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Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation

NCT06642714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Jingyi Ge · Study Principal Investigator

  • Jingyi Ge · Beijing Rehabilitation Hospital of Capital Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-31
Completion
2026-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642714 on ClinicalTrials.gov