Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation

Capital Medical University250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Interventions

Standardized Stepwise Weaning ProtocolOTHER

The intervention was a standardized stepwise weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. Clinical stability and readiness for weaning were assessed before protocol initiation. Ventilator support was gradually reduced according to patient tolerance. When patients met predefined readiness criteria, spontaneous breathing trials were performed under pressure support ventilation. Patients who tolerated spontaneous breathing trials transitioned to progressively longer periods of high-flow oxygen therapy delivered through the tracheostomy tube. Noninvasive ventilation was used when appropriate to support transition from invasive ventilation and facilitate liberation from ventilatory support. Patients were reconnected to the ventilator if signs of respiratory distress or clinical instability occurred. Airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment were integrated throughout the protocol.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Participants With Successful Weaning Within 60 Days

Successful weaning was defined as breathing without invasive mechanical ventilator assistance for at least 5 consecutive days. The outcome was calculated as the percentage of enrolled participants who achieved successful weaning within 60 days after enrollment.

Time frame: From enrollment to 60 days after enrollment

Secondary Outcomes

Time From Enrollment to Successful Weaning

Weaning duration was defined as the number of days from enrollment to the first day on which the participant met the definition of successful weaning.

Time frame: From enrollment to successful weaning, assessed up to 60 days after enrollment

Percentage of Successfully Weaned Participants Reconnected to Invasive Ventilation Within 30 Days

Reconnection was defined as the need to resume invasive mechanical ventilator assistance within 30 days after successful weaning. This outcome was calculated among participants who achieved successful weaning.

Time frame: From successful weaning to 30 days after successful weaning

All-Cause Mortality at 6 Months

All-cause mortality was defined as death from any cause within 6 months after enrollment.

Time frame: From enrollment to 6 months after enrollment