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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy; Ventilator Weaning; Prolonged Mechanical Ventilation
• Intervention / Treatment: Other: Standardized Stepwise Weaning Protocol

Detailed Description

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
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Rehabilitation Hospital of Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Standardized Stepwise Weaning Protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From enrollment to 6 months after enrollment

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Jingyi Ge, Study Principal Investigator; Principal Investigator: Jingyi Ge, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Tracheostomy; Noninvasive ventilation; Ventilator weaning; Prolonged mechanical ventilation; High-flow oxygen therapy; Specialized weaning unit; Rehabilitation hospital
• Other Study ID Numbers: 2025Z-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No