Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation

NCT06642714 | Completed

• 1 other identifier: 2025Z-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolonged Mechanical Ventilation; Ventilator Weaning; Tracheostomy

Keywords

Prolonged mechanical ventilation; Tracheostomy; Ventilator weaning; Noninvasive ventilation; High-flow oxygen therapy; Specialized weaning unit; Rehabilitation hospital

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 60 days after enrollment

Secondary Outcomes (3)

• 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

Study Arms (1)

Standardized Weaning Protocol

EXPERIMENTAL

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.

Other: Standardized Stepwise Weaning Protocol

Interventions

Standardized Stepwise Weaning Protocol OTHER

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.

Standardized Weaning Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital of Capital Medical University

Beijing, China

Location

Study Officials

• Jingyi Ge

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Jingyi Ge

  Beijing Rehabilitation Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single-group interventional study evaluating a standardized stepwise weaning protocol in tracheostomized patients requiring prolonged mechanical ventilation in a specialized weaning unit.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)