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

Cardarelli Hospital

Status: Enrolling

Conditions: Airway Obstruction; Respiratory Infection; Mucus; Plug

Treatments: Device: nebulized normal saline; Device: High flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT06069817

1A

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

High flow nasal cannula group

Experimental group

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:

Device: High flow nasal cannula

nebulized saline group

Active Comparator group

Description:

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

Treatment:

Device: nebulized normal saline