from stent placement
Title
incidence of mucous plugging associated with airway stent in HFNC group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 60 days from stent placement
Title
incidence of mucous plugging associated with airway stent in HFNC group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 90 days from stent placement
Title
incidence of mucous plugging associated with airway stent in nebulized saline group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 7 days from stent placement
Title
incidence of mucous plugging associated with airway stent in nebulized saline group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 30 days from stent placement
Title
incidence of mucous plugging associated with airway stent in nebulized saline group
Description
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 60 days from stent placement
Title
incidence of granuloma associated with airway stent in HFNC group
Description
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 90 days from stent placement
Title
incidence of granuloma associated with airway stent in nebulized saline group
Description
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 7 days from stent placement
Title
incidence of granuloma associated with airway stent in nebulized saline group
Description
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 30 days from stent placement
Title
incidence of granuloma associated with airway stent in nebulized saline group
Description
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 60 days from stent placement
Title
incidence of granuloma associated with airway stent in nebulized saline group
Description
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
Time Frame
within 90 days from stent placement
Title
incidence of respiratory infection associated with airway stent in HFNC group
Description
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
Time Frame
within 90 days from stent placement
Title
incidence of respiratory infection associated with airway stent in nebulized saline group
Description
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
Time Frame
within 90 days from stent placement
Secondary Outcome Measure Information:
Title
adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization
Description
minutes a day spent on HFNC
Time Frame
within 90 days from stent placement
Title
adherence to home treatment with nebulization of normal saline in patients with airway stent, as assesed by time of daily utilization
Description
times a day spent on nebulization
Time Frame
within 90 days from stent placement
Title
incidence of adverse events due to home treatment with HFNC in patients with airway stent
Description
incidence of malfunction of the device; incidence of complications as assessed by clinical examination (cough, headache, rhinitis)
Time Frame
within 90 days from stent placement
Title
incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent
Description
incidence of malfunction of the device; incidence of complications as assessed by clinical examination (cough, headache, rhinitis)
Time Frame
within 90 days from stent placement
Title
Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q)
Description
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)
Time Frame
within 90 days from stent placement
Title
Satisfaction of home treatment with nebulized saline by Cough and sputum assessment questionnaire CASA-Q
Description
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)
Time Frame
within 90 days from stent placement
Title
incidence of airway stent colonization in HFNC group
Description
positive bronchial aspirate culture
Time Frame
within 90 days from stent placement
Title
incidence of airway stent colonization in nebulized saline group
Description
positive bronchial aspirate culture
Time Frame
within 90 days from stent placement
Title
all cause-mortality in HFNC group
Time Frame
within 90 days from stent placement
Title
all cause-mortality in nebulized saline group
Time Frame
within 90 days from stent placement
Title
mortality due to respiratory infection in HFNC group
Time Frame
within 90 days from stent placement
Title
mortality due to respiratory infection in nebulized saline group
Time Frame
within 90 days from stent placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Corcione, MD, PhD
Phone
+ 39 0817473393
Email
nadia.corcione@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Failla, MD
Organizational Affiliation
Ospedale "Antonio Cardarelli", Naples
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nadia Corcione, MD, PhD
Organizational Affiliation
Ospedale "Antonio Cardarelli", Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfonso Pecoraro, MD
Organizational Affiliation
Ospedale "Antonio Cardarelli", Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoni Rosell, Professor
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa Lopez, MD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Perez Pallares, MD
Organizational Affiliation
Hospital General Universitario Santa Lucia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Rosell, Professor
Email
arosellg.germanstrias@gencat.cat
First Name & Middle Initial & Last Name & Degree
Antoni Rosell
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Lopez, MD
Facility Name
Hospital general universitario Santa lucia Universidad de Murcia
City
Cartagena
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Perez Pallares, MD

12. IPD Sharing Statement

Learn more about this trial

Impact of High Flow Therapy on Complications Related to Airway Stenting

We'll reach out to this number within 24 hrs