Prospective Observational Trial of a Nonocclusive Dilatation Balloon in the Management of Tracheal Stenosis.

ABSTRACT

OBJECTIVES: Tracheal stenosis is a debilitating condition that often presents as an emergency and is challenging to treat. Dilatation may avoid tracheostomy or costly tracheal resection and reconstruction. Traditional dilators cause complete occlusion, preventing oxygenation and ventilation, limiting the safe duration of dilatation, and increasing the risk of hypoxic injury or barotrauma. The study authors here assessed an innovative nonocclusive tracheal dilatation balloon, which may improve patient safety by allowing continuous gas exchange. DESIGN: A prospective observational study of 20 discrete dilatation procedures performed in 13 patients under general anesthesia. The primary outcomes were the ability to ventilate during dilatation and the preservation of peripheral oxygen saturation. Secondary outcomes included a measured reduction in stenosis, improvement in Cotton-Myer grading, and procedure-related adverse events. SETTING: At a single university (academic) hospital. PARTICIPANTS: Consenting adult patients with acquired tracheal stenosis. INTERVENTIONS: Access to the airway was maintained by a rigid bronchoscope or supraglottic airway device, as deemed appropriate. Continuous conventional ventilation was provided during 3-minute balloon dilatations. MEASUREMENTS AND MAIN RESULTS: Heart rate, airway pressure, end-tidal carbon dioxide partial pressure, and peripheral oxygen saturation were measured, and adverse events were recorded. Ventilation was satisfactory in all patients. Peripheral saturation remained greater than 94% in 19 of the 20 (95%) procedures. Stenosis internal diameter and grading were improved. Two patients had minor reversible adverse events (coughing and laryngospasm), which did not prevent completion of the procedure. CONCLUSIONS: The authors report the first human trial of the device, in which continuous conventional ventilation could be provided during all tracheal balloon dilatation procedures. Larger trials are needed to confirm improved patient safety and comparative efficacy.