Impact of High Flow Therapy on Complications Related to Airway Stenting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Airway Obstruction Respiratory Infection Mucus; Plug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction

nebulized saline group

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

Group Type ACTIVE_COMPARATOR

nebulized normal saline

Intervention Type DEVICE

home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction

Interventions

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High flow nasal cannula

home treatment with HFNC after airway stent placement both for malignant and benignant central airway obstruction

Intervention Type DEVICE

nebulized normal saline

home treatment with nebulized normal saline after airway stent placement both for malignant and benignant central airway obstruction

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No