Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation

Early Noninvasive Ventilation and Progressive High-Flow Oxygen Therapy Through a Tracheostomy Tube Weaning Protocol in Tracheostomized Patients With Prolonged Mechanical Ventilation: A Prospective Single-Arm Interventional Study

This study evaluated the feasibility and clinical outcomes of a standardized weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. The protocol was delivered in a specialized weaning unit of a tertiary rehabilitation hospital and combined early noninvasive ventilation, progressive high-flow oxygen therapy through the tracheostomy tube, spontaneous breathing trials when appropriate, and stepwise reduction of ventilatory support. The main outcome was successful liberation from mechanical ventilation within 60 days.

Patients who require prolonged mechanical ventilation after tracheostomy often have respiratory muscle weakness, impaired load-capacity balance, multiple comorbidities, and a high risk of delayed liberation from mechanical ventilation. These patients may have difficulty tolerating abrupt transition to unsupported breathing, and conventional weaning approaches may not be sufficient for all patients.

This study was conducted in a specialized weaning unit of a tertiary rehabilitation hospital. The intervention was a standardized, stepwise weaning protocol for tracheostomized patients with prolonged mechanical ventilation. The protocol included daily assessment of clinical stability and readiness for weaning, gradual reduction of ventilatory support, early use of noninvasive ventilation when appropriate, progressive high-flow oxygen therapy delivered through the tracheostomy tube, spontaneous breathing trials when clinically feasible, airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment.

The purpose of the protocol was to facilitate safe liberation from mechanical ventilation while minimizing the risk of weaning failure and early reconnection to ventilatory support. Participants were followed for weaning outcomes, reconnection after successful weaning, survival status, and other clinical outcomes according to the study protocol.

Inclusion Criteria:

• Age 18 years or older;
• Tracheostomy in place at the time of referral or enrollment;
• Prolonged mechanical ventilation, defined according to the National Association for Medical Direction of Respiratory Care consensus as the need for invasive mechanical ventilation for more than 6 hours per day for at least 21 consecutive days;
• Consecutively referred or admitted to the specialized weaning unit between January 1, 2025 and October 31, 2025 for active weaning rehabilitation;
• Written informed consent provided by the participant or the participant's legally authorized representative.

Exclusion Criteria:

• Referral intended solely for clinical stabilization before discharge to home or nursing care rather than for an active weaning attempt;
• End-stage disease with life expectancy of less than 3 months;
• Death or discharge within 14 days after referral;
• Refusal to provide informed consent.