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

February 10, 2024 updated by: Giuseppe Failla, Cardarelli Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 7 days from stent placement
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
within 30 days from stent placement
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
within 60 days from stent placement
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
within 90 days from stent placement
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
within 7 days from stent placement
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
within 30 days from stent placement
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
within 60 days from stent placement
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
within 90 days from stent placement
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
within 7 days from stent placement
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
within 30 days from stent placement
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
within 60 days from stent placement
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
within 90 days from stent placement
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
within 90 days from stent placement
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
within 90 days from stent placement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: within 90 days from stent placement
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
Time Frame: within 90 days from stent placement
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
Time Frame: within 90 days from stent placement
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
Time Frame: within 90 days from stent placement
positive bronchial aspirate culture
within 90 days from stent placement
incidence of airway stent colonization in nebulized saline group
Time Frame: within 90 days from stent placement
positive bronchial aspirate culture
within 90 days from stent placement
all cause-mortality in HFNC group
Time Frame: within 90 days from stent placement
within 90 days from stent placement
all cause-mortality in nebulized saline group
Time Frame: within 90 days from stent placement
within 90 days from stent placement
mortality due to respiratory infection in HFNC group
Time Frame: within 90 days from stent placement
within 90 days from stent placement
mortality due to respiratory infection in nebulized saline group
Time Frame: within 90 days from stent placement
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
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
Time Frame: within 90 days from stent placement
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardarelli Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings