Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures

University of Cape Town (UCT)

Status: Completed

Conditions: Tracheal Stenosis

Treatments: Device: improved tracheal balloon dilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT02796326

UCTAnaes-2016-01

Details and patient eligibility

About

The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.

Full description

The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Symptoms of tracheal or laryngeal stenosis or airway narrowing
• Endoscopic evidence of subglottic or tracheal stenosis
• Able to provide informed consent

Exclusion criteria

• Refractory stenosis not amenable to balloon dilatation
• Contraindication to balloon dilatation
• Lack of informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dilatation

Experimental group

Description:

Patients undergoing tracheal dilatation with the study device

Treatment:

Device: improved tracheal balloon dilatation