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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Successful Weaning Within 60 Days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standardized Weaning Protocol
Participants in this single-group study received a standardized stepwise weaning protocol in a specialized weaning unit. The protocol included daily assessment of clinical stability and weaning readiness, gradual reduction of ventilatory support, spontaneous breathing trials when clinically feasible, early noninvasive ventilation when appropriate, progressive high-flow oxygen therapy through the tracheostomy tube, airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment.
干预措施: Standardized Stepwise Weaning Protocol (Other)
结局指标
主要结局
Percentage of Participants With Successful Weaning Within 60 Days
时间窗: From enrollment to 60 days after enrollment
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.
次要结局
- Time From Enrollment to Successful Weaning(From enrollment to successful weaning, assessed up to 60 days after enrollment)
- Percentage of Successfully Weaned Participants Reconnected to Invasive Ventilation Within 30 Days(From successful weaning to 30 days after successful weaning)
- All-Cause Mortality at 6 Months(From enrollment to 6 months after enrollment)
研究者
Jingyi Ge
Principal Investigator
Capital Medical University